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Drug recall · FDA · Published March 15, 2021

Cardinal Health Inc. recalls Edarbi (azilsartan medoxomil) tablets 80 mg 30 Tablets Rx Only NDC 60631-080-30 Manufactured for: arbor Pharmaceuticals

Cardinal Health recalls Edar: 80mg tablets due to potential temperature exposure during storage. This may affect drug stability. Check NDC 60631-080-30 for affected units.

🇺🇸 FDA recall #D-0429-2021DrugCardinal Health ›
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Contact the company & request your remedy

Recalling firmCardinal Health Inc.7000 Cardinal Pl, N/A · Dublin, OH 43017-1091
No email on file for this recall — reach the company by phone or its official page instead.No email on file — write to the address above instead.
✎ GovInfoNow plain-language explainer

What happened, in plain English

Cardinal Health is recalling Edarbi (azilsartan medoxomil) 80mg tablets because they may have been exposed to temperature changes during storage. This could affect the drug's stability and safety for patients. Read more at govinfonow.com/recall/36280-edarbi-80mg-tablets-recall-temperature-storage-risk.

Source Summary by GovInfoNow · govinfonow.com/recall/36280-edarbi-80mg-tablets-recall-temperature-storage-risk · Updated October 4, 2026 · FDA enforcement record: FDA #D-0429-2021

Cite this page

“Edarbi 80mg Tablets Recall: Temperature Storage Risk.” GovInfoNow, updated October 4, 2026. https://govinfonow.com/recall/36280-edarbi-80mg-tablets-recall-temperature-storage-risk. Based on FDA recall #D-0429-2021 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0429-2021%22&limit=1).

Why it’s dangerous

The tablets may have been exposed to temperature fluctuations during storage, which could affect their stability. This might lead to reduced effectiveness or potential safety issues for patients.

Who’s affected

Prescription patients who received Edarbi 80mg tablets with NDC 60631-080-30 from Cardinal Health. Patients taking this medication for hypertension are most at risk.

How to tell if you have this one

Check for Edarbi 80mg tablets with NDC 60631-080-30. The product was manufactured for arbor Pharmaceuticals in Atlanta, GA.

  • Brand
    Cardinal Health
  • Category
    Drug
FDA recall event · 198 products

