CLASS II Drug recall · Reported 3 Jun 2015 · FDA Enforcement Report
Captopril Tablets, USP, 50 mg recalled by Blenheim Pharmacal
Blenheim Pharmacal is recalling Captopril Tablets, USP, 50 mg, distributed in Indiana. The recall was initiated on 22 May 2015 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-1109-2015
- FDA event ID
- 71331
- Recalling firm
- Blenheim Pharmacal, North Blenheim, NY
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 22 May 2015
- FDA classified
- 28 May 2015
- Reported
- 3 Jun 2015
- Type
- Voluntary: Firm initiated
- Customers notified by
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Reason category
- Manufacturing (CGMP) Deviations
Timeline
| 22 May 2015 | Recall initiated by company | |
| 28 May 2015 | Classified by FDA | +6 days |
| 3 Jun 2015 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
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
Product as listed by the FDA
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
Where it was distributed
Indiana
Stores named: Walmart
Questions about this recall
Is Captopril Tablets, USP, 50 mg recalled?
Yes. Blenheim Pharmacal recalled Captopril Tablets, USP, 50 mg on 22 May 2015. The recall is Class II and its status is Terminated. Recall number D-1109-2015.
Why was it recalled?
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
Which lots are affected?
Lot BP20101301, Exp. Date 02/28/2016
Where was it sold?
Indiana
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Blenheim Pharmacal
All 2| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Clarithromycin Tablets, USP, 500 mg recalled by Blenheim Pharmacal | Blenheim Pharmacal | Manufacturing (CGMP) Deviations | IN |
Other Captopril recalls
All 5| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Captopril Tablets recalled by Wockhardt Usa | Wockhardt Usa | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Captopril Tablets recalled by Wockhardt Usa | Wockhardt Usa | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Captopril Tablets recalled by Wockhardt Usa | Wockhardt Usa | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Captopril Tablets, USP 5 mg recalled by Wockhardt Usa | Wockhardt Usa | Potency & Assay | Nationwide |