Carvedilol Tablets — Class III drug recall D-1242-2019
Terminated recall by Zydus Pharmaceuticals USA Inc, reported 2019-05-01, distributed nationwide. Presence of Foreign Tablets/Capsules: Customer complaint for a small, solid, light yellow substance, identifie
| Recall number | D-1242-2019 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Zydus Pharmaceuticals USA Inc, Pennington, NJ, United States |
| Recall initiated | 2019-04-22 |
| Classified | 2019-04-25 |
| Reported by FDA | 2019-05-01 |
| Terminated | 2021-01-14 |
| Distributed | Nationwide (US) |
| Quantity | 7,668 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 |
| Lot numbers | Z803518 |
| Expiration dates | 2020-08 |
Product
Carvedilol Tablets, USP, 3.125 mg, 500-count bottle, Rx Only, Manufactured by: Cadila Healthcare Ltd., India; Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534; NDC 68382-092-05
Reason for recall
Presence of Foreign Tablets/Capsules: Customer complaint for a small, solid, light yellow substance, identified as a fragmented tablet of another drug product, found mixed with tablets in a bottle of Carvedilol tablets 3.125mg.
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-1242-2019. 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.