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Unrated Drug recall · FDA · Published January 24, 2022

Ultra Seal Recalls Pain & Sinus Reliever Packets Due to cGMP Deviations

Ultra Seal Corporation recalls 887,000 packets of Pain & Sinus Reliever due to current Good Manufacturing Practice deviations. Check your lot number.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #D-0497-2022DrugUltra Seal Corporation ›
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Contact the company

Recalling firmUltra Seal Corporation521 Main St · New Paltz, NY 12561-1609
✎ GovInfoNow plain-language explainer

Ultra Seal Corporation is recalling Pain & Sinus Reliever 2 tablet packets because they deviated from current Good Manufacturing Practices (cGMP). The product contains acetaminophen 500mg and Phenylephrine HCl 5mg. No specific injury mechanism or remedy was provided in the record. Read more at govinfonow.com/recall/35325-ultra-seal-recalls-pain-sinus-reliever-packets-due-to-cgmp.

Source Summary by GovInfoNow · govinfonow.com/recall/35325-ultra-seal-recalls-pain-sinus-reliever-packets-due-to-cgmp · Updated October 10, 2026 · FDA enforcement record: FDA #D-0497-2022

Cite this page

“Ultra Seal Recalls Pain & Sinus Reliever Packets Due to cGMP Deviations.” GovInfoNow, updated October 10, 2026. https://govinfonow.com/recall/35325-ultra-seal-recalls-pain-sinus-reliever-packets-due-to-cgmp. Based on FDA recall #D-0497-2022 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0497-2022%22&limit=1).

The FDA announced on Jan. 24, 2022, that Ultra Seal Corporation voluntarily recalled Pain & Sinus Reliever packets due to current Good Manufacturing Practice (cGMP) deviations. The recall affects 887,000 units distributed nationwide.

How to tell if you have it

  • Brand: Ultra Seal Corporation
  • Product: Pain & Sinus Reliever Packets
  • Description: Pain & Sinus Reliever Pain Reliever/Nasal Decongestant (acetaminophen 500mg, Phenylephrine HCl 5mg) 2 tablet packets
  • NDC: 67060-194-68
  • Lot #: AK9527
  • Exp. Date: 03/2022
  • Manufacturer for: Advanced First Aid, Baltimore, MD 21237

The hazard

The recall is due to cGMP deviations. The FDA classified the recall as Class II.

Context

GovInfoNow's records show Ultra Seal Corporation has two other recalls on record since Aug. 3, 2020. On Oct. 13, 2021, the company recalled ZEE+ Extra-Strength Pain Relief Tablets due to failed stability specifications for Salicylic Acid. Other recent recalls of similar products include Wells Pharma phenylephrine injectable solution (April 1, 2026), Ajanta Pharma Fenofibrate Capsules (May 28, 2026), and Wells Pharma Fentanyl Citrate Injectable Solution (April 1, 2026).

How to tell if you have this one

Look for Pain & Sinus Reliever 2 tablet packets with NDC 67060-194-68. Check the lot number AK9527 and expiration date 03/2022. The product was distributed nationwide within the United States.

  • Brand
    Ultra Seal Corporation
  • Category
    Drug
FDA recall event · 56 products

