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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Drug
Medications & Supplements

Various CVS, REMfresh, and Other Medications Recalled for Manufacturing Issues

Agency Publication Date: January 31, 2022
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Summary

Ultra Seal Corporation is recalling 67,135,079 units of several over-the-counter medications and dietary supplements including REMfresh (melatonin), CVS Health Natural Sleep Aid (melatonin), Legatrin PM (acetaminophen and diphenhydramine), and various sinus and pain relievers. The recall was initiated because the products were not manufactured in compliance with quality control standards (cGMP deviations), which means their safety, strength, and purity cannot be guaranteed. Affected products were distributed nationwide in various blister packs and bottles. No injuries or illnesses have been reported in connection with this recall.

Risk

The lack of proper manufacturing quality controls means these products may not contain the correct amount of active ingredients or could be contaminated. Using medications that do not meet quality standards can lead to ineffective treatment or unexpected health reactions.

What You Should Do

  1. This recall affects dozens of brand-name medications and supplements including REMfresh, CVS Health, MidNite, PainAid, Cetafen, Sinus Relief, and others sold in bottles, blister packs, and individual packets.
  2. Identify if your product is affected by checking the brand name, dosage, and package size against the lists provided. See the Affected Products section below for the full list of affected codes.
  3. If you have health concerns, contact your healthcare provider or pharmacist. Return any unused product to the place of purchase for a refund, throw it away, or contact the manufacturer for further instructions.
  4. Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional questions regarding this safety alert.

Your Remedy Options

You have 2 options:

๐Ÿ’ฐOption 1: Full Refund
How to: Contact your healthcare provider or pharmacist for guidance, or return any unused product to the place of purchase for a refund
๐Ÿ—‘๏ธOption 2: Dispose of Product
How to: Throw the product away. For prescription medications, a DEA take-back location or pharmacy mail-back program is preferred when available.

