FDA Drug recall D-1242-2019
Carvedilol Tablets, USP, 3.125 mg, 500-count bottle, Rx Only, Manufactured by: Cadila Healthcare Ltd., India
- FDA Drug
- Class III
- terminated
- Published 2019-05-01
On 2019-05-01 the FDA classified a Class III recall of Carvedilol Tablets, USP, 3.125 mg, 500-count bottle, Rx Only, Manufactured by: Cadila Healthcare Ltd., India by Zydus Pharmaceuticals Usa, citing 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 ta….
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-1242-2019 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2019-04-22 |
| Published | 2019-05-01 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Zydus Pharmaceuticals Usa |
| Distribution | US |
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
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.
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 | Lot #: Z803518, Exp 08/2020 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1242-2019%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.