All 56 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
    Nationwide within the United States
Recall numberProduct, codes & lotsQuantityNDC
D-0464-2022Nasal & Sinus Decongestant (phenylephrine HCl 5mg) 2 tablets per packet, Mfd. for Cintas First Aid & Safety, Mason OH 45040; Lot #: AK9491, AK9496, Exp. Date 02/2022; K9817, Exp. Date 09/20223,508,200 packets—
D-0465-2022Cold Tablet Pain Reliever/Fever Reducer/Expectorant/Nasal Decongestant (acetaminophen 325 mg, Guaifenesin 200mg, Phenylephrine HCl 5 mg) 2 tablets per packet, Mfg, for Respond Industries and American First Aid, Mason, OH 45040; Lot #: K9824, Exp. Date 09/2022313,000 packets—
D-0466-2022AERO TAB Cold Relief (acetaminophen 325 mg, Guaifenesin 200mg, Phenylephrine HCl 5mg) 2 tablet packets, Mfg. for: Aero Healthcare, Valley Cottage, NY 10989; Lot #: AK9565, Exp. Date 04/2022226,390 packets—
D-0467-2022Maximum Strength Non Aspirin Pain Reliever/Fever Reducer (acetaminophen 500 mg) 2 tablet packets, Mfg. for: Advanced First Aid, Baltimore MD 21237, American Safety & First Aid, Osceola, IN 46561, NDC 67060-210-68; Lot #: AK9495, Exp. Date 02/2022; AK9613, Exp. Date 05/20221,236,000 packets—
D-0468-2022CHLORESIN (acetaminophen 325mg, dextromethorphan HBr 15mg, Guaifenesin 200mg, Phenylephrine HCl 5mg) 2 tablet packets, Manufactured For Afassco Inc. Minden NV 89423, NDC 51532-0107-2; Lot #: AK9492, Exp. Date 02/2022225,350 packets—
D-0469-2022Extra Strength (ES) PAIN RELIEVER (acetaminophen 500 mg) 2 tablet packets, Manufactured by Ultratab Laboratories, Inc.; Lot #: AK9602, Exp. Date 05/2022297,050 packets—
D-0470-2022Legatrin PM Pain Reliever/Sleep Aid (acetaminophen 500 mg, diphenhydramine HCl 50mg caplets) 50-count bottles, Manufactured for: Church & Dwight Co., Inc. Ewing, NJ 08628 NDC 10237-907-50; Lot #: HY9042, Exp. Date 02/2022; HY9094, HY9112, Exp. Date 04/2022; HY9134, Exp. Date 05/2022; HY9267, Exp. Date 09/2022174,852 bottles—
D-0471-2022Cystex Urinary Pan Relief (NSAID) (methenamine 162mg, sodium salicylate 162.5mg tablets) packaged in a) 40-count blisters and b) 20-count blisters, Distributed by: Clarion Brands, LLC 27070 Miles Road, Suite A Solon, OH 44139, NDC 69693-512-40; Lot #: a) 19A043, 19A093, Exp. Date 01/2022; 19B062,19C079,19C080, Exp. Date 03/2022; 19D041, Exp. Date 04/2022; 19E035, 19E087, Exp. Date 05/2022; 19G084, Exp. Date 08/2022; 19H098, Exp. Date 09/2022 b) 19H098A, Exp. Date 09/2022a) 702,240 blisters, b) 30,180 blisters69693-512-40, 69693-512-20, 69693-512-24, 69693-512-48
D-0472-2022DBI 357 Super Magnum Quick Energy Stimulant (caffeine 200mg) tablets, packaged in a) 36-count bottles, b) 100-count bottles, c) 500-count bottles, and d) 3-count packets, Marketed by: DBI Distribution A Division of King Richard Promotions, Inc. P.O. Box 78546, Indianapolis, IN 46270; Lot #: a) C19065, Exp. Date 03/2022; F19081, Exp. Date 06/2022; 19H083, Exp. Date 08/2022; b) H19083, 1H9083, Exp. Date 08/2022; c) 19F081, Exp. Date 06/2022; 19083H, Exp. Date 08/2022; d) 19C065, Exp. Date 03/2022; 19081F, Exp. Date 06/2022a) 147,528 bottles, b) 2,451 bottles, c) 2,492 bottles, d) 573,696 packets—
D-0473-2022Ephedrine Plus (Ephedrine HCl 25mg, Guaifenesin 200mg) tablets, 24-count bottles, Marketed by: DMD Pharmaceuticals A Division of Dickery Consumer Products, Inc. Noblesville, IN 46060, NDC 65193-320-24; Lot#: 18M063, Exp. Date 01/2022; 19G076, Exp. Date 09/2022301,842 bottles—
D-0474-2022Dologen (acetaminophen 325 mg and dexbrompheniramine maleate 1mg) caplets, packaged in a) 90-count bottles, b) 2-count packets, Manufactured in the USA for Kramer-Novis, San Juan, Puerto Rico 00917, NDC 52083-482-02; Lot #: a) 19G074, 19G075, Exp. Date 07/2022; b) 19G075, Exp. Date 07/2022a) 9,060 bottles, b) 44,700 packets—
