Medique Pain-Off (Medique Products) – Manufacturing Deviation (2021)
Class II: A situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Class II recall indicates potential for temporary health effects.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Medique Pain-Off (Acetaminophen 250 mg, Aspirin (NSAID*) 250 mg, Caffeine 65 mg) Tablets, packaged in 2-count Tablets per Unit Dose Packet, packaged as a) 200-count Tablets (100 x 2) Unit Dose packets per carton, UPC 3 47682 22847 7, Reorder #22847; b) 500-count Tablets (250 x 2) Unit Dose packets per carton, UPC 3 47682 22813 2, Reorder #22813; c) 100-count Tablets (50 x 2) Unit Dose packets per carton, UPC 3 47682 22833 0, Reorder #22833; d) 24-count Tablets (12 x 2) Unit Dose packets per car
Brand
Medique Products
Lot Codes / Batch Numbers
Lots: (packet lot, carton lot) a) 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, b) 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, c) 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, d) 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, 6152, 05783 Exp. 10/2021, 6749, 08866 Exp. 12/2022.
Products Sold
Lots: (packet lot, carton lot) a) 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; b) 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; c) 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; d) 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; 6152, 05783 Exp. 10/2021; 6749, 08866 Exp. 12/2022.
Medique Products is recalling Medique Pain-Off (Acetaminophen 250 mg, Aspirin (NSAID*) 250 mg, Caffeine 65 mg) Tablets, packaged i due to CGMP Deviations: manufacturer recalled after an FDA inspection noted that these products were not manufactured under Current Good Manufacturing Practi. This is a Class I recall, indicating a high risk of serious health consequences. Based on FDA drug enforcement report.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
CGMP Deviations: manufacturer recalled after an FDA inspection noted that these products were not manufactured under Current Good Manufacturing Practices.
Recommended Action
Per FDA guidance
Consumers should stop using the product and contact the recalling firm, their healthcare provider, or return it to the place of purchase.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 7, 2026