AVKARE Inc. recalls
Every recall we track for AVKARE Inc. — 33 in all, from 2015–2022 — plus the complaints and injury reports the public filed about them.
Recalls per year, by danger level
Recalls from AVKARE Inc. peaked in 2019 (12); 31 since 2017.
All FDA recall records for AVKARE Inc. since 2017, counted by recall date (one bar per calendar year; 2026 is partial). Danger level is GovInfoNow’s plain-language rating; “not yet rated” records are still being written up.
| Year | Stop using now | Use caution | Lower risk | Not yet rated | Total |
|---|---|---|---|---|---|
| 2017 | 0 | 1 | 0 | 2 | 3 |
| 2018 | 0 | 0 | 2 | 5 | 7 |
| 2019 | 0 | 0 | 5 | 7 | 12 |
| 2020 | 0 | 0 | 6 | 1 | 7 |
| 2021 | 0 | 0 | 1 | 0 | 1 |
| 2022 | 0 | 0 | 0 | 1 | 1 |
| 2023 | 0 | 0 | 0 | 0 | 0 |
| 2024 | 0 | 0 | 0 | 0 | 0 |
| 2025 | 0 | 0 | 0 | 0 | 0 |
| 2026 (to date) | 0 | 0 | 0 | 0 | 0 |
AVKARE Inc. recalls before 2017
Recalls on record by year.
Most common reasons for AVKARE Inc. recalls
What to do if you have a recalled AVKARE Inc. product
- Match the NDC and lot number on your bottle or box to the recall.
- Don’t stop a prescription on your own — ask your pharmacist or doctor for a replacement first.
- Report side effects to FDA MedWatch.
All AVKARE Inc. recalls
22 shown- UnratedDrug
AVKARE Inc. recalls Lamotrigine Tablets, USP 100 mg, 1000-count bottles, Rx Only, Manufactured for: AvKARE, Inc. Pulaski, TN 38478, NDC
AvKare recalls 8,328 bottles of Lamotrigine Tablets USP 100 mg due to labeling errors regarding declared strength. Check your lot numbers.
AvKareJul 20, 2022 - Lower riskDrug
AVKARE Inc. recalls Phytonadione Tablets 5 mg, Rx Only, 30 Tablets (3x10) Unit Dose, Manufactured for: AvKARE Pulaski, TN 38478. NDC
AVKARE recalls 5mg Phytonadione tablets due to impurity levels exceeding specifications. This may affect safety for patients using prescription vitamin K.
AVKAREJun 9, 2021 - Lower riskDrug
AVKARE Inc. recalls TraZODONE Hydrochloride Tablets USP 100 mg, Rx Only, 1000-count Bottle, Manufactured for: AvKARE Pulaski, TN 38478, NDC
AVKARE recalls 1000-count TraZODONE Hydrochloride Tablets due to accidental packaging mix-up with sildenafil. Consumers should check product details and contact for safety.
AVKAREDec 7, 2020 - Lower riskDrug
AVKARE Inc. recalls Mesalamine Delayed-Release Tablets, USP 1.2 gram (Once-Daily), 120 Tablets bottle, Rx Only Manufactured for: AvKARE,
AVKARE recalls 120-tablet mesalamine delayed-release tablets (Rx only) due to failed dissolution specifications. This may affect tablets with NDC 42291-564-12 and specific expiration dates.
AVKAREOct 30, 2020 - Lower riskDrug
AVKARE Inc. recalls Metformin Hydrochloride Extended-Release Tablets, USP 500 mg, a) 50 count (NDC 50268-531-15); b) 90 count (NDC
AVKARE recalls Metformin Hydrochloride Extended-Release Tablets 500mg with N-Nitrosodimethylamine (NDMA) impurity above acceptable levels. FDA analysis detected this impurity in specific batch numbers and expiration dates.
AVKAREJun 4, 2020 - Lower riskDrug
AVKARE Inc. recalls Lamotrigine Tablets, USP, 150 mg, Rx Only, a) 60 count Bottle, NDC 42291-368-60, b) 500 count Bottle, NDC 42291-368-50,
AVKARE recalls 150mg Lamotrigine tablets (60 and 500 count bottles) due to foreign granules from desiccant packs. Consumers should check NDC numbers and lot dates.