Affected Products

Product: REMfresh Advanced Ion-Powered Melatonin (2 mg)by REMfresh
Variants: Caplets, 12-count blisters, 36-count blisters
Lot Numbers:
19B050A (Exp 06/2022)
19B050B (Exp 06/2022)
19B050C (Exp 06/2022)
19B050D (Exp 06/2022)
19B050E (Exp 06/2022)
19F063 (Exp 08/2022)
19F063A (Exp 08/2022)
19F063B (Exp 08/2022)
19B050-A (Exp 06/2022)
Product: REMfresh Advanced Ion-Powered Melatonin (5 mg)by REMfresh
Variants: Caplets, 36-count blisters
Lot Numbers:
19B011 (Exp 05/2022)
19B012 (Exp 05/2022)
19B012A (Exp 05/2022)
19E023 (Exp 05/2022)
Product: Sinus Relief (acetaminophen 325mg, Guaifenesin 200mg, phenylephrine HCl 5mg)by Select Corporation
Variants: 2-tablet packets
Lot Numbers:
AK9651 (Exp 06/2022)
AK9437 (Exp 01/2022)
Product: Sinus Relief Headache/Nasal (acetaminophen 325mg, phenylephrine HCl 5mg)by Select Corporation
Variants: 2 tablet packets
Lot Numbers:
AK9436 (Exp 01/2022)
Product: Nasal & Sinus Decongestant (phenylephrine HCl 5mg)by Cintas First Aid & Safety
Variants: 2 tablets per packet
Lot Numbers:
AK9491 (Exp 02/2022)
AK9496 (Exp 02/2022)
K9817 (Exp 09/2022)
Product: Cold Tablet Pain Reliever/Fever Reducer/Expectorant/Nasal Decongestant (acetaminophen 325 mg, Guaifenesin 200mg, Phenylephrine HCl 5 mg)by Respond Industries / American First Aid
Variants: 2 tablets per packet
Lot Numbers:
K9824 (Exp 09/2022)
Product: AERO TAB Cold Relief (acetaminophen 325 mg, Guaifenesin 200mg, Phenylephrine HCl 5mg)by Aero Healthcare
Variants: 2 tablet packets
Lot Numbers:
AK9565 (Exp 04/2022)
Product: Maximum Strength Non Aspirin Pain Reliever/Fever Reducer (acetaminophen 500 mg)by Advanced First Aid / American Safety & First Aid
Variants: 2 tablet packets
Lot Numbers:
AK9495 (Exp 02/2022)
AK9613 (Exp 05/2022)
NDC:
67060-210-68
Product: CHLORESIN (acetaminophen 325mg, dextromethorphan HBr 15mg, Guaifenesin 200mg, Phenylephrine HCl 5mg)by Afassco Inc.
Variants: 2 tablet packets
Lot Numbers:
AK9492 (Exp 02/2022)
NDC:
51532-0107-2
Product: Extra Strength (ES) PAIN RELIEVER (acetaminophen 500 mg)by Ultratab Laboratories, Inc.
Variants: 2 tablet packets
Lot Numbers:
AK9602 (Exp 05/2022)
Product: Legatrin PM Pain Reliever/Sleep Aid (acetaminophen 500 mg, diphenhydramine HCl 50mg)by Church & Dwight Co., Inc.
Variants: Caplets, 50-count bottles
Lot Numbers:
HY9042 (Exp 02/2022)
HY9094 (Exp 04/2022)
HY9112 (Exp 04/2022)
HY9134 (Exp 05/2022)
HY9267 (Exp 09/2022)
NDC:
10237-907-50
Product: DILOTAB II, SINUS AND COLD RELIEF NON DROWSY (acetaminophen 325 mg, Phenylephrine HCl 5 mg)by ZEE Medical Distributors, LLC
Variants: 2 tablet packets
Lot Numbers:
AK9548 (Exp 04/2022)
AK9647 (Exp 06/2022)
AK9598 (Exp 05/2022)
NDC:
42961-052-03
Product: EXTRA STRENGTH UN-ASPIRIN (acetaminophen 500 mg)by ZEE Medical Distributors, LLC
Variants: 2 Caplet packets
Lot Numbers:
AK9599 (Exp 05/2022)
AK9648 (Exp 06/2022)
NDC:
42961-041-03
Product: PAINAID (acetaminophen 110 mg, aspirin 162mg, caffeine 32.4 mg, salicylamide 152mg)by ZEE Medical Distributors, LLC
Variants: 2 tablet packets
Lot Numbers:
AK9433 (Exp 01/2022)
AK9749 (Exp 08/2022)
Product: PAINAID BRF Back Relief Formula (acetaminophen 250 mg, caffeine 50 mg, Magnesium salicylate 290 mg)by ZEE Medical Distributors, LLC
Variants: 2 tablet packets
Lot Numbers:
AK9698 (Exp 07/2022)
NDC:
42961-0003-00
Product: PAINAID PMF Premenstrual Formula (acetaminophen 500 mg, pamabrom 25mg)by ZEE Medical Distributors, LLC
Variants: 2 caplet packets
Lot Numbers:
AK9434 (Exp 01/2022)
NDC:
42961-0046-03
Product: CONGESTAID II Nasal Decongestant (Phenylephrine HCl 5mg)by ZEE Medical Distributors, LLC
Variants: 2 tablet packets
Lot Numbers:
AK9478 (Exp 02/2022)
AK9799 (Exp 09/2022)
Product: Mint Flavored Antacid (Calcium Carbonate 420mg)by Just American Safety
Variants: 2 tablet packets
Lot Numbers:
AK9523 (Exp 03/2022)
K9523 (Exp 03/2022)
AK9670 (Exp 06/2022)
NDC:
67060-303-68
Product: Pain & Sinus Reliever Pain Reliever/Nasal Decongestant (acetaminophen 500mg, Phenylephrine HCl 5mg)by Advanced First Aid