All 198 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

  • Classification
    Class II
  • Status
    Terminated
  • Distribution
    FL, GA, SC
Recall numberProduct, codes & lotsQuantityNDC
D-0400-2021THERAPEUTIC M 130; NDC/UPC 740985223680; OTC; TABLETS; All Lots distributed 02/23/2021 through 03/10/2021.55 bottles—
D-0401-2021NIACIN 250MG 110; NDC/UPC 740985228494; OTC; TABLETS; All Lots distributed 02/23/2021 through 03/10/2021.4 bottles—
D-0402-2021Creon (pancrelipase) Delayed-Release Capsules Dose By Lipase Units Lipase 36,000 USP Units Rx only NDC 0032-3016-13 100 Capsules Marketed by: AbbVie Inc. North Chicago, IL 60064, U.S.A.; 11394941669 bottles0032-1203-70, 0032-1203-64, 0032-1206-07, 0032-1206-01, 0032-1206-56, 0032-1212-07, 0032-1212-01, 0032-1212-46, 0032-1212-13, 0032-1224-07, 0032-1224-01, 0032-1224-46, 0032-3016-28, 0032-3016-13, 0032-3016-50, 0032-3016-12, 0032-0045-70, 0032-0045-30, 0032-0046-30, 0032-0046-70, 0032-0047-30, 0032-0047-70, 0032-2636-70, 0032-2636-01, 0032-2636-30, 0032-2637-70, 0032-2637-01, 0032-2637-30
D-0403-2021Orilissa elagolix tablets 150 mg per tablet equivalent to 155.2 mg elagolix sodium, 28 Tablets For 28 Days Rx only NDC 0074-0038-28 Each carton contains 28 tablets in 4 weekly blister pack, Each weekly blister pack contains 7 tablets of elagolix 150 mg AbbVie Inc. North Chicago, IL 60064; 1120778210 cartons0074-0038-28, 0074-0038-01, 0074-0038-07, 0074-0039-56, 0074-0039-01, 0074-0039-14
D-0404-2021Norvir Ritonavir Tablets 100 mg 30 Tablets Rx only NDC 0074-3333-30 Abbott Laboratories North Chicago, IL 60064, U.S.A.; 1131141362 bottles0074-3333-30, 0074-1940-63, 0074-3399-30, 0074-2340-30
D-0405-2021Synthroid (levothyroxine sodium tablets, USP) in all pack sizes, styles and concentrations Rx only Abbott Laboratories North Chicago, IL; 1138959123 bottles—
D-0406-2021METHOCARBAMOL 500MG 500; NDC/UPC 71093014005; RX; TABLETS; UMETA0036A51 bottles—
D-0407-2021FENOFIBRATE CAPSULES, UPS 67MG 100 CAPSULES NDC/UPC 27241-118-04; RX; CAPSULES; PA03410106 BOXES27241-118-04, 27241-118-05, 27241-119-04, 27241-119-05, 27241-120-04, 27241-120-05
D-0408-2021OFLOXACIN 0.3% 5ML OPTH; NDC/UPC 17478071310; RX; DROPS; 427297339 bottles—
D-0409-2021LIDOCAINE HCL VISC 2% 100ML; NDC/UPC 50383077504; RX; SOLUTION (USUALLY NOT OTIC, OPTH, NASAL DROPS); 373577240 bottles—
D-0410-2021Atropine Sulfate Ophthalmic Solution, USP 1% For Topical Application To The Eye Sterile 5 mL Rx only NDC 17478-215-05 Manufactured by: Akorn, Inc.; 071520A424 bottles—
D-0411-2021COSOPT (Dorzolamide Hydrochloride-Timolol Maleate Ophthalmic Solution) (Dorzolamide Hydrochloride 22.3 mg/mL Timolol Maleate 6.8 mg/mL) 10ML Ocumeter Plus Ophthalmic Dispenser Sterile Ophthlamic Solution Rx only NDC/UPC 174780-605-10 Distributed by: Akorn, Inc. Lake Forest, IL 60045; 43035812 bottles—
D-0412-2021Metoprolol Tartrate and Hydrochlorothiazide Tablets, USP 50 mg/25 mg 100 Tablets Rx only NDC 62332-115-31 Manufactured for: Alembic Pharmaceuticals, Inc. 750 Route 202, Bridgewater, NJ 08807 USA; 200500574571 bottles62332-115-30, 62332-115-31, 62332-115-91, 62332-116-30, 62332-116-31, 62332-116-71, 62332-117-30, 62332-117-31, 62332-117-71, 2005005745
D-0413-2021BROMFENAC OPHTHALMIC SOLUTION 0.09% 1.7ML NDC/UPC 62332-508-17; RX; DROPS; AGV009152 CARTON62332-508-17
D-0414-2021Vaniqa (eflornithine hydrochloride) Cream, 13.9% For Topical Use Only Net wt. 1.59 oz (45 g) Rx only NDC 0023-4857-45 Manufactured for Allegan, Inc. Irvine, CA 92612; 11378072 tubes—
D-0415-2021UBRELVY 100MG 10UD CPLT; NDC/UPC 23650110; RX; TABLETS; 1658641964 bottles—
D-0416-2021RESTASIS 0.05%30X 0.4ML OPTH PF; NDC/UPC 23916330; RX; DROPS/Restasis 0.05% 60x0.4 mL OPTH PF; NDC/UPC 23916330; RX; T12023688 bottles—
D-0417-2021Linzess (linaclotide) capsules 72 mcg/capsule 30 capsules Rx Only NDC 0456-1203-30 Distributed by: Allergan USA, Inc. Irvine, CA 92612; W044111529 bottles0456-1203-30, 0456-1203-04, 0456-1203-07, 0456-1201-30, 0456-1201-04, 0456-1201-07, 0456-1202-30, 0456-1202-04, 0456-1202-07
D-0418-2021Namzaric (memantine HCl extended release and donepezil HCl) capsules 14 mg/10 mg per capsule 30 capsules Rx Only NDC 0456-1214-30 Distributed by Forest Pharmaceuticals, Inc. Subsidiary of Forest Laboratories, LLC.; W04815659 bottles0456-1207-30, 0456-1214-11, 0456-1214-30, 0456-1214-63, 0456-1214-90, 0456-1221-30, 0456-1228-30, 0456-1228-90, 0456-1228-63, 0456-1228-11, 0456-1229-29, 0456-1229-04
D-0419-2021Rectiv (nitroglycerin) Ointment 0.4% For Intra-anal Use Only 30 g Rx Only NDC 58914-301-80 Mfd. by: Pharbil Waltrop GmbH, Im Wirrigen 25, 45731 Waltrop, Germany Distributed by: Aptalis Pharma US, Inc. Birmingham, AL 35242; 239907031 tubes58914-301-80, 58914-301-85
D-0420-2021Vraylar (cariprazine) capsules in all pack sizes, styles and strengths Rx only Distributed by: Actavis Pharma, Inc. Parsippany, NJ 07054; W04494759 bottles—
D-0421-2021Nitrofurantoin Macrocrystals Capsules 25 mg 100 Capsules Rx Only NDC 47781-306-01 Manufactured by: Norwich Pharmaceuticals, Inc. Norwich, NY 13815 Distributed by: Alvogen, Inc. Parsippany, NJ 07054 U.S.A.; 48694215 bottles47781-306-01, 47781-307-01, 47781-308-01
D-0422-2021BUPRENORPHINE AND NALOXONE SUBLINGUAL FILM 4MG/1MG 30 POUCHES EACH CONTAINING 1 SUBLINGUAL FILM NDC/UPC 47781-0356-03; RX; FILM; 37890249 CARTONS—
D-0423-2021Oseltamivir Phosphate for Oral Suspension 6 mg/mL* *Each mL contains 6 mg oseltamivir base after constitution. 60 mL (usable volume after constitution) Rx Only NDC 47781-384-26 Distributed by: Alvogen, Inc. Pine Brook, NJ 07058 USA; 48424115885 bottles47781-384-26
D-0424-2021ERYTHROMYCIN TABLETS, USP 250MG 30; NDC/UPC 69238-1484-3; RX; TABLETS; AM200540135 CARTON—
D-0425-2021TRAVOPROST OPHTHALMIC SOLUTION, USP 0.004% 2.5ML ; NDC/UPC 60505-0593-4; RX; DROPS; RW4409325 CARTONS60505-0593-4, 60505-0593-1
D-0426-2021ENOXAPARIN DOFIUM INJRVYION, UPD 150MG/1ML 10X1ML SINGLE DOSE SYRINGES; NDC/UPC 60505-0798-4; RX; SYRINGES; CV00664 BOXES—
D-0427-2021Butorphanol Tartrate Nasal Solution USP 10 mg/mL 2. 5 mL bottles Rx Only NDC 60505-0813-1 Mfg by: Apotex Inc. Toronto, Ontario Canada M9L 1T9; RT711338 bottles60505-0813-1
D-0428-2021Timolol Maleate Ophthalmic Solution, USP 0.5% 2.5 mL Sterile For Topical Application In The Eye Rx Only NDC 60505-1005-4 Manufactured by: Apotex Inc. Toronto, Ontario Canada M9L 1T9 Manufactured for: Apotex Corp. Weston, FL 33326; RV737831 droptainers—
D-0429-2021Edarbi (azilsartan medoxomil) tablets 80 mg 30 Tablets Rx Only NDC 60631-080-30 Manufactured for: arbor Pharmaceuticals Atlanta, GA 30328; 78902-1328 bottles60631-040-07, 60631-040-30, 60631-040-77, 60631-080-07, 60631-080-30, 60631-080-77
D-0430-2021edarbyclor Azilsartan Medoxomil and Chlorthalidone Tablets 40 mg*/12.5 mg 30 Tablets Rx Only NDC 60631-412-30 Manufactured for: arbor Pharmaceuticals, LLC. Atlanta, GA 30328; 78520244 bottles60631-412-30, 60631-425-30