D-0475-2022MidNite Sleep Health (melatonin 1.5 mg) tablets, 30-count bottles, Distributed by: Mylan Consumer Healthcare, Inc. Morgantown, WV 26505 USA; Lot #: 18L124, 18L125, 18L126, Exp. Date 02/2022; 19C037, 19C038, 19C039, 19C040, Exp. Date 03/2022; 19D029, 19D030, Exp. Date 04/2022; 19D031, Exp. Date 06/2022; 19G047, Exp. Date 07/20222,189,232 bottles—
D-0476-2022Back Pain-Off (caffeine 50mg, magnesium salicylate 290mg) Tablets 2-count packets, Mfd for MEDIQUE PRODUCTS, Fort Myers, FL 33967, NDC 47682-073-00; Lot #: 9708, Exp. Date 07/2022; AK9810, Exp. Date 09/2022; AK9946, K9946, Exp. Date 12/20221,959,267 packets—
D-0477-2022Cetafen Non-aspirin pain reliever (acetaminophen 325mg) tablets, 2-count packets, Manufactured for: HARTHealth Seattle, WA 98124; Lot #: A-K-9668, Exp. Date 06/2022; A-K-9475, Exp. Date 02/2022915,770 packets—
D-0478-2022Multi Symptom Cold Relief (acetaminophen 325 mg, Dextromethorphan HBr 15mg, Guaifenesin 200mg, Phenylephrine HCl 5mg) tablets, 2-count packets, Dist. by Honeywell Safety Products USA, Smithfield, RI 02917; Lot #: AK9715, K9715, Exp. Date 07/2022673,160 packets—
D-0479-2022Lite Remfresh Advanced Ion-Powered Melatonin (Melatonin 0.5mg) Tablets, 36-count blisters, Physician's Seal LLC, Boca Raton, FL 33487; Lot #: 19E058A, 19E058B, Exp. Date 05/202225,776 blisters—
D-0480-2022Cold Relief Severe Pain/Cough (acetaminophen 325mg, Dextromethorphan HBr 15mg, Guaifenesin 200mg, phenylephrine HCl 5mg), 2-tablet packets, Manufactured for Select Corporation, Carrollton, TX 75007; Lot #: AK9436, Exp. Date 01/2022227,010 packets—
D-0481-2022Multi-Symptom Cramp Relief (acetaminophen 325mg and Pamabrom 25mg), 2- tablet packets, Mfd. for First Aid Direct, Mason, OH 45040; Lot #: AK9453, Exp. Date 01/2022; AK9716, 07/20221,351,660 packets—
D-0482-2022Backache & Muscle Relief (acetaminophen 250 mg, magnesium salicylate-tetrahydrate 290mg, caffeine 50 mg) 2 tablets per packet, Mfd. for First Aid Direct, Mason, OH 45040, NDC 42961-111-832; Lot #: K9770, AK9770 Exp. Date 08/2022; AK9958, K9958 Exp. Date 12/2022; AK9717, Exp. Date 07/2022; AK9522, AK9641 , Exp. Date 03/2022; AK9817, Exp. Date 09/20225,107,565 packets—
D-0483-2022Cold Relief (acetaminophen 250 mg, guaifenesin 200mg, phenylephrine HCl 5 mg) 2 tablets per packet, Mfd. for First Aid Direct, Mason, OH 45040, NDC 42961-112-03; Lot #: K9456, AK9454, 9456, AK9456, Exp. Date 01/2022; AK9524, AK9528 Exp. Date 03/2022; K9767, AK9767, Exp. Date 08/2022; AK9824, AK9823, Exp. Date 09/2022; AK9564, Exp. Date 04/20227,858,690 packets—
D-0484-2022Headache & Congestion Sinus Relief (acetaminophen 250 mg, phenylephrine HCl 5 mg) 2 tablets per packet, Mfd. for First Aid Direct, Mason, OH 45040, NDC 42961-0206-02; Lot #: 9445, AK9445, K9445, Exp. Date 01/2022; K9486, Exp. Date 02/2022; AK9708, Exp. Date 07/2022; AK9515, Exp. Date 03/2022; K9810, Exp. Date 09/2022; AK9658, Exp. Date 06/20225,741,384 packets—
D-0485-2022Pain Away Pain Reliever/Fever Reducer (NSAID) (acetaminophen 110 mg, aspirin 162 mg, salicylamide 152mg, caffeine 32.4 mg), 2 tablets per packet, Mfg, for Respond Industries and American First Aid, Mason, OH 45040; Lot #: AK9493, Exp. Date 02/20221,186,000 packets—
D-0486-2022Cold/Sinus Pain Reliever/Fever Reducer Nasal Decongestant (acetaminophen 325 mg, Phenylephrine HCl 5mg), 2 tablets per packet, Mfg, for Respond Industries and American First Aid, Mason, OH 45040; Lot #: K9708, Exp. Date 07/2022301,650 packets—
D-0487-2022COLD TERMINATOR decongestant/cold relief (acetaminophen 325 mg, Guaifenesin 200mg, 5.0 Phenylephrine HCl) 2 tablet packets, Manufactured for: Tellus Medical Products, Carlsbad, CA 92011, NDC 69103-2556; Lot #: AK9587, Exp. Date 02/2022226,400 packets—
