Medique Pain-Off — Class II drug recall D-0390-2022
Terminated recall by Medique Products, reported 2022-01-26, distributed nationwide. CGMP Deviations: manufacturer recalled after an FDA inspection noted that these products were not manufactured
| Recall number | D-0390-2022 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Medique Products, Fort Myers, FL, United States |
| Recall initiated | 2021-12-06 |
| Classified | 2022-01-20 |
| Reported by FDA | 2022-01-26 |
| Terminated | 2023-06-21 |
| Distributed | Nationwide (US) |
| Quantity | 16,630,118 tablets |
| Reason classes | cgmp |
| UPC / GTIN / UDI-DI | 00347682228132, 00347682228330, 00347682228477, 00347682228644 |
| Lot numbers | 05483, 05553, 05687, 05737, 05783, 05944, 05973, 06039, 06366, 06460, 06503, 06504, 06728, 06945, 06949, 07120, 07121, 07217, 07286, 07360, 07378, 07488, 07524, 07662, 07709, 07784, 07825, 07920, 07950, 07985, 08040, 08047, 08650, 08653, 08717, 08866, 09012, 09108, 09139, 09460 and 26 more |
| Expiration dates | 2021-10, 2021-12, 2022-02, 2022-04, 2022-06, 2022-10, 2022-12, 2023-01, 2023-02, 2023-05, 2023-06 |
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 carton, UPC 3 47682 22864 4, Reorder #22864; Manufactured for Medique Products, Fort Myers, FL 33967.
Reason for recall
CGMP Deviations: manufacturer recalled after an FDA inspection noted that these products were not manufactured under Current Good Manufacturing Practices.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0390-2022. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.