Reported Jan 26, 2022 · Terminated

Medique Pain-Off (Acetaminophen 250 mg, Aspirin (NSAID*) 250 mg, Caffeine 65 mg) Tablets, packaged in 2-count Tablets…

Medique Products

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Medique Products · 17080 Alico Commerce Ct Ste 1 · Fort Myers, FL · 33967-8509

Is this the product you have?

8 of 8 products

Products covered by this recall
#Product as published
1200-count Tablets (100 x
2Unit Dose packets per carton, UPC 3 47682 22847 7, Reorder #22847
3500-count Tablets (250 x
4Unit Dose packets per carton, UPC 3 47682 22813 2, Reorder #22813
5100-count Tablets (50 x
6Unit Dose packets per carton, UPC 3 47682 22833 0, Reorder #22833
724-count Tablets (12 x
8Unit Dose packets per carton, UPC 3 47682 22864 4, Reorder #22864; Manufactured for Medique Products, Fort Myers, FL 33967.
Lot codes and dates

4 of 4 products

Products covered by this recall
#Product as published
17062, 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
26856, 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
37070, 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
47062, 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; 6152, 05783 Exp. 10/2021; 6749, 08866 Exp. 12/2022.
Amount recalled
16,630,118 tablets

This recall covers 3 products

The agency filed one notice per product. You are reading one of them; the other 2 are below.

Where it was sold

  • Nationwide

Why it was recalled

CGMP Deviations: manufacturer recalled after an FDA inspection noted that these products were not manufactured under Current Good Manufacturing Practices.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA drug enforcement) notice

Notice updated Jun 21, 2023 · Data as of Sep 19, 8:08 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.