Clopidogrel Tablets — Class II drug recall D-0283-2019
Terminated recall by Dr. Reddy's Laboratories, Inc., reported 2018-11-28, distributed nationwide. Failed Dissolution Specification: Out-of-Specification results were observed for dissolution at 18th month sta
| Recall number | D-0283-2019 |
|---|---|
| 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 | 2018-11-07 |
| Classified | 2018-11-27 |
| Reported by FDA | 2018-11-28 |
| Terminated | 2020-05-19 |
| Distributed | Nationwide (US) |
| 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 | 11/18, T600530 |
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: Out-of-Specification results were 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-0283-2019. 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.