Carvedilol Tablets — Class II drug recall D-1273-2019
Terminated recall by Zydus Pharmaceuticals USA Inc, reported 2019-05-15, distributed nationwide. Labeling; Label Mix-up; report received of one bottle labeled as Acyclovir Tablets USP 400 mg actually contain
| Recall number | D-1273-2019 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Zydus Pharmaceuticals USA Inc, Pennington, NJ, United States |
| Recall initiated | 2019-04-25 |
| Classified | 2019-05-07 |
| Reported by FDA | 2019-05-15 |
| Terminated | 2021-06-29 |
| Distributed | Nationwide (US) |
| Quantity | 3,900 |
| Reason classes | labeling |
| 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 | 2020-11-30 |
Product
Carvedilol Tablets, USP, 6.25 mg, 500 count bottles, Rx Only Manufactured by: Cadila Healthcare Ltd., India Distributed by: Zydus Pharmaceuticals (USA) Inc. Pennington, NJ USA 08534 NDC 68382-093-05
Reason for recall
Labeling; Label Mix-up; report received of one bottle labeled as Acyclovir Tablets USP 400 mg actually contained Carvedilol Tablets 6.25 mg
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-1273-2019. 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.