Variants: 2 tablet packets
Lot Numbers:
AK9527 (Exp 03/2022)
NDC:
67060-194-68
Product: Regular Strength Pain Reliever (acetaminophen 110 mg, aspirin 162 mg, Caffeine 32.4 mg, Salicylamide 152 mg)by Advanced First Aid
Variants: 2 tablet packets
Lot Numbers:
AK9450 (Exp 01/2022)
NDC:
67060-0113-00
Product: PAPENOL (acetaminophen 500 mg)by Afassco Inc.
Variants: 2 tablet packets
Lot Numbers:
K9495 (Exp 02/2022)
AK9614 (Exp 05/2022)
Product: MAGNACAL (calcium carbonate 420 mg)by Afassco Inc.
Variants: 2 tablet packets
Lot Numbers:
AK9768 (Exp 08/2022)
Product: PEPTIME Energy (caffeine 250mg)by DMD Pharmaceuticals
Variants: Tablets, 100-count bottles, 6 count packets
Lot Numbers:
19E021
19E022
Product: PEPTIME Energy (caffeine 300mg)by DMD Pharmaceuticals
Variants: Tablets, 100-count bottles, 6 count packets
Lot Numbers:
19E030
19E031
Product: PEPTIME Energy (caffeine 350mg)by DMD Pharmaceuticals
Variants: Tablets, 100-count bottles, 6 count packets
Lot Numbers:
19E032
19E033
Product: CVS Health Natural Sleep Aid Chewable Tablets Cherry Flavor (melatonin 1.5mg)by CVS Health
Variants: 30-count bottles
Lot Numbers:
18L124 (Exp 02/2022)
19D029 (Exp 04/2022)
Product: MidNite Natural sleep aid Chewable Tablets Cherry Flavor (melatonin 1.5mg)by MidNite / BGP Pharma ULC
Variants: 30-count bottles
Lot Numbers:
19C038C (Exp 03/2022)
19G047C (Exp 07/2022)
18L124C (Exp 02/2022)
Product: Exaprin pain reliever (acetaminophen 110 mg, aspirin 162 mg, caffeine 32.4mg, salicylamide 152mg)by HARTHealth
Variants: Tablets, 2-tablet packets
Lot Numbers:
AK9796 (Exp 09/2022)
Product: Nutralox Mint Antacid (calcium carbonate 420mg)by HARTHealth
Variants: Chewable tablets, 2-count packets
Lot Numbers:
AK9566 (Exp 04/2022)
AK9612 (Exp 05/2022)
Product: FEM-PRIN MENSTRUAL RELIEF (acetaminophen 325 mg, pamabrom 25mg)by HARTHealth
Variants: Tablets, 2-count packets
Lot Numbers:
AK9695 (Exp 07/2022)
Product: CETAFEN COUGH & COLD COUGH & COLD RELIEF (Acetaminophen 325 mg, Dextromethorphan HBr 15mg, Guaifenesin 200mg, phenylephrine HCl 5mg)by HARTHealth
Variants: Coated tablets, 2-count packets
Lot Numbers:
AK9841 (Exp 10/2022)
Product: CETAFEN Extra Non-Aspirin Pain Relieve (Acetaminophen 500 mg)by HARTHealth
Variants: Caplets, 2-count packets
Lot Numbers:
AK9475 (Exp 02/2022)
Product: AYPANAL Non-aspirin Pain Reliever (acetaminophen 325 mg)by Honeywell Safety Products USA
Variants: Tablets, 2-count packets
Lot Numbers:
AK9640 (Exp 03/2022)
Product: SINUS DECONGESTANT Nasal Decongestant (phenylephrine HCl 5mg)by Honeywell Safety Products USA
Variants: Tablets, 2-count packets
Lot Numbers:
AK9859 (Exp 10/2022)
Product: MIRALAC (calcium carbonate 420mg)by Honeywell Safety Products USA
Variants: Tablets, Mint Flavor, 2-count packets
Lot Numbers:
AK9486 (Exp 02/2022)
Product: ELECTROLYTE Supplement Tablets (calcium 5.2 mg, Potassium 20.8 mg, Magnesium 6 mg)by Honeywell Safety Products USA
Variants: 2-count packets
Lot Numbers:
AK9797
AK9254
Product: SINU-PHEN PLUS sinus pain and congestion tabs (acetaminophen 500 mg, Phenylephrine HCl 5.0 mg)by Tellus Medical Products
Variants: 2 tablet packets
Lot Numbers:
AK9766 (Exp 08/2022)
NDC:
69103-2536-00
Product: Cystex Urinary Pan Relief (NSAID) (methenamine 162mg, sodium salicylate 162.5mg)by Clarion Brands, LLC
Variants: Tablets, 40-count blisters, 20-count blisters
Lot Numbers:
19A043 (Exp 01/2022)
19A093 (Exp 01/2022)
19B062 (Exp 03/2022)
19C079 (Exp 03/2022)
19C080 (Exp 03/2022)
19D041 (Exp 04/2022)
19E035 (Exp 05/2022)
19E087 (Exp 05/2022)
19G084 (Exp 08/2022)
19H098 (Exp 09/2022)
19H098A (Exp 09/2022)
NDC:
69693-512-40
Product: DBI 357 Super Magnum Quick Energy Stimulant (caffeine 200mg)by DBI Distribution
Variants: Tablets, 36-count bottles, 100-count bottles, 500-count bottles, 3-count packets
Lot Numbers:
C19065 (Exp 03/2022)
F19081 (Exp 06/2022)
19H083 (Exp 08/2022)
H19083 (Exp 08/2022)
1H9083 (Exp 08/2022)
19F081 (Exp 06/2022)
19083H (Exp 08/2022)
19C065 (Exp 03/2022)
19081F (Exp 06/2022)
