FDA Drug recall D-0753-2021
Carvedilol Tablets, USP 25 mg, 500 Tablets bottles, Rx Only, Manufactured by: Cadila Healthcare Ltd., India, Distributed by: Zydus Pharmace…
- FDA Drug
- Class II
- terminated
- Published 2021-08-25
On 2021-08-25 the FDA classified a Class II recall of Carvedilol Tablets, USP 25 mg, 500 Tablets bottles, Rx Only, Manufactured by: Cadila Healthcare Ltd., India, Distributed by: Zydus Pharmace… by Zydus Pharmaceuticals Usa, citing presence of Foreign Tablets/Capsules; report of two Paroxetine tablets were found in the bottle.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0753-2021 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2021-08-13 |
| Published | 2021-08-25 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Zydus Pharmaceuticals Usa |
| Distribution | US |
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
Presence of Foreign Tablets/Capsules; report of two Paroxetine tablets were found in the bottle
Identifiers
| ndc | 68382-092-17 |
|---|---|
| ndc | 68382-092-01 |
| ndc | 68382-092-05 |
| ndc | 68382-093-17 |
| ndc | 68382-093-05 |
| ndc | 68382-093-01 |
| ndc | 68382-094-17 |
| ndc | 68382-094-01 |
| ndc | 68382-094-05 |
| ndc | 68382-095-17 |
| ndc | 68382-095-01 |
| ndc | 68382-095-05 |
| code_info | Z006279, exp 12/31/2022 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
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All Zydus Pharmaceuticals Usa recalls
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0753-2021%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.