D-0431-2021edarbyclor Azilsartan Medoxomil and Chlorthalidone Tablets 40 mg*/25 mg *Each tablet contains: 42.68 mg azilsartan kamedoxomil (equivalent to 40 mg azilsartan medoxomil) and 25 mg chlorthalidone. 30 Tablets Rx Only NDC 60631-425-30 Manufactured for Arbor Pharmaceuticals Atlanta, GA 30328; 79551273 bottles60631-412-30, 60631-425-30
D-0432-2021GEMCITABINE INJECTION 200MG/5.26ML; NDC/UPC 72485-221-02; RX; SINGLEDOSE VIAL; 7T10050A3 CARTON—
D-0433-2021Brilinta ticagrelar tablets 60 mg 60 tablets Rx only NDC 0186-0776-60 Mfd. for: AstraZeneca LP, Wilmington, DE 19850; MP01381278 bottles0186-0777-08, 0186-0777-60, 0186-0777-18, 0186-0777-39, 0186-0777-28, 0186-0776-60, 0186-0776-94
D-0434-2021Bevespi Aerosphere (glycopyrrolate and formoterol fumarate) Inhalation Aerosol 9 mcg/4.8 mcg per inhalation For Oral Inhalation only 120 inhalations Rx Only NDC 0310-4600-12 Mfd for: AstraZeneca Pharmaceuticals, LP, Wilmington, DE 19850; 6030180A00355 inhalers0310-4600-12, 0310-4600-28, 0310-4600-39
D-0435-2021xigduo XR (dapgliflozin/metformin HCl extended-release) tablets 10 mg/1000 mg 30 Tablets Rx only NDC 0310-6280-30 Manufactured for: AstraZeneca Pharmaceuticals LP Wilmington, DE 19850 Manufactured by: Bristol-Myers Squibb Manufacturing Company Humacao, Puerto Rico 00791; MP0077664 bottles0310-6270-30, 0310-6270-95, 0310-6280-30, 0310-6280-95, 0310-6250-30, 0310-6250-95, 0310-6260-30, 0310-6260-60, 0310-6260-94, 0310-6260-95, 0310-6225-60, 0310-6225-94
D-0436-2021xigduo XR (dapagliflozin/metformin HCl extended-release) tablets 5 mg/1000 mg 60 Tablets Rx only NDC 0310-6260-60 Manufactured for: AstraZeneca Pharmaceuticals LP Wilmington, DE 19850; ML0171378 bottles0310-6270-30, 0310-6270-95, 0310-6280-30, 0310-6280-95, 0310-6250-30, 0310-6250-95, 0310-6260-30, 0310-6260-60, 0310-6260-94, 0310-6260-95, 0310-6225-60, 0310-6225-94
D-0437-2021IBUPROFEN ORAL SUSPENSION USP 100MG/5ML 120ML ; NDC/UPC 59651-032-12; RX; SUSPENSION (NO DROPS); BO1020069-A345 CARTONS59651-032-12, 59651-032-47
D-0438-2021Eletriptan Hydrobromide Tablets 20 mg* 6(1x6) Unit-dose Tablets Rx only NDC 59651-104-69 Distributed by: Aurobindo Pharma USA, Inc. 279 Princeton-Highstown Road East Windsor, NJ 08520; EA2020001-A20 CARTONS59651-104-06, 59651-104-69, 59651-105-06, 59651-105-69, 59651-105-93
D-0439-2021AMOXICILLIN 500MG 100; NDC/UPC 65862001401; RX; TABLETS; SE5019062-A373 bottles—
D-0440-2021ONDANSETRON HCL 4MG 30; NDC/UPC 65862018730; RX; TABLETS; ON0420015-A1935 bottles—
D-0441-2021ESZOPICLONE 3MG 100 C4; NDC/UPC 65862096901; RX; TABLETS; GS0320010-A29 bottles—
D-0442-2021Nuedexta (dextromethorphan HBr and quinidine sulfate) Capsules 20 mg/10 mg 60 capsules Rx only NDC 64597-301-60 Manufactured by Patheon, Inc. Whitby, ON L1N 5Z5, Canada; CFBFP255 bottles64597-301-13, 64597-301-60
D-0443-2021LOTEMAX SM (loteprednol etabonate ophthalmic gel) 0.38% 5GM; NDC/UPC 24208-0507-07; RX; GEL; 352162463 boxes—
D-0444-2021BENZEFOAM EMOLLIENT FOAM BENZOYL PEROXIDE 5.3% 100GM TOP EMOL NDC 187-0194--10; OTC; FOAMS; All Lots distributed 02/23/2021 through 03/10/2021.2 carton—
D-0445-2021MURO-128 2% 15ML OPTH; NDC/UPC 324208276150; OTC; DROPS; All Lots distributed 02/23/2021 through 03/10/2021.64 droptainers—
D-0446-2021TOBRAMY/DEX 0.3-0.1% 10ML OPTH; NDC/UPC 24208029510; RX; DROPS; 35086147 droptainers—
D-0447-2021DEXAMETH SOD PHOS 0.1% 5ML; NDC/UPC 24208072002; RX; DROPS; 353351318 droptainers—
D-0448-2021Belbuca (buprenorphine hydrochloride) buccal film 300 mcg 60 pouches containing 1 buccal film each Rx only NDC 59385-023-60 Manufactured for: BioDelivery Sciences International, Inc. Raleigh, NC 27612.; 37674B96 cartons59385-021-01, 59385-021-60, 59385-022-01, 59385-022-60, 59385-023-01, 59385-023-60, 59385-024-01, 59385-024-60, 59385-025-01, 59385-025-60, 59385-026-01, 59385-026-60, 59385-027-01, 59385-027-60
D-0449-2021Belbuca (buprenorphine hydrochloride) buccal film 600 mcg 60 pouches containing 1 buccal film each Rx only NDC 59385-025-60 Manufactured for: BioDelivery Sciences International, Inc. Raleigh, NC 27612 USA; BL600200447 cartons59385-021-01, 59385-021-60, 59385-022-01, 59385-022-60, 59385-023-01, 59385-023-60, 59385-024-01, 59385-024-60, 59385-025-01, 59385-025-60, 59385-026-01, 59385-026-60, 59385-027-01, 59385-027-60
D-0450-2021SYMPROIC (NAIDEMEDINE) TABLETS 0.2MG 30 TABLETS; NDC 59385-041-30; RX; TABLETS; 2003060A67 BOXES59385-041-30, 59385-041-07
D-0451-2021NURTEC ODT (RIMEGEPANT) 75MG 8 BPK; NDC/UPC 72618-3000-2; RX; TABLETS FOR RAPID DISSOLUTION (NOT SUBLINGUAL); 41703261240 CARTON72618-3000-2, 72618-3001-1, 72618-3001-2, 72618-3001-4
D-0452-2021CATAPRES-TTS-2 1X4; NDC/UPC 597003234; RX; ADHESIVE PATCHES; 1905666/217 patches—
D-0453-2021Spiriva HandiHaler (tiotropium bromide inhalation powder) For Oral Inhalation Only 18 mcg (as tiotropium) per capsule Rx only NDC 0597-0075-41 Manufactured by: Boehringer Ingelheim (BI) Pharma GmbH & Co. KG Ingelheim, Germany Marketed by: Boehringer Ingelheim Pharmaceuticals, Inc. Ridgefield, CT 06877 USA and Pfizer, Inc. New York, NY 10017 USA; 50982611 inhalers0597-0075-41, 0597-0075-75, 0597-0075-47
D-0454-2021ATROVENT HFA 17MCG 12.9GM; NDC/UPC 597008717; RX; INHALER MEDICAL INTERNAL - MAY OR MAY NOT BE AEROSOL; 200155667 inhalers—
D-0455-2021Glyxambi (empagliflozin and linagliptin) Tablets 25 mg/5 mg 30 tablets Rx only NDC 0597-0164-30 Dist. by: Boehringer Ingelheim (BI) Pharmaceuticals, Inc. Ridgefield, CT 06877 USA; 3513592 bottles0597-0182-70, 0597-0182-07, 0597-0182-03, 0597-0182-30, 0597-0182-39, 0597-0182-90, 0597-0164-30, 0597-0164-39, 0597-0164-90, 0597-0164-70, 0597-0164-07
D-0456-2021Synjardy (empagliflozin and metformin hydrochloride) Tablets 12.5 mg/1000 mg 60 tablets Rx only NDC 0597-0168-69 Distributed by: Boehringer Ingleheim (BI) Pharmaceuticals, Inc. Ridgefield, CT 06877 USA; C80102284 bottles—
D-0457-2021Jentadueto XR (linagliptin and metformin hydrochloride extended-release) Tablets 5 mg/1000 mg 30 tablets Rx only NDC 0597-0275-33 Dist. by: Boehringer Ingleheim (BI) Pharmaceuticals, Inc. Ridgefield, CT 06877 USA; 318986652 bottles0597-0270-12, 0597-0270-73, 0597-0270-94, 0597-0275-33, 0597-0275-81, 0597-0275-88
D-0458-2021Synjardy XR (empagliflozin and metformin hydrochloride extended-release) Tablets 25 mg/1000 mg 30 tablets Rx only NDC 0597-0295-88 Dist. by: Boehringer Ingelheim (BI) Pharmaceuticals, Inc., Ridgefield, CT 06877 USA; 3191432269 bottles0597-0280-36, 0597-0280-73, 0597-0280-90, 0597-0290-20, 0597-0290-59, 0597-0290-74, 0597-0295-61, 0597-0295-78, 0597-0295-88, 0597-0300-20, 0597-0300-45, 0597-0300-93
D-0459-2021Synjardy XR (empagliflozin and metformin) hydrochloride extended-release) Tablets 12.5 mg/1000 mg 60 tablets Rx only NDC 0597-0300-45 Dist. by: Boehringer Ingelheim (BI) Pharmaceuticals, Inc. Ridgefield, CT 06877 USA; 3190949751 bottles0597-0280-36, 0597-0280-73, 0597-0280-90, 0597-0290-20, 0597-0290-59, 0597-0290-74, 0597-0295-61, 0597-0295-78, 0597-0295-88, 0597-0300-20, 0597-0300-45, 0597-0300-93
D-0460-2021PRAVACHOL 40MG 90; NDC/UPC 3519410; RX; TABLETS; ABA4203A13 bottles—