Product: Ephedrine Plus (Ephedrine HCl 25mg, Guaifenesin 200mg)by DMD Pharmaceuticals
Variants: Tablets, 24-count bottles
Lot Numbers:
18M063 (Exp 01/2022)
19G076 (Exp 09/2022)
NDC:
65193-320-24
Product: Dologen (acetaminophen 325 mg and dexbrompheniramine maleate 1mg)by Kramer-Novis
Variants: Caplets, 90-count bottles, 2-count packets
Lot Numbers:
19G074 (Exp 07/2022)
19G075 (Exp 07/2022)
NDC:
52083-482-02
Product: MidNite Sleep Health (melatonin 1.5 mg)by MidNite / Mylan Consumer Healthcare, Inc.
Variants: Tablets, 30-count bottles
Lot Numbers:
18L124 (Exp 02/2022)
18L125 (Exp 02/2022)
18L126 (Exp 02/2022)
19C037 (Exp 03/2022)
19C038 (Exp 03/2022)
19C039 (Exp 03/2022)
19C040 (Exp 03/2022)
19D029 (Exp 04/2022)
19D030 (Exp 04/2022)
19D031 (Exp 06/2022)
19G047 (Exp 07/2022)
Product: Back Pain-Off (caffeine 50mg, magnesium salicylate 290mg)by Medique Products
Variants: Tablets, 2-count packets
Lot Numbers:
9708 (Exp 07/2022)
AK9810 (Exp 09/2022)
AK9946 (Exp 12/2022)
K9946 (Exp 12/2022)
NDC:
47682-073-00
Product: Cetafen Non-aspirin pain reliever (acetaminophen 325mg)by HARTHealth
Variants: Tablets, 2-count packets
Lot Numbers:
A-K-9668 (Exp 06/2022)
A-K-9475 (Exp 02/2022)
Product: Multi Symptom Cold Relief (acetaminophen 325 mg, Dextromethorphan HBr 15mg, Guaifenesin 200mg, Phenylephrine HCl 5mg)by Honeywell Safety Products USA
Variants: Tablets, 2-count packets
Lot Numbers:
AK9715 (Exp 07/2022)
K9715 (Exp 07/2022)
Product: Lite REMfresh Advanced Ion-Powered Melatonin (Melatonin 0.5mg)by REMfresh / Physician's Seal LLC
Variants: Tablets, 36-count blisters
Lot Numbers:
19E058A (Exp 05/2022)
19E058B (Exp 05/2022)
Product: Cold Relief Severe Pain/Cough (acetaminophen 325mg, Dextromethorphan HBr 15mg, Guaifenesin 200mg, phenylephrine HCl 5mg)by Select Corporation
Variants: 2-tablet packets
Lot Numbers:
AK9436 (Exp 01/2022)
Product: Multi-Symptom Cramp Relief (acetaminophen 325mg and Pamabrom 25mg)by First Aid Direct
Variants: 2 tablet packets
Lot Numbers:
AK9453 (Exp 01/2022)
AK9716 (Exp 07/2022)
Product: Backache & Muscle Relief (acetaminophen 250 mg, magnesium salicylate-tetrahydrate 290mg, caffeine 50 mg)by First Aid Direct
Variants: 2 tablets per packet
Lot Numbers:
K9770 (Exp 08/2022)
AK9770 (Exp 08/2022)
AK9958 (Exp 12/2022)
K9958 (Exp 12/2022)
AK9717 (Exp 07/2022)
AK9522 (Exp 03/2022)
AK9641 (Exp 03/2022)
AK9817 (Exp 09/2022)
NDC:
42961-111-832
Product: Cold Relief (acetaminophen 250 mg, guaifenesin 200mg, phenylephrine HCl 5 mg)by First Aid Direct
Variants: 2 tablets per packet
Lot Numbers:
K9456 (Exp 01/2022)
AK9454 (Exp 01/2022)
9456 (Exp 01/2022)
AK9456 (Exp 01/2022)
AK9524 (Exp 03/2022)
AK9528 (Exp 03/2022)
K9767 (Exp 08/2022)
AK9767 (Exp 08/2022)
AK9824 (Exp 09/2022)
AK9823 (Exp 09/2022)
AK9564 (Exp 04/2022)
NDC:
42961-112-03
Product: Headache & Congestion Sinus Relief (acetaminophen 250 mg, phenylephrine HCl 5 mg)by First Aid Direct
Variants: 2 tablets per packet
Lot Numbers:
9445 (Exp 01/2022)
AK9445 (Exp 01/2022)
K9445 (Exp 01/2022)
K9486 (Exp 02/2022)
AK9708 (Exp 07/2022)
AK9515 (Exp 03/2022)
K9810 (Exp 09/2022)
AK9658 (Exp 06/2022)
NDC:
42961-0206-02
Product: Pain Away Pain Reliever/Fever Reducer (NSAID) (acetaminophen 110 mg, aspirin 162 mg, salicylamide 152mg, caffeine 32.4 mg)by Respond Industries / American First Aid
Variants: 2 tablets per packet
Lot Numbers:
AK9493 (Exp 02/2022)
Product: Cold/Sinus Pain Reliever/Fever Reducer Nasal Decongestant (acetaminophen 325 mg, Phenylephrine HCl 5mg)by Respond Industries / American First Aid
Variants: 2 tablets per packet
Lot Numbers:
K9708 (Exp 07/2022)
Product: COLD TERMINATOR decongestant/cold relief (acetaminophen 325 mg, Guaifenesin 200mg, 5.0 Phenylephrine HCl)by Tellus Medical Products
Variants: 2 tablet packets
Lot Numbers:
AK9587 (Exp 02/2022)
NDC:
69103-2556
Product: PAIN TERMINATOR extra strength pain relief (aspirin 162 mg, acetaminophen 110 mg, Caffeine 32.4mg, Salicylamide 152 mg)by Tellus Medical Products
Variants: 2 tablet packets
Lot Numbers:
AK9451 (Exp 01/2022)
NDC:
69103-2507

