Extra Strength Headache — Class II drug recall D-0391-2022
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-0391-2022 |
|---|---|
| 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 | 6,639,838 tablets |
| Reason classes | cgmp |
| Lot numbers | 6492, 6701, 6750, 6853, 6854, 6869, 6898, 6901, 7059, 7060, 7064, 7065 |
| Expiration dates | 2022-06, 2022-10, 2022-12, 2023-01, 2023-02, 2023-05, 2023-06 |
Product
Extra Strength Headache (acetaminophen 250 mg, aspirin 250 mg, caffeine 65 mg) tablets, packaged in 2-count tablets per packet, Manufactured for: Lil' Drug Store Products, Inc., Cedar Rapids, IA 52404
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-0391-2022. 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.