Ibuprofen 800mg — Class II drug recall D-0041-2025
Ongoing recall by Direct Rx, reported 2024-11-13, distributed nationwide. Failed Impurities/Degradation Specifications: Product failed impurity specifications at the 18-month stability
| Recall number | D-0041-2025 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Direct Rx, Dawsonville, GA, United States |
| Recall initiated | 2024-08-09 |
| Classified | 2024-11-07 |
| Reported by FDA | 2024-11-13 |
| Distributed | Nationwide (US) |
| Quantity | 1,410 bottles |
| Reason classes | specification failure |
| NDC | 61919-0621-15, 61919-0621-30, 61919-0621-40, 61919-0621-60, 61919-0621-71, 61919-0621-72, 61919-0621-90 |
| Expiration dates | 2026-11-30, 2026-12-31, 2027-01-31, 2027-02-28, 2027-03-31 |
Product
Ibuprofen 800mg, Generic for: Motrin, Each tablet contains: Ibuprofen, USP 800 mg, Packaged and Distributed by: DIRECT Rx, Dawsonville, GA 30534, Mfg By: Dr. Reddy's Laboratories LA, LLC, Shreveport, LA 71106, a) NDC 61919-0621-15 (15 count bottles), b) NDC 61919-0621-30 (30 count bottles, c) NDC 61919-0621-40 (40 count bottles), d) NDC 61919-0621-60 (60 count bottles), e) NDC 61919-0621-90 (90 count bottles), f) NDC: 61919-0621-100 and NDC: 61919-0621-71 (100 count bottles), g) NDC 61919-0621-72 (120 count bottles).
Reason for recall
Failed Impurities/Degradation Specifications: Product failed impurity specifications at the 18-month stability testing.
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-0041-2025. 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.