IBU Ibuprofen Tablets — Class II drug recall D-0646-2024
Ongoing recall by Dr. Reddy's Laboratories, Inc., reported 2024-09-04, distributed nationwide. Failed impurities/degradation specifications: results for unknown impurity, were 0.13% and 0.11% respectively,
| Recall number | D-0646-2024 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Dr. Reddy's Laboratories, Inc., Princeton, NJ, United States |
| Recall initiated | 2024-08-06 |
| Classified | 2024-08-26 |
| Reported by FDA | 2024-09-04 |
| Distributed | Nationwide (US) |
| Quantity | 14,940 bottles |
| Reason classes | specification failure |
| NDC | 55111-0682, 55111-0682-01, 55111-0682-05, 55111-0682-09, 55111-0683, 55111-0683-01, 55111-0683-05, 55111-0683-09, 55111-0683-30, 55111-0683-50, 55111-0684, 55111-0684-01, 55111-0684-05, 55111-0684-09, 55111-0684-30, 55111-0684-50, 55111-0684-60 |
| Lot numbers | C2207529, C2207530, C2210992, C2210993, C2210994, C2213304, C2213305 |
| Expiration dates | 2026-05-31, 2026-09-30, 2026-11-30 |
Product
IBU Ibuprofen Tablets, USP, 400 mg, Rx Only, Distributor: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540, Made in India, a) NDC 55111-682-01 - 100 Tablets per bottle, b) NDC 55111-682-05 - 500 Tablets per bottle.
Reason for recall
Failed impurities/degradation specifications: results for unknown impurity, were 0.13% and 0.11% respectively, exceeding the 0.10% specification limit.
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-0646-2024. 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.