D-0488-2022PAIN TERMINATOR extra strength pain relief (aspirin 162 mg, acetaminophen 110 mg, Caffeine 32.4mg, Salicylamide 152 mg) 2 tablet packets, Manufactured for: Tellus Medical Products, Palm Desert, CA 92211, NDC 69103-2507; Lot #: AK9451, Exp. Date 01/20221,188,280 packets—
D-0489-2022SINU-PHEN PLUS sinus pain and congestion tabs (acetaminophen 500 mg, Phenylephrine HCl 5.0 mg) 2 tablet packets, Manufactured for: Tellus Medical Products, Palm Desert, CA 92211, NDC 69103-2536-00; Lot #: AK9766, Exp. Date 08/2022122,400 packets—
D-0490-2022DILOTAB II, SINUS AND COLD RELIEF NON DROWSY (acetaminophen 325 mg, Phenylephrine HCl 5 mg) 2 tablet packets, Dist. by ZEE Medical Distributors, LLC Mason, OH 45040, NDC 42961-052-03; Lot #: AK9548, (L) 106, Exp. Date 04/2022; AK9647, (L)103, Exp. Date 06/2022; AK9598, Exp. Date 05/20222,685,700 packets—
D-0491-2022EXTRA STRENGTH UN-ASPIRIN (acetaminophen 500 mg) 2 Caplet packets, Dist. by ZEE Medical Distributors, LLC Mason, OH 45040, NDC 42961-041-03; Lot #: AK9599, Exp. Date 05/2022; AK9648, (L) 104, Exp. Date 06/20221,694,200 packets—
D-0492-2022PAINAID (acetaminophen 110 mg, aspirin 162mg, caffeine 32.4 mg, salicylamide 152mg) 2 tablet packets, Dist. by ZEE Medical Distributors, LLC Mason, OH 45040; Lot #: AK9433, Exp. Date 01/2022; AK9749, Exp. Date 08/20222,336,600 packets—
D-0493-2022PAINAID BRF Back Relief Formula (acetaminophen 250 mg, caffeine 50 mg, Magnesium salicylate 290 mg) 2 tablet packets, Dist. by ZEE Medical Distributors, LLC Mason, OH 45040, NDC 42961-0003-00; Lot #: AK9698, Exp. Date 07/2022111,300 packets—
D-0494-2022PAINAID PMF Premenstrual Formula (acetaminophen 500 mg, pamabrom 25mg) 2 caplet packets, Dist. by ZEE Medical Distributors, LLC Mason, OH 45040, NDC 42961-0046-03; Lot #: AK9434, (L)101, Exp. date 01/2022769,200 packets—
D-0495-2022CONGESTAID II Nasal Decongestant (Phenylephrine HCl 5mg) 2 tablet packets, Dist. by ZEE Medical Distributors, LLC Mason, OH 45040; Lot #: AK9478, Exp. Date 02/2022; AK9799, Exp. Date 09/2022447,050 packets—
D-0496-2022Mint Flavored Antacid (Calcium Carbonate 420mg) 2 tablet packets, Mfg for Just American Safety, Osceola, IN 46561, NDC 67060-303-68; Lot #: AK9523, K9523 Exp. Date 03/2022; AK9670, Exp. Date 06/20221,309,800 packets—
D-0497-2022Pain & Sinus Reliever Pain Reliever/Nasal Decongestant (acetaminophen 500mg, Phenylephrine HCl 5mg) 2 tablet packets, Mfg for Advanced First Aid, Baltimore, MD 21237, NDC 67060-194-68; Lot #: AK9527, Exp. Date 03/2022887,000 packets—
D-0498-2022Regular Strength Pain Reliever (acetaminophen 110 mg, aspirin 162 mg, Caffeine 32.4 mg, Salicylamide 152 mg) 2 tablet packets, Mfg for Advanced First Aid, Baltimore, MD 21237, NDC 67060-0113-00; Lot #: AK9450, Exp. Date 01/20221,180,000 packets—
D-0499-2022PAPENOL (acetaminophen 500 mg), 2 tablet packets, Manufactured for: Afassco Inc. Minden, NV 89423; Lot #: K9495, Exp. Date 02/2022; AK9614, Exp. Date 05/2022533,100 packets—
D-0500-2022MAGNACAL (calcium carbonate 420 mg), 2 tablet packets, Manufactured for: Afassco Inc. Minden, NV 89423; Lot #: AK9768, Exp. Date 08/2022307,000 packets—
D-0501-2022PEPTIME Energy (caffeine 250mg) tablets, 100-count bottles, Marketed by: DMD Pharmaceuticals, A Division of Dickery Consumer Products, Inc., Noblesville, IN 46060.; Lot #: 19E021, 19E022N/A—
D-0502-2022PEPTIME Energy (caffeine 300mg) tablets, packaged in a) 6 count packets and b) 100-count bottles, Marketed by: DMD Pharmaceuticals, A Division of Dickery Consumer Products, Inc., Noblesville, IN 46060.; Lot #: a)19E030, b)19E031a)131,112 packets, b) 8,064 bottles—
D-0503-2022PEPTIME Energy (caffeine 350mg) tablets, packaged in a) 6 count packets and b) 100-count bottles, Marketed by: DMD Pharmaceuticals, A Division of Dickery Consumer Products, Inc., Noblesville, IN 46060.; Lot #: a)19E032, b)19E033a) 113,040 packets, b) 7,132 bottles—