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 89464
Status: Resolved
Manufacturer: Ultra Seal Corporation
Sold By: Physician's Seal LLC; Select Corporation; Cintas First Aid & Safety; Respond Industries; American First Aid; Aero Healthcare; Advanced First Aid; American Safety & First Aid; Afassco Inc.; Church & Dwight Co., Inc.; Clarion Brands, LLC; DBI Distribution; DMD Pharmaceuticals; Kramer-Novis; Mylan Consumer Healthcare, Inc.; MEDIQUE PRODUCTS; HARTHealth; Honeywell Safety Products USA; Tellus Medical Products; ZEE Medical Distributors, LLC; Just American Safety; CVS Pharmacy Inc.; BGP Pharma ULC
Manufactured In: United States
Units Affected: 55 products (3,508,200 packets; 313,000 packets; 226,390 packets; 1,236,000 packets; 225,350 packets; 297,050 packets; 174,852 bottles; a) 702,240 blisters, b) 30,180 blisters; a) 147,528 bottles, b) 2,451 bottles, c) 2,492 bottles, d) 573,696 packets; 301,842 bottles; a) 9,060 bottles, b) 44,700 packets; 2,189,232 bottles; 1,959,267 packets; 915,770 packets; 673,160 packets; 25,776 blisters; 227,010 packets; 1,351,660 packets; 5,107,565 packets; 7,858,690 packets; 5,741,384 packets; 1,186,000 packets; 301,650 packets; 226,400 packets; 1,188,280 packets; 122,400 packets; 2,685,700 packets; 1,694,200 packets; 2,336,600 packets; 111,300 packets; 769,200 packets; 447,050 packets; 1,309,800 packets; 887,000 packets; 1,180,000 packets; 533,100 packets; 307,000 packets; a)131,112 packets, b) 8,064 bottles; a) 113,040 packets, b) 7,132 bottles; a) 156,096 packets, b) 9,648 bottles; 241,560 bottles; 90,072 bottles; 1,1401,641 packets; 1,486,050 packets; 223,090 packets; 225,000 packets; 1,019,000 packets; 216,000 packets; 448,300 packets; 409,890 packets; 1,474,050 packets; a) 308,928 blisters b) 29,808 blisters; 40,344 blisters; 447,190 packets; 227,010 packets)
Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

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This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.