Carvedilol Tablets — Class II drug recall D-0753-2021
Terminated recall by Zydus Pharmaceuticals (USA) Inc, reported 2021-08-25, distributed nationwide. Presence of Foreign Tablets/Capsules; report of two Paroxetine tablets were found in the bottle
| Recall number | D-0753-2021 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Zydus Pharmaceuticals (USA) Inc, Pennington, NJ, United States |
| Recall initiated | 2021-08-13 |
| Classified | 2021-08-19 |
| Reported by FDA | 2021-08-25 |
| Terminated | 2023-04-03 |
| Distributed | Nationwide (US) |
| Quantity | 2,880 bottles |
| NDC | 68382-0092, 68382-0092-01, 68382-0092-05, 68382-0092-17, 68382-0093, 68382-0093-01, 68382-0093-05, 68382-0093-17, 68382-0094, 68382-0094-01, 68382-0094-05, 68382-0094-17, 68382-0095, 68382-0095-01, 68382-0095-05, 68382-0095-17 |
| Expiration dates | 2022-12-31 |
Product
Carvedilol Tablets, USP 25 mg, 500 Tablets bottles, Rx Only, Manufactured by: Cadila Healthcare Ltd., India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 0853, NDC 68382-095-05
Reason for recall
Presence of Foreign Tablets/Capsules; report of two Paroxetine tablets were found in the bottle
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-0753-2021. 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.