Medications & Supplements/Over-the-Counter

Medique and Physicians CARE Pain Relievers Recalled for Manufacturing Issues

Agency Publication Date: January 20, 2022

Summary

Medique Products has recalled 26,530,356 tablets of Physicians CARE, Medique Pain-Off, and Extra Strength Headache pain relief medications. These products, which contain acetaminophen, aspirin, and caffeine, were manufactured under conditions that did not meet Current Good Manufacturing Practices. Using medications that are not produced according to these safety standards can lead to risks regarding the drug's quality and consistency.

Risk

The medications were produced with manufacturing deviations that violate federal safety standards. While no injuries or adverse reactions have been reported to date, failure to follow good manufacturing practices can compromise the safety and effectiveness of the medication.

What You Should Do

This recall affects Physicians CARE Extra Strength PAIN RELIEVER, Medique Pain-Off, and Extra Strength Headache relief tablets sold in various carton sizes and individual packets.
Check the box or the individual unit dose packets for the brand name and the lot numbers provided. See the Affected Products section below for the full list of affected codes.
If you have health concerns after using these pain relievers, contact your healthcare provider or pharmacist.
Return any unused product to the place of purchase for a refund, throw it away, or contact Medique Products for further instructions.
For additional questions, call the FDA Consumer Complaint hotline at 1-888-723-3332.

Your Remedy Options

You have 2 options:

Option 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

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: Physicians CARE Extra Strength PAIN RELIEVER

Variants: Acetaminophen 250 mg, Aspirin (NSAID) 250 mg, Caffeine 65 mg, 100-count Carton, 50 Packets of 2 tablets each

UPC Codes:

073577903166

Lot Numbers:

6151, 4360 (Exp. 10/2021)

6240, 4446 (Exp. 12/2021)

6331, 4484 (Exp. 02/2022)

6413, 4551 (Exp. 04/2022)

6699, 4679 (Exp. 10/2022)

6751, 4714 (Exp. 12/2022)

6855, 4750 (Exp. 01/2023)

6868, 4761 (Exp. 02/2023)

6899, 4776 (Exp. 02/2023)

7061, 4821 (Exp. 05/2023)

Manufactured for Acme United Corporation.

Product: Medique Pain-Off Tablets

Variants: Acetaminophen 250 mg, Aspirin (NSAID) 250 mg, Caffeine 65 mg, 2-count Unit Dose Packets, 24-count, 100-count, 200-count, and 500-count Cartons

Model:

Reorder #22847

Reorder #22813

Reorder #22833

Reorder #22864

UPC Codes:

347682228477

347682228132

347682228330

347682228644

Lot Numbers (52):

7062, 10611 (Exp. 05/2023)

7062, 10110 (Exp. 05/2023)

7062, 10067 (Exp. 05/2023)

6414, 07378 (Exp. 04/2022)

6700, 08047 (Exp. 10/2022)

6152, 05553 (Exp. 10/2022)

6239, 07120 (Exp. 12/2021)

6239, 06504 (Exp. 12/2021)

6152, 05737 (Exp. 10/2021)

6700, 08653 (Exp. 10/2022)

6330, 07217 (Exp. 02/2022)

6414, 07360 (Exp. 04/2022)

6749, 08717 (Exp. 12/2022)

6794, 09012 (Exp. 12/2022)

6856, 09108 (Exp. 01/2023)

6867, 09460 (Exp. 02/2023)

6900, 10105 (Exp. 02/2023)

6749, 09139 (Exp. 12/2022)

6152, 05944 (Exp. 10/2021)

6152, 05483 (Exp. 10/2021)

6414, 07488 (Exp. 04/2022)

6493, 07662 (Exp. 06/2022)

6414, 07286 (Exp. 04/2022)

6493, 07709 (Exp. 06/2022)

6414, 07524 (Exp. 04/2022)

6330, 06728 (Exp. 02/2022)

6330, 06366 (Exp. 02/2022)

6239, 06503 (Exp. 12/2021)

6330, 06460 (Exp. 02/2022)

7070, 10605 (Exp. 06/2023)

7063, 11089 (Exp. 06/2023)

7070, 11020 (Exp. 06/2023)

6867, 09545 (Exp. 02/2023)

7062, 10066 (Exp. 05/2023)

6749, 08650 (Exp. 12/2022)

6493, 07784 (Exp. 06/2022)

6493, 07920 (Exp. 06/2022)

6330, 06949 (Exp. 02/2022)

6239, 06945 (Exp. 12/2021)

6239, 05973 (Exp. 12/2021)

6152, 05687 (Exp. 10/2021)

6493, 07950 (Exp. 06/2022)

6493, 07825 (Exp. 06/2022)

7062, 10265 (Exp. 05/2023)

7070, 10980 (Exp. 06/2023)

6867, 09607 (Exp. 02/2023)

6152, 06039 (Exp. 10/2021)

6330, 07121 (Exp. 02/2022)

6700, 08040 (Exp. 10/2022)

6493, 07985 (Exp. 06/2022)

Manufactured for Medique Products.

Product: Extra Strength Headache Tablets

Variants: Acetaminophen 250 mg, Aspirin 250 mg, Caffeine 65 mg, 2-count tablets per packet

Lot Numbers:

6492 (Exp. 06/2022)

6701 (Exp. 10/2022)

6750 (Exp. 12/2022)

6853 (Exp. 01/2023)

6854 (Exp. 01/2023)

6869 (Exp. 02/2023)

6898 (Exp. 02/2023)

6901 (Exp. 02/2023)

7059 (Exp. 05/2023)

7060 (Exp. 05/2023)

7064 (Exp. 06/2023)

7065 (Exp. 06/2023)

Manufactured for Lil' Drug Store Products, Inc.