D-0461-2021Valsartan Tablets USP 40 mg 30 Scored Tablets Rx Only NDC 59746-360-30 Manufactured by: Jubilant Generics Ltd. Roorkee-247661, India; VR120022A20 bottles59746-360-30, 59746-360-90, 59746-360-05, 59746-360-03, 59746-361-30, 59746-361-90, 59746-361-05, 59746-361-03, 59746-362-30, 59746-362-90, 59746-362-05, 59746-362-03, 59746-363-30, 59746-363-90, 59746-363-67, 59746-363-32
D-0462-2021Sodium Sulfacetamide 9.8% & Sulfur 4.8% Cleanser (sodium sulfacetamide 9.8% and sulfur 4.8%) Net Wt. 10 oz. (285 g) Rx Only NDC 50096-502-10 Manufactured for: Rosemar Labs, LLC 2100 West Loop South Suite 900 Houston, TX 77027; 5931416 tubes—
D-0463-2021Meloxicam Tablets, USP 7.5 mg 100 Tablets Rx Only NDC 69097-158-07 Manufactured for: Cipla USA, Inc. 9100 S. Dadeland Blvd., Suite 1500 Miami, FL 33156; KA03034576 bottles69097-158-15, 69097-158-07, 69097-158-12, 69097-159-12, 69097-159-07, 69097-159-15
D-0464-2021Nadolol Tablets, USP 40 mg 100 Tablets Rx Only NDC 69097-868-07 Manufactured for: Cipla USA Inc. 9100 S. Dadeland Blvd., Suite 1599 Miami, FL 33156; NB10015640 bottles69097-867-07, 69097-867-15, 69097-867-02, 69097-868-02, 69097-868-07, 69097-868-15, 69097-869-02, 69097-869-07, 69097-869-15
D-0465-2021CIPROFLOX/D5W 400/200 24X200ML; NDC/UPC 36000000924; RX; IV SOLUTION (PIGGYBACK); A0D0924A40 bags—
D-0466-2021Prilosec (Omeprazole Magnesium) For Delayed-Release Oral Suspension 10 mg Rx only NDC 70515-610-01 Mfd. for: Covis Pharma, Zug, 6300 Switzerland; CACU13 packets70515-625-01, 70515-610-01
D-0467-2021Iron 100 with Vitamin C Tablets Dietary Supplement 100 Tablets NDC 60258-099-01 Distributed By: Cypress Pharmaceutical, Inc. 135 Industrial Blvd. Madison, MS 39110; All Lots distributed 02/23/2021 through 03/10/2021.1 bottle—
D-0468-2021BENICAR 40MG 30; NDC/UPC 65597010430; RX; TABLETS; 170329675 bottles—
D-0469-2021PREGABALIN CAPSULES 300MG 90 ; NDC 43598-298-90; RX; CAPSULES; T20003096 CONTAINERS43598-291-90, 43598-291-05, 43598-291-79, 43598-291-66, 43598-291-78, 43598-292-90, 43598-292-05, 43598-292-79, 43598-292-66, 43598-292-78, 43598-293-90, 43598-293-05, 43598-293-79, 43598-293-66, 43598-293-78, 43598-294-90, 43598-294-05, 43598-294-79, 43598-294-66, 43598-294-78, 43598-295-90, 43598-295-05, 43598-295-79, 43598-295-66, 43598-295-78, 43598-296-90, 43598-296-05, 43598-296-79, 43598-296-66, 43598-296-78, 43598-297-90, 43598-297-05, 43598-297-79, 43598-297-66, 43598-297-78, 43598-298-90, 43598-298-05, 43598-298-79, 43598-298-66, 43598-298-78
D-0470-2021Phenobarbital Tablets, USP 32.4 mg 100 tablets Rx only NdC 13517-111-01 Manufactured for: e5 Pharma, LLC., Boca Raton, FL 33432; 20ZHX2R1 bottle—
D-0471-2021Ivermectin Tablets USP 3 mg 20 Tablets (2 Foil Strips of 10 tablets each) Rx Only NDC 4799-806-01 Manufactured for: Edenbridge Pharmaceuticals, LLC Parsippany, NJ 07054 877-381-3336; A1003273A504 cartons—
D-0472-2021Banzel (rufinamide) tablets 200 mg 120 tablets Rx only NDC 62856-582-52 Manufactured by Eisai Co., Ltd. Marketed by Eisai Inc. Woodcliff Lake, NJ 07677; 8064330 bottles62856-582-52, 62856-582-04, 62856-583-14, 62856-583-52, 62856-584-46
D-0473-2021Narcan (naloxone HCl) Nasal Spray 4 mg Two Pack This box contains two (2) 4-mg doses of naloxone HCl in 0.1 mL of nasal spray. 0.1 mL intranasal spray per unit For use in the nose only Rx only NDC 69547-353-02 Distributed by Adapt Pharma, Inc. Radnor, PA 19087 USA; 20170111189 plungers69547-353-02
D-0474-2021BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE, AND DEXTROMETHORPHAN HYDROBROMIDE SYRUP 10-30-2MG/5ML 473ML; NDC/UPC 71930-026-43; RX; SYRUP; 13120103A73 carton71930-026-18, 71930-026-43
D-0475-2021Prenatal Tablets Gluten Free Multivitamin/ Multimineral Dietary Supplement for Pregnant and Lactating Women UD 100 Tablets (10x10) NDC 77333-715-10 GenDose Pharmaceuticals; All Lots distributed 02/23/2021 through 03/10/2021.41 bottles—
D-0476-2021cathflo activase (ALTEPLASE) 2 mg Rx Only NDC 50242-041-64 Genentech; 34104251473 vials50242-041-64, 50242-041-10
D-0477-2021FLOVENT DISKUS 100MCG 60; NDC/UPC 173060202; RX; INHALER MEDICAL INTERNAL - MAY OR MAY NOT BE AEROSOL; 9E9A237 inhalers—
D-0478-2021ADVAIR HFA 45-21MCG 12GM; NDC/UPC 173071520; RX; INHALER MEDICAL INTERNAL - MAY OR MAY NOT BE AEROSOL; TH4K297 inhalers—
D-0479-2021ARNUITY ELLIPTA 100MCG 30INH; NDC/UPC 173087410; RX; INHALER MEDICAL INTERNAL - MAY OR MAY NOT BE AEROSOL; F79E513 inhalers—
D-0480-2021Arnuity Ellipta (fluticasone furoate inhalation powder) 200 mcg 1 Ellipta Inhaler containing 1 Foil Strip of 30 Blisters Rx Only NDC 0173-0876-10 GlaxoSmithKline Research Triangle Park, NC 27709; 5U3D353 inhalers0173-0888-10, 0173-0874-10, 0173-0874-14, 0173-0876-10, 0173-0876-14
D-0481-2021TRELEGY ELLIPTA (FLUTICASONE FUROATE, UMEDIDINIUM AND VILANTEROL INHALATION POWDER) 100-62.5-25MCG 60; NDC/UPC 0173-0893-10; RX; INHALER MEDICAL INTERNAL - MAY OR MAY NOT BE AEROSOL; FN2J4065 CARTON0173-0887-10, 0173-0887-14, 0173-0887-61, 0173-0893-10, 0173-0893-14, 0173-0893-61
D-0482-2021Trelegy Ellipta (fluticasone furoate, umeclidinium, and vilanterol inhalation powder) 100 mcg/62.5 mcg/25 mcg; 1 ELLIPTA Inhaler containing 30 doses (60 blisters total) Rx Only NDC 0173-0887-10 GlaxoSmithKline Research Triangle Park, NC 27709; 3X8P903 inhalers0173-0887-10, 0173-0887-14, 0173-0887-61, 0173-0893-10, 0173-0893-14, 0173-0893-61
D-0483-2021Verapamil Hydrochloride Extended-Release Tablets USP 120 mg Rx Only NDC 68462-292-01 Manufactured by: Glenmark Generics Ltd Colvale-Bardez, Goa 403513, India Manufactured for: Glenmark Generics Inc., USA Mahwah, NJ 07430; 19205584513 bottles68462-292-90, 68462-292-01, 68462-292-05, 68462-293-90, 68462-293-01, 68462-293-05, 68462-260-30, 68462-260-90, 68462-260-01, 68462-260-05, 68462-260-10
D-0484-2021EZETIMIBE AND SIMVASTATIN TABLETS 10-10MG 30; NDC/UPC 68462-321-30; RX; TABLETS; 172016037 CARTON68462-321-90, 68462-321-10, 68462-321-30, 68462-322-30, 68462-322-90, 68462-322-10, 68462-323-30, 68462-323-90, 68462-323-05, 68462-324-30, 68462-324-90, 68462-324-05
D-0485-2021Theophylline (Anhydrous) Extended-Release Tablets 400 mg 100 Tablets Rx Only NDC 68462-380-01 Manufactured by: Glenmark Pharmaceuticals Limited Colvale-Bardez, Goa 403513, India Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430; 19205025141 bottles68462-380-01, 68462-380-05, 68462-356-01, 68462-356-05
D-0486-2021Triumeq (abacavir, dolutegravir, and lamivudine) 600 mg/50 mg/300 mg Tablets 30 Tablets Rx Only NDC 49702-231-13 Manufactured for: Viiv Healthcare Research Triangle Park, NC 27709 by GlaxoSmithKline Research Triangle Park, NC 27709; GS5G2264 bottles49702-231-13, 49702-258-37, 49702-272-59
D-0487-2021Hydrocortisone Ointment USP 1% Maximum Strength Net Wt. 1 oz (28 g) NDC 0472-0345-56 Manufactured by: Actavis Mid Atlantic LLC 1877 Kawai Road, Lincolnton, NC 28902; All Lots distributed 02/23/2021 through 03/10/202123 tubes—
D-0488-2021FaBB Vitamin B6 (as Pyridoxine Hydrochloride) 25 mg Folic Acid 2.2 mg Vitamin B12 (as Cyanocobalamin) 1.0 mg Dietary Supplement 100 Tablets Distributed by: H2-Pharma, LLC 2010 Berry Chase Place Montgomery, AL 36117; All Lots distributed 02/23/2021 through 03/10/2021.54 bottles—
