FDA Drug recall D-1109-2015
Captopril Tablets, USP, 50 mg, 30 Tablets, Rx Only, Dist
- FDA Drug
- Class II
- terminated
- Published 2015-06-03
On 2015-06-03 the FDA classified a Class II recall of Captopril Tablets, USP, 50 mg, 30 Tablets, Rx Only, Dist by Blenheim Pharmacal, citing cGMP Deviations; products being recalled in response to a recall notice from the manufacturer, Wockhardt Limited, following a FDA inspection which noted inadequate investigation o….
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-1109-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-05-22 |
| Published | 2015-06-03 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Blenheim Pharmacal |
| Distribution | IN |
Product
Captopril Tablets, USP, 50 mg, 30 Tablets, Rx Only, Dist. By: Wockhardt USA LLC, Parsippany, NJ 07054, Packaged By: Blenheim Pharmacal Inc. North Blenheim, NY 12131, NDC 10544-175-30, MFG: 64679-904-02
Reason
cGMP Deviations; products being recalled in response to a recall notice from the manufacturer, Wockhardt Limited, following a FDA inspection which noted inadequate investigation of market complaints, resulting in unsuccessful identification of root causes, and the investigation not being expanded to prevent repeat failure
Identifiers
| code_info | Lot BP20101301, Exp. Date 02/28/2016 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1109-2015%22
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