Clopidogrel Tablets — Class II drug recall D-0294-2019
Terminated recall by Dr. Reddy's Laboratories, Inc., reported 2018-12-19, distributed nationwide. Failed dissolution specification -Two additional lots being recalled due to Out-of-Specification results obser
| Recall number | D-0294-2019 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Dr. Reddy's Laboratories, Inc., Princeton, NJ, United States |
| Recall initiated | 2018-12-10 |
| Classified | 2018-12-11 |
| Reported by FDA | 2018-12-19 |
| Terminated | 2020-06-25 |
| Distributed | Nationwide (US) |
| Quantity | 4,404 |
| Reason classes | specification failure |
| NDC | 55111-0671, 55111-0671-01, 55111-0671-05, 55111-0671-06, 55111-0671-30, 55111-0671-31, 55111-0671-48, 55111-0671-78, 55111-0671-79, 55111-0671-81, 55111-0671-90 |
| Lot numbers | T700423, T800310 |
| Expiration dates | 2019-08, 2020-03 |
Product
Clopidogrel Tablets, USP, 300 mg, 30 (5 x 6 unit-dose) count blister pack, Rx only, Manufactured by Dr. Reddy's Laboratories Limited, Srikakulam - 532 409, India, NDC 55111-671-31
Reason for recall
Failed dissolution specification -Two additional lots being recalled due to Out-of-Specification results observed for dissolution at 18th 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-0294-2019. 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.