D-0489-2021bupropion Hydrochloride Tablets, USP 75 mg 100 Tablets Rx only NDC 23155-191-01 Manufactured for: Heritage Pharmaceuticals Inc. Eatontown, NJ 07724; L20079132 bottles23155-191-10, 23155-191-01, 23155-192-10, 23155-192-01
D-0490-2021AcetaZOLAMIDE Tablets, USP 125 mg 100 Tablets Rx only NDC 23155-287-01 Manufactured for: Heritage Pharmaceuticals Inc. Eatontown, NJ 07724; M200833122 bottles23155-287-10, 23155-287-01, 23155-288-01, 23155-288-10
D-0491-2021Calcium Acetate Capsules 667 mg 200 Capsules Rx only NDC 23155-531-02 Manufactured for: Heritage Pharmaceuticals Inc. Eatontown, NJ 07724; L20080135 bottles23155-531-02, 23155-531-10, 23155-531-18
D-0492-2021LITHIUM CARB 150MG 100; NDC/UPC 54252625; RX; CAPSULES; AB1024A298 bottles—
D-0493-2021LEUCOVORIN 15MG 24; NDC/UPC 54449810; RX; TABLETS; 064159A12 bottles—
D-0494-2021Levofloxacin Injection in 5% Dextrose 500 mg in 100 mL 5% Dextrose (5 mg/mL) 24x100 mL Single Dose Flexible Containers NDC 0143-9721-24 West-Ward Pharmaceutical Corp Eatontown, NJ 07724 USA; 2007046.135 bags0143-9722-01, 0143-9722-24, 0143-9721-01, 0143-9721-24, 0143-9720-01, 0143-9720-24
D-0495-2021TIROSINT(levothyroxine sodium) capsules 175MCG 3 blisters X10 capsules; NDC/UPC 71858-0055-4; RX; CAPSULES; 20060625 boxes71858-0013-4, 71858-0013-1, 71858-0013-2, 71858-0012-4, 71858-0012-1, 71858-0012-2, 71858-0005-4, 71858-0005-1, 71858-0005-2, 71858-0010-4, 71858-0010-1, 71858-0010-2, 71858-0015-4, 71858-0015-1, 71858-0015-2, 71858-0020-4, 71858-0020-1, 71858-0020-2, 71858-0025-4, 71858-0025-1, 71858-0025-2, 71858-0030-4, 71858-0030-1, 71858-0030-2, 71858-0035-4, 71858-0035-1, 71858-0035-2, 71858-0040-4, 71858-0040-1, 71858-0040-2, 71858-0045-4, 71858-0045-1, 71858-0045-2, 71858-0050-4, 71858-0050-1, 71858-0050-2, 71858-0055-4, 71858-0055-1, 71858-0055-2, 71858-0060-4, 71858-0060-1, 71858-0060-2, 71858-0017-4, 71858-0017-1, 71858-0017-2
D-0496-2021Enbrace HR 30 ct. Softgels Enhanced Prenatal Vitamin Supplement Rx NDC 64661-650-30 Manufactured for: JAYMAC Pharmaceuticals, LLC, Sunset, LA 70584; All Lots distributed 02/23/2021 through 03/10/2021.11 bottles64661-650-30
D-0497-2021Tylenol Acetaminophen Pain Regular Strength Liquid Gels Pain Reliever Fever Reducer 20 Liquid Gels 325 mg each NDC 50580-487-20; All Lots distributed 02/23/2021 through 03/10/2021.37 bottles—
D-0498-2021INVEGA SUSTENNA 156MG/1ML; NDC/UPC 50458056301; RX; SYRINGES; KIB0M00534 syringes—
D-0499-2021Auryxia (ferric citrate) tablets 210 mg* 200 Tablets Rx Only NDC 59922-631-01 Manufactured for and distributed by: Keryx Biopharmaceuticals, Inc. 750 Lexington Avenue, 20th Floor New York, NY 10022 USA; AN0142D136 bottles59922-631-01
D-0500-2021Livalo (pitavastatin) tablets 2 mg* Rx Only NdC 66869-204-90 Manufactured under license from: Kowa Company, Limited Tokyo 103-8433 Japan Tablets Manufactured by: Patheon, Inc. Cincinnati, OH 45237 USA or by Kowa Company, Ltd Nagoya 462-0024 Japan; 3193479453 bottles66869-104-90, 66869-204-90, 66869-204-07, 66869-404-90, 66869-404-07
D-0501-2021PHENTERMINE HCL 30MG 100 C4; NDC/UPC 10702002801; RX; CAPSULES; 16667A16 bottles—
D-0502-2021PHENTERMINE HCL 37.5MG 100 C4; NDC/UPC 10702002901; RX; CAPSULES; 16649A237 bottles—
D-0503-2021Infants Aqueous Vitamin D Oral Drops 400 IU/mL 50 mL (1 2/3 fl oz) Manufactrued by: Silarx Pharmaceuticals, Inc. 19 West Street Spring Valley, NY 10977 USA; All Lots distributed 02/23/2021 through 03/10/2021.422 bottles—
D-0504-2021Ferrous Sulfate 75 mg (equivalent to 15 mg Iron) Per 1.0 mL Alcohol 0.2% v/v Drops Iron Supplement Drops For Infants and Toddlers 50 mL (1 2/3 fl oz) NDC 54838-011-50 Manufactured by: Silarx Pharmaceuticals, Inc. 19 West Street Spring Valley, NY 10977 USA; All Lots distributed 02/23/2021 through 03/10/2021.357 bottles—
D-0505-2021SILADRYL 12.5/5ML 118ML SF AF; NDC/UPC 354838135404; OTC; LIQUID; All Lots distributed 02/23/2021 through 03/10/2021.78 bottles—
D-0506-2021Pantoprazole Sodium Delayed-Release Tablets, USP 20 mg* 90 Tablets Rx Only NDC 62175-180-46 Distributed by: Kremers Urban Pharmaceuticals Inc. Princeton, NJ 08540, USA; 20249489A4 bottles62175-617-46, 62175-617-43, 62175-180-46, 62175-180-43, 62175-618-46, 62175-618-43
D-0507-2021NOHIST-DM Antihistamine/Antitussive Nasal Decongestant 16 fl. oz. (473 mL) NDC 68047-186-16 Distributed by: Larken Laboratories, Inc. Canton, MS 39046; All Lots distributed 02/23/2021 through 03/10/2021.24 bottles68047-186-16
D-0508-2021TRI-LO-MARZIA 0.180MG/0.025MG; 0.215 MG/0.025MG AND 0.250MG/0.025MG 3X28 BPK; NDC/UPC 68180-837-73; RX; TABLETS; L00191160 CARTON68180-837-73
D-0509-2021Amlodipine and Olmesartan Medoxomil Tablets 10 mg/20 mg 30 Tablets Rx Only NDC 33342-192-07 Manufactured for: Macleods Pharma USA, Inc. Plainsboro, NJ 08536 Manufactured by: Macleods Pharmaceuticals Ltd. Baddi, Himachal Pradesh, India; BAD62005A33 bottles33342-190-07, 33342-190-10, 33342-190-12, 33342-190-44, 33342-191-07, 33342-191-10, 33342-191-12, 33342-191-44, 33342-192-07, 33342-192-10, 33342-192-12, 33342-192-44, 33342-193-07, 33342-193-10, 33342-193-12, 33342-193-44
D-0510-2021TRAZODONE HYDROCHLORIDE TABLETS, USP 50MG 100 TABLET 10X10UD; NDC/UPC 0904-6868-61; RX; TABLETS; R0158091 CARTON0904-6868-61, 0904-6869-61, 0904-7212-61
D-0511-2021MICONAZOLE 7 2% 45GM APL; NDC/UPC 009047734459; OTC; CREAM; All Lots distributed 02/23/2021 through 03/10/2021.71 tubes—
D-0512-2021Banophen Diphenhydramine HCl 25 mg Antihistamine 100 capsules NDC 0904-5306-60 Distributed by: Major Pharmaceuticals 31778 Enterprise Drive Livonia, MI 48150 USA; All Lots distributed 02/23/2021 through 03/10/202188 bottles0904-5306-60, 0904-5306-80, 0904-5306-61, 0904-5306-24, 0904-2056-61, 0904-2035-24
D-0513-2021Acne Medication Benzoyl Peroxide Gel USP, 5% Net Wt 1.5 oz (42.5 g) NDC 0536-1055-56 Distributed by: Rugby Laboratories 31778 Enterprise Drive, Livonia, MI 48150; All Lots distributed 02/23/2021 through 03/10/2021.189 tubes0536-1055-56, 0536-1055-25, 0536-1055-57
D-0514-2021VITAMIN D3 50MCG 100 SOFTGELS; NDC/UPC 880681009000; OTC; GELCAP; All Lots distributed 02/23/2021 through 03/10/2021.380 BOTTLE—
D-0515-2021VITAMIN D3 25MCG 90 TABLETS; NDC/UPC 880681168004; OTC; TABLETS; All Lots distributed 02/23/2021 through 03/10/2021.53 BOTTLE—
D-0516-2021VITAMIN D3 25MCG 180 TABLETS; NDC/UPC 880681168011; OTC; TABLETS; All Lots distributed 02/23/2021 through 03/10/2021.19 BOTTLE—
D-0517-2021DIBUCAINE TOPICAL ANESTHETIC 1% HEMORRHOIDAL OINTMENT 28GM ; NDC/UPC 0536-1211-95; OTC; OINTMENT; All Lots distributed 02/23/2021 through 03/10/2021.701 CARTON0536-1211-95
D-0518-2021BENZOYL PEROXIDE WASH 5% 148ML; NDC/UPC 0536-1259-63; OTC; LIQUID; All Lots distributed 02/23/2021 through 03/10/2021.37 BOTTLE0536-1259-19, 0536-1259-63
D-0519-2021VITAMIN D3 50MCG 100 CALC; NDC/UPC 880681170007; OTC; TABLETS; All Lots distributed 02/23/2021 through 03/10/2021.427 BOTTLE—
D-0520-2021CARBIDOPA AND LEVORDOPA TABLETS, USP 25MG/100MG 100 TABLETS; NDC/UPC 51862-856-01; RX; TABLETS; FG12532407 BOXES—