AVKAREMay 28, 2020 - UnratedDrug
AVKARE Inc. recalls Dutasteride Capsules, 0.5 mg, 30 Capsules (6 X 5) Unit Dose per carton, Rx Only, Manufactured for: AvKARE, Inc.,
AVKARE recalls Dutasteride Capsules (0.5 mg) due to high impurities that could cause harm. Affected lots expired by Feb 2021. Consumers should contact pharmacy for advice.
AVKAREJan 7, 2020 - UnratedDrug
AVKARE Inc. recalls AVKARE Ranitidine Tablets, USP 150 mg Rx Only Manufactured for: AvKARE, Inc. Pulaski, TN 38478 Manufactured by: Amneal
AVKARE recalls 1000, 180, and 60-count ranitidine tablets with impurity N-nitrosodimethylamine (NDMA) that may pose health risks. Consumers should check NDC numbers and expiration dates.
AVKARENov 14, 2019 - Lower riskDrug
AVKARE Inc. recalls AVKARE Ranitidine Hydrochloride Capsules 150 mg 500 Capsules Rx Only NDC 42291-735-50 UPC 342291735507 Manufactured
AVKARE recalls 150mg ranitidine capsules due to N-nitrosodimethylamine (NDMA) impurity found in the active pharmaceutical ingredient.
AVKAREOct 17, 2019 - Lower riskDrug
AVKARE Inc. recalls AVKARE Fexofenadine Hydrochloride Tablets USP Antihistamine 180 mg, 500 Tablets per bottle, NDC 42291-297-50.
AVKARE recalls 500-tablet antihistamine bottles with failed stability specs. Products may degrade over time, causing potential safety issues. Check NDC 42291-297-50 and lot numbers for affected items.
AVKAREAug 28, 2019 - UnratedDrug
AVKARE Inc. recalls Losartan Potassium Tablets USP 50 mg 50 tablets (5x10) Unit Dose Rx Only NDC 50268-517-15 Manufactured for: AvKARE Inc.
FDA recalls AVKARE Losartan Potassium Tablets due to impurity NMBA above safe levels. Consumers should check NDC 50268-517-15 for affected units.
AVKAREApr 24, 2019 - UnratedDrug
AVKARE Inc. recalls Telmisartan and Amlodipine Tablets 80 mg/5 mg, 30 tablets, Rx Only, Manufactured for: AvKARE, Inc. Pulaski, TN 38478
AVKARE recalls 80mg/5mg Telmisartan and Amlodipine tablets (Rx only) due to potential impurities from long-term stability testing. These prescription blood pressure medications may pose safety risks if stored improperly.
AVKAREApr 3, 2019 - UnratedDrug
AVKARE Inc. recalls Losartan Potassium and Hydrochlorothiazide Tablets, USP 100 mg/12.5 mg 50 Tablets (5x10) Unit Dose boxes, Rx Only
AVKARE recalls 50-tablet unit dose boxes of losartan-hydrochlorothiazide tablets due to an impurity (NMBA) found during manufacturing. This could pose health risks to users.
AVKAREMar 5, 2019 - Lower riskDrug
AVKARE Inc. recalls Oxybutynin Chloride Extended-Release Tablets USP 10 mg, a) 100 tablets (NDC 42291-634-01) and b) 500 tablets (NDC
AVKARE recalls Oxybutynin Chloride Extended-Release Tablets USP 10 mg (100 and 500 tablets) due to failed dissolution specifications. These prescription-only tablets may not release medication properly.
AVKAREMar 1, 2019 - UnratedDrug
AVKARE Inc. recalls Germ Bloc Health Hand Sanitizer Foam (benzalkonium chloride 0.13%) 7.5fl.oz./222mL refill bags, AvKARE, Inc. Pulaski,
AvKARE recalls Germ Bloc Health Hand Sanitizer Foam refill bags due to Pseudomonas aeruginosa contamination. These bags may cause infections if used.