D-0504-2022PEPTIME Energy (caffeine 250mg) tablets, packaged in a) 6 count packets and b) 100-count bottles, Marketed by: DMD Pharmaceuticals, A Division of Dickery Consumer Products, Inc., Noblesville, IN 46060.; Lot #: a)19E021, b)19E022a) 156,096 packets, b) 9,648 bottles—
D-0505-2022CVS Health Natural Sleep Aid Chewable Tablets Cherry Flavor (melatonin 1.5mg), 30-count bottles, Distributed by: CVS Pharmacy Inc. One CVS Drive, Woonsocket, RI 02895; Lot #: 18L124, Exp. Date 02/2022; 19D029, Exp. Date 04/2022241,560 bottles—
D-0506-2022MidNite Natural sleep aid Chewable Tablets Cherry Flavor (melatonin 1.5mg), 30-count bottles, BGP Pharma ULC, Etobicoke, ON M8Z 2S6; Lot #: 19C038C, Exp. Date 03/2022; 19G047C, Exp. Date 07/2022; 18L124C, Exp. Date 02/202290,072 bottles—
D-0507-2022Exaprin pain reliever (acetaminophen 110 mg, aspirin 162 mg, caffeine 32.4mg, salicylamide 152mg) tablets, 2- tablet packets, Manufactured for: HARTHealth Seattle, WA 98124; Lot #: AK9796, Exp. Date 09/20221,1401,641 packets—
D-0508-2022Nutralox Mint Antacid (calcium carbonate 420mg) Chewable tablets, 2-count packets, Manufactured for: HARTHealth Seattle, WA 98124; Lot #: AK9566, Exp. Date 04/2022; AK9612, Exp. Date 05/20221,486,050 packets—
D-0509-2022FEM-PRIN MENSTRUAL RELIEF (acetaminophen 325 mg, pamabrom 25mg) tablets, 2-count packets, Manufactured for: HARTHealth Seattle, WA 98124; Lot #: AK9695, Exp. Date 07/2022223,090 packets—
D-0510-2022CETAFEN COUGH & COLD COUGH & COLD RELIEF (Acetaminophen 325 mg, Dextromethorphan HBr 15mg, Guaifenesin 200mg, phenylephrine HCl 5mg) Coated tablets, 2-count packets, Manufactured for: HARTHealth Seattle, WA 98124; Lot #: AK9841, Ex. Date 10/2022225,000 packets—
D-0511-2022CETAFEN Extra Non-Aspirin Pain Relieve (Acetaminophen 500 mg) caplets, 2-count packets, Manufactured for: HARTHealth Seattle, WA 98124; Lot #: AK9475, Exp. Date 02/20221,019,000 packets—
D-0512-2022AYPANAL Non-aspirin Pain Reliever (acetaminophen 325 mg) tablets, 2-count packets, Dist. by Honeywell Safety Products USA, Smithfield, RI 02917; Lot #: AK9640, Exp. Date 03/2022216,000 packets—
D-0513-2022SINUS DECONGESTANT Nasal Decongestant (phenylephrine HCl 5mg) tablets, 2-count packets, Dist. by Honeywell Safety Products USA, Smithfield, RI 02917; Lot #: AK9859, Exp. Date 10/2022448,300 packets—
D-0514-2022MIRALAC (calcium carbonate 420mg) tablets, Mint Flavor, 2-count packets, Dist. by Honeywell Safety Products USA, Smithfield, RI 02917; Lot #: AK9486, Exp. Date 02/2022409,890 packets—
D-0515-2022ELECTROLYTE Supplement Tablets (calcium 5.2 mg, Potassium 20.8 mg, Magnesium 6 mg ) 2-count packets, Dist. by Honeywell Safety Products USA, Smithfield, RI 02917; Lot #: AK9797, AK92541,474,050 packets—
D-0516-2022REMfresh Advanced Ion-Powered Melatonin (Melatonin 2 mg) Caplets, packaged in a) 12-count blisters b) 36-count blisters Physician's Seal LLC, Boca Raton, FL 33487; Lot #: a) 19B050A, 19B050B, 19B050C, 19B050D, 19B050E, Exp. Date 06/2022; 19F063, 19F063A, 19F063B, Exp. Date 08/2022; b) 19B050-A, Exp. Date 06/2022a) 308,928 blisters b) 29,808 blisters—
D-0517-2022REMfresh Advanced Ion-Powered Melatonin (Melatonin 5 mg) Caplets, packaged in 36-count blisters Physician's Seal LLC, Boca Raton, FL 33487; Lot #: 19B011, 19B012, 19B012A, 19E023, Exp. Date 05/202240,344 blisters—
D-0518-2022Sinus Relief (acetaminophen 325mg, Guaifenesin 200mg, phenylephrine HCl 5mg), 2-tablet packets, Manufactured for Select Corporation, Carrollton, TX 75007; Lot #: AK9651, Exp. Date 06/2022; AK9437, Exp. Date 01/2022447,190 packets—
D-0519-2022Sinus Relief Headache/Nasal (acetaminophen 325mg, phenylephrine HCl 5mg), 2 tablet packets, Manufactured for Select Corporation, Carrollton, TX 75007; Lot #: AK9436, Exp. Date 01/2022227,010 packets—