D-0521-2021PEDIA-LAX 66ML; NDC/UPC 301320202205; OTC; ENEMA; All Lots distributed 02/23/2021 through 03/10/2021.147—
D-0522-2021Belsomra (suvorexant) tablets 10 mg Each tablet contains 10 mg suvorexant. This package contains 30 Tablets in 3 Blister Cards. Each Blister Card contains 10 Tablets Rx only NDC 00006-0033-30 Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc. Whitehouse Station, NJ 08889, USA; 1791139119 cartons—
D-0523-2021Belsomra (suvorexant) tablets 20 mg Each tablet contains 20 mg suvorexant. This package contains 30 Tablets in 3 Blister Cards. Each Blister Card contains 10 Tablets. Rx only NDC 0006-0335-30 Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc. Whitehouse Station, NJ 08880, USA; 1778598299 cartons0006-0005-10, 0006-0005-30, 0006-0005-13, 0006-0033-10, 0006-0033-30, 0006-0033-13, 0006-0325-10, 0006-0325-30, 0006-0325-13, 0006-0335-10, 0006-0335-30, 0006-0335-13
D-0524-2021Steglatro (ertugliflozin) tablets 15 mg 30 Tablets Rx only NDC 0006-5364-03 Manuf. for: Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Whitehouse Station, NJ 08889, USA; T013566215 bottles0006-5363-03, 0006-5363-08, 0006-5363-09, 0006-5363-06, 0006-5363-07, 0006-5363-10, 0006-5364-03, 0006-5364-08, 0006-5364-09, 0006-5364-06, 0006-5364-07
D-0525-2021ASMANEX TWST 220MCG 60INH PWD; NDC/UPC 85134102; RX; INHALER MEDICAL INTERNAL - MAY OR MAY NOT BE AEROSOL; T023471122 inhalers—
D-0526-2021Levothyroxine Sodium Tablets, USP 125 mcg (0.125 mg) 90 Tablets Rx only NDC 0378-1813-77 Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A.; 3109046112 bottles0378-1800-77, 0378-1800-10, 0378-1803-77, 0378-1803-10, 0378-1805-77, 0378-1805-10, 0378-1807-77, 0378-1807-10, 0378-1809-77, 0378-1809-10, 0378-1811-77, 0378-1811-10, 0378-1813-77, 0378-1813-10, 0378-1823-77, 0378-1823-10, 0378-1815-77, 0378-1815-10, 0378-1817-77, 0378-1817-10, 0378-1819-77, 0378-1819-10, 0378-1821-77
D-0527-2021Estradiol Transdermal System, USP 0.1 mg/day (Twice-Weekly) Delivers 0.1 mg/day Rx only NDC 0378-4623-26 Manufactured for: Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A.; 310820672 cartons0378-4619-16, 0378-4619-26, 0378-4620-16, 0378-4620-26, 0378-4621-16, 0378-4621-26, 0378-4622-16, 0378-4622-26, 0378-4623-16, 0378-4623-26
D-0528-2021Epinephrine Injection, USP Auto-Injectors in all strengths, packs and styles Manufactured for Mylan Specialty L.P., Morgantown, WV , NDC: 9502-500-01, 49502-500-02, 49502-500-92, 49502-501-01; 0FM544620 injector49502-500-01, 49502-500-02, 49502-500-92, 49502-501-01, 49502-501-02, 49502-501-92
D-0529-2021Proctofoam HC (hydrocortisone acetate 1% and pramoxine hydrochloride 1%) topical aerosol 10 g net wt Rx Only NDC 0037-6822-10 Distributed by: Meda Pharmaceutical Inc. Somerset, New Jersey; 33119834 aerosol containers0037-6822-10
D-0530-2021NAT B VIT D3 2000U 100; NDC/UPC 079854041125; OTC; TABLETS; All Lots distributed 02/23/2021 through 03/10/2021.47 bottles—
D-0531-2021Vitamin D3 Cholecalciferol 50,000 IU Dietary Supplement 100 Capsules NDC 75834-020-01 Marketed by: Nivagen Pharmaceuticals, Inc. Sacramento, CA 95827; All Lots distributed 02/23/2021 through 03/10/2021.523 bottles—
D-0532-2021Vitamin D3 Cholecalciferol 50,000 IU Dietary Supplement 12 Capsules NDC 75834-020-12 Marketed by: Nivagen Pharmaceuticals, Inc. Sacramento, CA 95827 USA; All Lots distributed 02/23/2021 through 03/10/2021.205 bottles—
D-0533-2021TOBREX 0.3% 3.5GM OPTH; NDC/UPC 65064435; RX; OINTMENT; 20B14E28 tubes—
D-0534-2021Ilevro (nepafenac ophthalmic suspension) 0.3% 3 mL Sterile Rx Only NDC 0065-1750-14 Alcon Laboratories, Inc. 6201 South Freeway Fort Worth, Texas 76134; 10CPE348 droptainers—
D-0535-2021CIPRODEX (CIPROFLOXACIN 0.3 AND DEXAMETHASONE 0.1%) 7.5ML; NDC/UPC 0078-0799-75; RX; DROPS; 20F02UA341 CARTON—
D-0536-2021Rybelsus (semaglutide) Tablets 7 mg Once daily Each tablet contains 7 mg semaglutide 30 tablets 3 blister packs. Each pack contains 10 tablets. Rx only NDC 0169-4307-13 Manufactured by: Novo Nordisk A/S DK-2880 Bagsvaerd, Denmark; K0823471189 cartons0169-1715-30, 0169-1715-90, 0169-1704-30, 0169-1709-30, 0169-4303-01, 0169-4303-13, 0169-4303-90, 0169-4303-93, 0169-4303-30, 0169-4303-99, 0169-4307-01, 0169-4307-13, 0169-4307-30, 0169-4314-01, 0169-4314-13, 0169-4314-30, 0169-4815-30, 0169-4815-90, 0169-4804-30, 0169-4809-30
D-0537-2021Benztropine Mesylate Tablets, USP in all pack sizes, styles and strengths Manufactured for: Qualitest Pharmaceuticals Huntsville, AL 35811; S200803160 bottles—
D-0538-2021Lamotrigine Extended-Release Tablets 250 mg 30 Tablets Rx Only NDC 49884-604-11 Manufactured by: Zhejiang Huahai Pharmaceutical Co., Ltd. Zhejiang 317024 China For Par Pharmaceutical Companes, Inc. Spring Valley, NY 10977 U.S.A.; 10116131 bottles49884-561-11, 49884-561-01, 49884-561-05, 49884-562-11, 49884-562-01, 49884-562-05, 49884-563-11, 49884-563-01, 49884-563-05, 49884-564-11, 49884-564-01, 49884-564-05, 49884-604-11, 49884-604-01, 49884-604-05, 49884-605-11, 49884-605-01, 49884-605-05
D-0539-2021ZOLPIDEM TARTRATE SUBLINGUAL TABLET 3.5 MG 30 UNIT DOSE POUCHES; NDC/UPC 49884089911; RX; EACH POUCH CONTAINS ONE SUBLINGUAL TABLET; 1269950155 Boxes—
D-0540-2021HySept Solution 0.25% Sodium Hypochlorite Solution 473 mL (16 fl. oz.) NDC 39328-063-25 Manufactured in USA Patrin Pharma, Skokie, IL 60076; All Lots distributed 02/23/2021 through 03/10/2021.236 bottles—
D-0541-2021RISPERIDONE 1MG/ML 30ML; NDC/UPC 50458059601; RX; SOLUTION (USUALLY NOT OTIC, OPTH, NASAL DROPS); KHB270139 bottles—
D-0542-2021Benzoyl Peroxide 2.5% Aqueous Base, Acne Treatment Gel Net Wt. 2.1 oz (60 g) NDC 45802-101-96 Distributed By Perrigo Allegan, MI 49010; All Lots distributed 02/23/2021 through 03/10/2021.5 tubes45802-101-96
D-0543-2021Benzoyl Peroxide 10% Acne Medication Wash Net Wt 5 oz (142 g) Distributed By Perrigo Allegan, MI 49010, NDC 45802-318-01; All Lots distributed 02/23/2021 through 03/10/2021.31 bottles45802-318-01, 45802-318-34
D-0544-2021Polyethylene Glycol 3350 Powder for Solution, Laxative Net Wt 4.1 oz (119 g) 7 Once-Daily Doses NDC 45802-868-01 Distributed by Perrigo Allegan, MI 49010; All Lots distributed 02/23/2021 through 03/10/2021.163 bottles45802-868-01, 45802-868-03, 45802-868-02, 45802-868-66
D-0545-2021POLYETHYLENE GLYCOL 3350 Powder for Solution Osmotic Laxative 14 once-daily doses 14 Packet- Newt Wt. 0.5 oz (17g) each NDC 45802-868-66; All Lots distributed 02/23/2021 through 03/10/2021.934 boxes45802-868-01, 45802-868-03, 45802-868-02, 45802-868-66
D-0546-2021Fexofenadine Hydrochloride Tablets, 180 mg Antihistamine Non-Drowsy 100 Tablets 180 mg Each NDC 45802-571-78 Distributed By Perrigo Allegan, MI 49010; All Lots distributed 02/23/2021 through 03/10/2021.321 bottles—
D-0547-2021LORATADINE 10MG 100 ND 24H; NDC/UPC 345802650788; OTC; TABLETS; All Lots distributed 02/23/2021 through 03/10/2021.2854 bottles—
D-0548-2021Cetirizine Hydrochloride Tablets, 10 mg, 300 Count; NDC/UPC 345802919878; OTC; TABLETS; All Lots distributed 02/23/2021 through 03/10/2021.1371 bottles—