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 89356

Status: Resolved

Manufacturer: Medique Products

Sold By: Acme United Corporation; Lil' Drug Store Products, Inc.; Medique Products

Manufactured In: United States

Units Affected: 3 products (3,260,400 tablets; 16,630,118 tablets; 6,639,838 tablets)

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.

Find an Attorney

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 · 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.

Summary

What You Should Do

This recall affects Physicians CARE Extra Strength PAIN RELIEVER, Medique Pain-Off, and Extra Strength Headache relief tablets sold in various carton sizes and individual packets.

Check the box or the individual unit dose packets for the brand name and the lot numbers provided. See the Affected Products section below for the full list of affected codes.

If you have health concerns after using these pain relievers, contact your healthcare provider or pharmacist.

Return any unused product to the place of purchase for a refund, throw it away, or contact Medique Products for further instructions.

For additional questions, call the FDA Consumer Complaint hotline at 1-888-723-3332.

Your Remedy Options

You have 2 options:

Option 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

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: Physicians CARE Extra Strength PAIN RELIEVER

Variants: Acetaminophen 250 mg, Aspirin (NSAID) 250 mg, Caffeine 65 mg, 100-count Carton, 50 Packets of 2 tablets each

UPC Codes:

073577903166

Lot Numbers:

6151, 4360 (Exp. 10/2021)

6240, 4446 (Exp. 12/2021)

6331, 4484 (Exp. 02/2022)

6413, 4551 (Exp. 04/2022)

6699, 4679 (Exp. 10/2022)

6751, 4714 (Exp. 12/2022)

6855, 4750 (Exp. 01/2023)

6868, 4761 (Exp. 02/2023)

6899, 4776 (Exp. 02/2023)

7061, 4821 (Exp. 05/2023)

Manufactured for Acme United Corporation.

Product: Medique Pain-Off Tablets

Variants: Acetaminophen 250 mg, Aspirin (NSAID) 250 mg, Caffeine 65 mg, 2-count Unit Dose Packets, 24-count, 100-count, 200-count, and 500-count Cartons

Model:

Reorder #22847

Reorder #22813

Reorder #22833

Reorder #22864

UPC Codes:

347682228477

347682228132

347682228330

347682228644

Lot Numbers (52):

7062, 10611 (Exp. 05/2023)

7062, 10110 (Exp. 05/2023)

7062, 10067 (Exp. 05/2023)

6414, 07378 (Exp. 04/2022)

6700, 08047 (Exp. 10/2022)

6152, 05553 (Exp. 10/2022)

6239, 07120 (Exp. 12/2021)

6239, 06504 (Exp. 12/2021)

6152, 05737 (Exp. 10/2021)

6700, 08653 (Exp. 10/2022)

6330, 07217 (Exp. 02/2022)

6414, 07360 (Exp. 04/2022)

6749, 08717 (Exp. 12/2022)

6794, 09012 (Exp. 12/2022)

6856, 09108 (Exp. 01/2023)

6867, 09460 (Exp. 02/2023)

6900, 10105 (Exp. 02/2023)

6749, 09139 (Exp. 12/2022)

6152, 05944 (Exp. 10/2021)

6152, 05483 (Exp. 10/2021)

6414, 07488 (Exp. 04/2022)

6493, 07662 (Exp. 06/2022)

6414, 07286 (Exp. 04/2022)

6493, 07709 (Exp. 06/2022)

6414, 07524 (Exp. 04/2022)

6330, 06728 (Exp. 02/2022)

6330, 06366 (Exp. 02/2022)

6239, 06503 (Exp. 12/2021)

6330, 06460 (Exp. 02/2022)

7070, 10605 (Exp. 06/2023)

7063, 11089 (Exp. 06/2023)

7070, 11020 (Exp. 06/2023)

6867, 09545 (Exp. 02/2023)

7062, 10066 (Exp. 05/2023)

6749, 08650 (Exp. 12/2022)

6493, 07784 (Exp. 06/2022)

6493, 07920 (Exp. 06/2022)

6330, 06949 (Exp. 02/2022)

6239, 06945 (Exp. 12/2021)

6239, 05973 (Exp. 12/2021)

6152, 05687 (Exp. 10/2021)

6493, 07950 (Exp. 06/2022)

6493, 07825 (Exp. 06/2022)

7062, 10265 (Exp. 05/2023)

7070, 10980 (Exp. 06/2023)

6867, 09607 (Exp. 02/2023)

6152, 06039 (Exp. 10/2021)

6330, 07121 (Exp. 02/2022)

6700, 08040 (Exp. 10/2022)

6493, 07985 (Exp. 06/2022)

Manufactured for Medique Products.

Product: Extra Strength Headache Tablets

Variants: Acetaminophen 250 mg, Aspirin 250 mg, Caffeine 65 mg, 2-count tablets per packet

Lot Numbers:

6492 (Exp. 06/2022)

6701 (Exp. 10/2022)

6750 (Exp. 12/2022)

6853 (Exp. 01/2023)

6854 (Exp. 01/2023)

6869 (Exp. 02/2023)

6898 (Exp. 02/2023)

6901 (Exp. 02/2023)

7059 (Exp. 05/2023)

7060 (Exp. 05/2023)

7064 (Exp. 06/2023)

7065 (Exp. 06/2023)

Manufactured for Lil' Drug Store Products, Inc.

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 89356

Status: Resolved

Manufacturer: Medique Products

Sold By: Acme United Corporation; Lil' Drug Store Products, Inc.; Medique Products

Manufactured In: United States

Units Affected: 3 products (3,260,400 tablets; 16,630,118 tablets; 6,639,838 tablets)

Distributed To: Nationwide