AvKARENov 20, 2018 - UnratedDrug
AVKARE Inc. recalls Valsartan Tablets, USP 40 mg Rx Only NDC 50268-783-15 50 Tablets (5x10) Unit Dose Manufactured for: AvKARE, Inc.
AVKARE recalls 40mg Valsartan tablets due to detected carcinogen impurity in manufacturing. Affected lots expire 10/2018 to 10/2019. No specific remedy provided in recall notice.
AVKAREAug 14, 2018 - Lower riskDrug
AVKARE Inc. recalls Amantadine HCl Capsules, USP, 100 mg, 50 Capsules (5x10) Unite Dose, Rx Only, Manufactured for: AvKARE Inc. Pulaski, TN
AVKARE recalls 100 mg Amantadine HCl Capsules (NDC 50268-069-15) due to failed dissolution specifications. This may affect medication effectiveness. Check your product details to determine if you are affected.
AVKAREMar 30, 2018 - Lower riskDrug
AVKARE Inc. recalls Lovastatin Tablets USP, 40 mg, 50 Tablets (5x10) Unit Dose carton, Rx only, Manufactured for AvKARE, Inc. Pulaski, TN
AVKARE recalls 40mg Lovastatin tablets with failed dissolution testing. Consumers should contact manufacturer for details.
AVKAREJan 3, 2018 - UnratedDrug
AVKARE Inc. recalls Duloxetine Delayed-release Capsules USP, 20 mg, 50 Capsules (5 x 10) Unit Dose per carton, unit dose blister UPC
AvKARE recalls specific lots of Duloxetine Delayed-release Capsules USP, 20 mg due to slightly elevated levels of phthalic acid impurities.
AvKAREOct 6, 2017 - UnratedDrug
AVKARE Inc. recalls Voriconazole Tablets, 200 mg, 20-count cartons (4 x 5) Unit Dose, Rx only, Manufactured for: AvKARE, Inc. Pulaski, TN
AvKARE recalls specific lots of Voriconazole Tablets 200 mg because they failed impurity specifications. Check your lot numbers and expiration dates for details.
AvKAREJul 19, 2017 - Use cautionDrug
AVKARE Inc. recalls Famciclovir tablets, 500 mg, packaged in 30-count unit dose cartons, Rx only, Manufactured for: AvKARE, Inc., Pulaski,
AvKARE recalls specific lots of Famciclovir tablets due to failed impurity specifications. Check your medication lot number and expiration date for details.
AvKAREFeb 15, 2017 - Use cautionDrug
AVKARE Inc. recalls Quinapril Tablets USP, 40 mg, Rx only, 50 tablets (5 X 10) unit dose pack, Manufactured for: AvKARE, Inc., Pulaski, TN
AvKare recalls specific lots of Quinapril Tablets USP, 40 mg due to subpotent drug concerns. Check your medication details below.
AvKareFeb 27, 2015
AVKARE Inc. recall questions
How many recalls has AVKARE Inc. had?
33 recalls from AVKARE Inc. are on record with U.S. safety agencies, from 2015–2022.
What is the most recent AVKARE Inc. recall?
AVKARE Inc. recalls Lamotrigine Tablets, USP 100 mg, 1000-count bottles, Rx Only, Manufactured for: AvKARE, Inc. Pulaski, TN 38478, NDC, dated Jul 20, 2022. Every AVKARE Inc. recall is listed on this page, newest first.
Why are AVKARE Inc. products recalled?
The most common reasons on record: Failed Dissolution Specifications (3); CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API (2); CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API (2); Subpotent Drug (2).
What should I do if I have a recalled AVKARE Inc. product?
Match the NDC and lot number on your bottle or box to the recall. Don’t stop a prescription on your own — ask your pharmacist or doctor for a replacement first. Report side effects to FDA MedWatch.
How do I get alerts for new AVKARE Inc. recalls?
Sign up for free email alerts on GovInfoNow — we check official CPSC, FDA, USDA and NHTSA data every day and email you only when a recall matches what you follow.