D-0549-2021Podofilox Topical Solution 0.5% 3.5ML, Rx Only, For Topical Use Only, Manufactured by Perrigo, Minneapolis, MN 55427, NDC 0574-0611-05.; 402995180 bottles0574-0611-05
D-0550-2021HYDROCORTISONE ACET 30MG 12; RX; SUPPOSITORY,Rx Only, Distributed by: Perrigo, Allegan, MI 49010, NDC: 0574-7093-12; 43320295 suppositories0574-7090-12, 0574-7093-12
D-0551-2021Triamcinolone Acetonide Ointment, USP, 0.025% 80g; Rx Only, Distributed by: Perrigo, Allegan, MI 49010,NDC 45802-054-36; 0MT0286178 tubes45802-054-35, 45802-054-05, 45802-054-36, 45802-055-35, 45802-055-36, 45802-055-05, 45802-049-35
D-0552-2021LYRICA (pregabalin) capsules, 200mg 90-count bottle, Rx Only, Distributed by: Parke-Davis, Division of Pfizer Inc., NY, NY 10017, MADE IN SINGAPORE; CK108149 bottles—
D-0553-2021Methotrexate Injection, USP 50 mg/2mL (25 mg/mL) 5 x 2mL Single-Dose Vials, Sterile, Rx Only, Distributed by Hospira, Inc. Lake Forest, IL 60045. NDC 61703-350-38.; H074437AA341 vials61703-350-37, 61703-350-38, 61703-408-41
D-0554-2021Chantix (varenicline) Tablets Continuing Month Box Contains: 4 Continuing Weeks (1 mg x 56 tablets) Rx only NDC 0069-0469-03 Distributed by Pfizer Labs Division of Pfizer Inc., NY, NY 10017; EC5910940 cartons—
D-0555-2021Chantix (varenicline) Tablets Continuing Month Box Contains: 4 Continuing Weeks (1 mg x 56 tablets) Rx only ; Rx only Distributed by Pfizer Labs Division of Pfizer, Inc., NY, NY ,10017NDC 0069-0469-56; EM1069848 bottles0069-0468-56, 0069-0469-56, 0069-0469-28, 0069-0471-03, 0069-0471-28
D-0556-2021Chantix (varenicline) Tablets Starting Pack Contains: 1 Starting Week (0.5 mgx11 tablets) 3 Continuing Weeks (1 mgx42 tablets) Rx only NDC 0069-0471-03 Distributed by Pfizer Labs Division of Pfizer, Inc., NY, NY 10017; EC59111040 cartons0069-0468-56, 0069-0469-56, 0069-0469-28, 0069-0471-03, 0069-0471-28
D-0557-2021LEVOXYL Tablets, USD, 150MCG, 100-count bottle, Rx Only, Distributed by Pfizer Inc., New York, NY 10017, MADE IN AUSTRIA, NDC: 60793-858-01; 20D2713 bottles60793-850-10, 60793-850-01, 60793-851-10, 60793-851-01, 60793-852-10, 60793-852-01, 60793-853-10, 60793-853-01, 60793-854-10, 60793-854-01, 60793-855-10, 60793-855-01, 60793-856-10, 60793-856-01, 60793-857-10, 60793-857-01, 60793-858-10, 60793-858-01, 60793-859-10, 60793-859-01, 60793-860-10, 60793-860-01
D-0558-2021PROMETHAZINE PLAIN ORAL SOLUTION 6.25MG/5ML 473ML; ; RX; SOLUTION (USUALLY NOT OTIC, OPTH, NASAL DROPS), Rx Only, NDC 0211-0927-16; 2000148149 CARTON—
D-0559-2021Nature's Truth Absorbable Calcium 1200 mg plus D3 5000 IU 120 Softgels Dietary Supplements Carefully Designed and Distributed by Nature's Truth LLC. Ronkonkoma, NY 11779, UPC 840093100672; All Lots distributed 02/23/2021 through 03/10/2021.8 bottles—
D-0560-2021Intrarosa Prasterone Vaginal Inserts 6.5 mg 28 inserts/applicators Rx Only Manufactured for: Ednoceutics, Inc. Quebec City, Canada, G1V 4M7 Distributed by: AMAG Pharmaceuticals, Inc. Waltam, MA 02451, NDC 64011-601-28; R81339205 cartons—
D-0561-2021Budesonide and Formoterol Fumarate Dihydrate Inhalation Aerosol 80/4.5 budesonide 80 mcg/formoterol fumarate dihydrate 4.5 mcg Inhalation Aerosol 120 inhalations Rx only Manufactured for: AstraZeneca Pharmaceuticals LP, Wilmington, DE 19850, NDC 0310-7372-20; 2000655C00905 inhalers0310-7370-20, 0310-7372-20
D-0562-2021Medroxyprogesterone acetate injectable suspension, USP 150 mg per mL 1 mL Prefilled Syringe Rx only NDC 59762-4538-2 Distributed by: Greenstone, LLC. Peapack, NJ 07977; EC4744286 syringes—
D-0563-2021medroxyprogesterone acetate injectable suspension, USP, 150MG/ML 1ML, Rx Only, Distributed by: Greenstone LLC, Peapack, NJ 07977, NDC 59762-4538-02; DN0428148 syringes—
D-0564-2021Cefazolin for Injection, USP 1 gram per vial Rx Only Single-use Vial Sterile Manufactured in Austria by Sandoz GmbH for Sandoz, Inc., Princeton, NJ 08540, NDC 0781-3451-70; JZ98308 vials0781-3450-70, 0781-3450-95, 0781-3451-70, 0781-3451-96, 0781-3451-95
D-0565-2021HYDROCORTISONE 1% 30gm cream; KK4912143 tubes—
D-0566-2021Tuberculin Purified Protein Derivative (Mantous) TUBERSOL, Stabilized Solution 5 US Units, Rx Only Sanofi Pasteur Limited, NDC 49281-752-21; C5804AA406 vials49281-752-78, 49281-752-21, 49281-752-98, 49281-752-22
D-0567-2021Collagenase Santyl Ointment 250 units/g 30 grams Rx Only Marketed by Smith & Nephew, Inc., Fort Worth, TX 76107, NDC 50484-010-30; 1919601391 tubes50484-010-30, 50484-010-90
D-0568-2021CLINDAMYCIN HYDROCHLORIDE CAPSULES, USP,150MG 100-count bottles, Rx Only, Manufactured by: Ohm Laboratories Inc. New Brunswick, NJ 08901, Distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512, NDC 63304-692-01; AB77104223 bottles63304-692-01, 63304-692-05, 63304-692-77, 63304-692-03, 63304-693-16, 63304-693-01, 63304-693-03, 63304-693-05, 63304-693-77, 63304-693-11, 63304-693-62
D-0569-2021COREG CR (carvedilol phosphate) Extended Release Capsules, 80 mg, 30-count bottle, Rx Only,/UPC 57664066683; P0978133 bottles—
D-0570-2021Trokendi XR (topiramate) extended-release capsules 100 mg 30 Capsules Rx only, Manufactured by: Catalent Pharma Solutions Winchester, KY 40391 USA Manufactured for: Supernus Pharmaceuticals, Inc. Rockville, MD 20850 USA, NDC 17772-103-30; 1741214490 bottles17772-102-70, 17772-102-01, 17772-102-30, 17772-102-15, 17772-102-10, 17772-102-12, 17772-102-07, 17772-103-70, 17772-103-01, 17772-103-30, 17772-103-15, 17772-103-10, 17772-103-12, 17772-103-07, 17772-104-70, 17772-104-01, 17772-104-30, 17772-104-15, 17772-104-12, 17772-104-10, 17772-104-07, 17772-101-70, 17772-101-01, 17772-101-30, 17772-101-15, 17772-101-10, 17772-101-12, 17772-101-07
D-0571-2021Colcrys (colchicine, USP) tablets 0.6 mg 30 tablets Rx only Distributed by: Takeda Pharmaceuticals America, Inc. Deerfield, IL 60015,NDC 64764-119-07; 11888415160 bottles—
D-0572-2021Children's Loratadine Oral Solution USP, 5 mg/5 mL (Antihistamine) Allergy Grape Flavor 4 FL OZ (120 mL) NDC 51672-2131-8 Distributed by: Taro Pharmaceuticals U.S.A., Inc. Hawthorne, NY 10532; All Lots distributed 02/23/2021 through 03/10/2021.2907 bottles51672-2131-4, 51672-2131-8, 51672-2131-1
D-0573-2021Proair HFA (albuterol sulfate) Inhalation Aerosol 90 mcg per actuation With Dose Counter 200 Metered Inhalation 8,5 g Net Contents Rx only NDC 59310-579-22 Mktd by: Teva Respiratory, LLC Horsham, PA 19044 Mfd by: IVAX Pharmaceuticals Ireland Waterford, Ireland; DAF02A26895 inhalers—
D-0574-2021NEOMYCIN SULF TABLETS, USP, 500mg, 100-count bottle, Rx Only, Distributed by: Teva Pharmaceuticals USA, Inc., North Wales, PA 19454, NDC: 0093-1177-01; 300691041 bottles0093-1177-01
D-0575-2021BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE TABLETS 2.5 mg/6.25 mg, 100-count bottles, Rx Only, Distributed by: Teva Pharmaceuticals USA, Inc., Parsippany, NJ 07054 NDC 0093-3241-01 RX; TABLETS; 1417295A235 bottles0093-3241-01, 0093-3242-01, 0093-3243-56
D-0576-2021PENICILLIN V POT for Oral Solution, USP 125mg/5mL 100mL (when mixed) Rx Only, Manufactured for: Teva Pharmaceuticals USA, Inc., North Wales, PA 19454, NDC 0093-4125-73; 35446365A91 bottles0093-1172-01, 0093-1172-10, 0093-1174-01, 0093-1174-10, 0093-4125-73, 0093-4125-74, 0093-4127-73, 0093-4127-74