Where it went and when

Where it was distributed

Distributed nationwide.

Alaska: yesAKMaine: yesMEVermont: yesVTNew Hampshire: yesNHWashington: yesWAIdaho: yesIDMontana: yesMTNorth Dakota: yesNDMinnesota: yesMNIllinois: yesILWisconsin: yesWIMichigan: yesMINew York: yesNYRhode Island: yesRIMassachusetts: yesMAOregon: yesORNevada: yesNVWyoming: yesWYSouth Dakota: yesSDIowa: yesIAIndiana: yesINOhio: yesOHPennsylvania: yesPANew Jersey: yesNJConnecticut: yesCTCalifornia: yesCAUtah: yesUTColorado: yesCONebraska: yesNEMissouri: yesMOKentucky: yesKYWest Virginia: yesWVVirginia: yesVAMaryland: yesMDDelaware: yesDEArizona: yesAZNew Mexico: yesNMKansas: yesKSArkansas: yesARTennessee: yesTNNorth Carolina: yesNCSouth Carolina: yesSCDistrict of Columbia: yesDCOklahoma: yesOKLouisiana: yesLAMississippi: yesMSAlabama: yesALGeorgia: yesGAHawaii: yesHITexas: yesTXFlorida: yesFL

FDA distribution: “Nationwide within the United States” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide.

Recall timeline

FDA terminated this recall 21 months after the firm started it.

1. Firm started the recall: Jan 24, 202212. FDA classified it Class II: Jan 31, 202223. Published in FDA’s Enforcement Report: Feb 9, 202234. FDA terminated the recall: Oct 16, 2023420222023
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report
  4. FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

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Keep exploring

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-0497-2022 (January 24, 2022) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0497-2022 to see it in context.
  • Plain-language summary written by qwen3.6:35b-a3b on October 10, 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