D-0577-2021EPINEPHRINE INJECTION USP, 0.3MG (AUTO-INJECTORS) FOR ALLERGIC EMERGENCIES (ANAPHYLAXIS) 2 Auto-Injectors and 1 Trainer, Manufactured for: Teva Pharmaceuticals USA, Inc., North Wales, PA 19454 NDC 0093-5986-27; 033J20AA414 boxes0093-5986-19, 0093-5986-27, 0093-5985-19, 0093-5985-27
D-0578-2021EPINEPHRINE INJECTION USP, 0.15 MG (AUTO-INJECTORS) FOR ALLERGIC EMERGENCIES (ANAPHYLAXIS) 2 Auto-Injectors and 1 Trainer, Manufactured for: Teva Pharmaceuticals USA, Inc., North Wales, PA 19454 NDC 0093-5985-27; 025C20AA1776 boxes0093-5986-19, 0093-5986-27, 0093-5985-19, 0093-5985-27
D-0579-2021Balziva 28 Day (norethindrone and ethinyl estradiol tablets USP) 6 Blister Card Dispensers, 28 tablets each, Rx Only, Manufactured for: Teva Pharmaceuticals USA, Inc., North Wales, PA 19454, NDC 0555-9034-58; 10001678523 bottles0555-9034-79, 0555-9034-58
D-0580-2021Levalbuterol tartrate HFA Inhalation Aerosol 45 mcg/actuation 200 Metered Inhalations Net Contents: 15 g Rx Only NDC 0591-2927-54 Distributed by: Actavis Pharma, Inc. Parsippany, NJ 07054 USA; 200093828 inhalers0591-2927-54
D-0581-2021Desvenlafaxine Extended-Release Tablets 25 mg 30 Tablets Rx Only NDC 0591-4060-30 Manufactured by: Actavis Laboratories FL, Inc. Fort Lauderdale, FL 33314 USA Distributed by: Actavis Pharma, Inc. Parsippany, NJ 07054 USA; 1399650A57 bottles0591-4060-30, 0591-3659-30, 0591-3660-30
D-0582-2021Sulindac Tablets, USP, 200mg 100-count bottles, Rx Only, Manufactured by: Epic Pharma, LLC, Laurelton, NY 11413, NDC 42806-011-01; 1578F20192 bottles42806-018-01, 42806-018-05, 42806-018-10, 42806-011-01, 42806-011-05, 42806-011-10
D-0583-2021Darifenacin Extended-release Tablets 7.5 mg 30 Tablets Rx only Manufactured by: Torrent Pharmaceuticals LTD. Indrad-382 721, India Manufactured for: Torrent Pharma Inc. Basking Ridge, NJ 07920, NDC 13668-202-30; BDZ7G00552 bottles13668-202-30, 13668-202-90, 13668-202-05, 13668-203-30, 13668-203-05, 13668-203-90
D-0584-2021Darifenacin Extended-release Tablets 15 mg 30 Tablets Rx only, Manufactured by: Torrent Pharmaceuticals, LTD Indrad-382 721, India Manufactured for: Torrent Pharma Inc. Basking Ridge, NJ 07920, NDC 13668-203-30; BDZ9G00537 bottles13668-202-30, 13668-202-90, 13668-202-05, 13668-203-30, 13668-203-05, 13668-203-90
D-0585-2021Folivane-Plus with Ascorbic Acid Precursors Iron/Folic Acid/Vitamin Supplement Capsules 90 Capsules Rx Only NDC 13811-539-90 Manufactured for: Trigen Laboratories, Inc., Sayreville, NJ 08872; All Lots distributed 02/23/2021 through 03/10/2021.80 bottles—
D-0586-2021TRAMADOL HYDROCHLORIDE TABLETS USP 100MG, 100-count bottle, Rx Only, Manufactured by: Rubicon Research :Private Limited, Ambernath, Dist. Thane, 421506 India, NDC: 52817-0196-10; 200340H186 BOTTLE—
D-0587-2021Restora Omega-3 enhanced Lactobacillus Casei KE-99 30 Capsules 1 A Day Nutritional Supplement NDC 52747-200-30 Marketed by US Pharmaceutical Corporation, P.O. Box 360465, Decatur, GA 30036; All Lots distributed 02/23/2021 through 03/10/2021.31 cartons—
D-0588-2021INTEGRA 325/40/3mg 90-count bottle, NDC: 52747-710-60; All Lots distributed 02/23/2021 through 03/10/2021.32 bottles—
D-0589-2021VIMPAT(lacosamide) Tablets ,100 mg, 60-count bottle; Rx Only, Manufactured for: UCB, Inc. Smyrna, GA 30080; 912056796 bottles—
D-0590-2021VIMPAT (lacosamide) Tablets, 200mg, 60-count bottle, Rx Only, Manufactured for: UCB, Inc. Smyrna, GA 30080, NDC 0131-2480-35; 912064882 bottles0131-2477-35, 0131-2477-60, 0131-2477-99, 0131-2478-35, 0131-2478-60, 0131-2478-99, 0131-2479-35, 0131-2479-60, 0131-2479-99, 0131-2480-35, 0131-2480-60, 0131-2480-99, 0131-1810-67, 0131-5410-70, 0131-5410-71, 0131-5410-72
D-0591-2021Briviact (brivaracetam) tablets 50 mg, 60-count bottle, Rx only Manufactured for UCB, Inc. Smyrna, GA 30080, NDC 50474-570-66; 309750101 bottles50474-470-66, 50474-470-09, 50474-470-14, 50474-370-66, 50474-570-66, 50474-570-09, 50474-570-14, 50474-670-66, 50474-770-66, 50474-770-09, 50474-770-14, 50474-870-15, 50474-970-63, 50474-970-75
D-0592-2021Amantadine Hydrochloride Tablets 100 mg 100-count bottle, Rx Only Manufactured by Upsher-Smith Laboratories, Inc. Maple Grove, MN 55369, NDC 0832-0111-00; 395310271 bottles0832-0111-00, 0832-0111-50, 0832-0111-89, 0832-0111-03
D-0593-2021HALOPERIDOL TABLETS 20mg, USP, 100-count bottle, Rx Only Distributed by: Usher-Smith Laboratories, LLC, Maple Grove, MN 55369, NDC: 0832-1560-11; 2007346C35 BOTTLE0832-1510-11, 0832-1520-11, 0832-1520-89, 0832-1520-01, 0832-1530-11, 0832-1540-11, 0832-1540-89, 0832-1540-01, 0832-1550-11, 0832-1550-89, 0832-1550-01, 0832-1560-11
D-0594-2021Corgard (nadolol tablets, USP) 40 mg 100 Tablets Rx only NDC 27505-101-01 Distributed by US WorldMeds, LLC, Louisville, KY 40241; 19T282 bottles—
D-0595-2021CYANOCOBAL Injection 1000MCG/ML 25X1ML; NDC/UPC 69680-112-25; RX; MULTI DOSE VIAL; 3038246 boxes69680-112-01, 69680-112-25, 69680-112-10, 69680-113-10, 69680-113-99, 69680-121-05, 69680-121-30, 69680-121-10
D-0596-2021Brompheniramine Maleate, Pseudoephedrine Hydrochloride and Dextromethorphan Hydrobromide Oral Syrup Net: 1 Pint (473 mL) Bulk Container-Not for Household Use Rx Only NDC 60432-275-16 Distributed By: Wockhardt USA, LLC Parsippany, NJ 07054; UV109215 bottles—
D-0597-2021Enalapril Maleate Tablets, USP 2.5 mg 100 tablets Rx only Distributed by: Cardinal Health, NDC 64679-923-02; DV1046710 bottles—
Based on the official FDA remedy

What to do — step by step

  1. Check Product Details

    Verify the NDC code 60631-080-30 on your Edarbi tablets.

✎ GovInfoNow

Questions people ask

Is this recall dangerous?

The recall is for potential temperature exposure during storage, which may affect drug stability. It is not immediately dangerous but requires checking the product.

How do I know if I have the recalled product?

Check for Edarbi 80mg tablets with NDC 60631-080-30. The product was manufactured for arbor Pharmaceuticals in Atlanta, GA.

What should I do if I have the recalled product?

The recall does not specify a remedy, so check with your healthcare provider or pharmacist for guidance.

Take action

Contact Cardinal Health

We’ve drafted a message you can send Cardinal Health to request your refund or repair — edit it as you like.

Subject: Recall D-0429-2021 — Cardinal Health Cardinal Health

Hello,

I own a Cardinal Health that is covered by recall D-0429-2021 from Cardinal Health.

I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this?

Thank you.

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Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

  • Official source: FDA Recall #D-0429-2021 (March 15, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0429-2021 to see it in context.
  • Plain-language summary written by qwen3:4b on October 4, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
  • GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA