Blenheim Pharmacal Recalls Captopril Tablets Due to cGMP Deviations
Blenheim Pharmacal recalls 166 bottles of Captopril Tablets, USP 50 mg due to current Good Manufacturing Practice deviations identified during an FDA inspection.
Recall notice
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
Contact the company
What happened, in plain English
Blenheim Pharmacal, Inc. is recalling a small quantity of Captopril Tablets, USP 50 mg because of manufacturing quality control failures. The recall was initiated after Wockhardt Limited issued a notice following an FDA inspection that found inadequate investigation of market complaints. This process failure meant root causes were not identified and measures to prevent repeat issues were not taken. Read more at govinfonow.com/recall/44666-blenheim-pharmacal-inc-recalls-captopril-tablets-usp-50-mg-30.
Source Summary by GovInfoNow · govinfonow.com/recall/44666-blenheim-pharmacal-inc-recalls-captopril-tablets-usp-50-mg-30 · Updated October 12, 2026 · FDA enforcement record: FDA #D-1109-2015
Cite this page
“Blenheim Pharmacal Recalls Captopril Tablets Due to cGMP Deviations.” GovInfoNow, updated October 12, 2026. https://govinfonow.com/recall/44666-blenheim-pharmacal-inc-recalls-captopril-tablets-usp-50-mg-30. Based on FDA recall #D-1109-2015 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1109-2015%22&limit=1).
Why it’s dangerous
The hazard stems from cGMP (current Good Manufacturing Practice) deviations, specifically inadequate investigation of market complaints and failure to identify root causes. Because the investigation was not expanded to prevent repeat failures, the quality and consistency of the medication cannot be guaranteed based on this record alone.
Who’s affected
Patients in Indiana who purchased the specific recalled lot of Captopril Tablets may be affected. The record does not specify what health risks or side effects might result from these manufacturing deviations.
How to tell if you have this one
Check for Captopril Tablets, USP, 50 mg, 30 Tablets, Rx Only. Look for NDC 10544-175-30, Lot BP20101301, and an expiration date of 02/28/2016. The product was distributed in Indiana.
- Brand
Blenheim Pharmacal- Category
Drug
All 2 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Classification
Class II- Status
Terminated- Distribution
Indiana
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| D-1109-2015 | 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; Lot BP20101301, Exp. Date 02/28/2016 | 166 bottles |
| D-1110-2015 | Clarithromycin Tablets, USP, 500 mg, 20 Tablets, Rx Only, Dist. By: Wockhardt USA LLC, Parsippany, NJ 07054, Repackaged By: Blenheim Pharmacal Inc. North Blenheim, NY 12131, NDC 10544-522-20, MFG: 64679-904-02; Lot BP18181301, Exp. Date 02/29/2016 | 50 bottles |
What to do — step by step
Contact Your Pharmacist
Verify if you have the recalled lot by checking your prescription records for Lot BP20101301 with an expiration date of 02/28/2016.
Follow Manufacturer Instructions
The recall record does not provide specific return or disposal instructions; contact Wockhardt USA LLC or your healthcare provider for guidance.
Where it went and when
Where it was distributed
Distributed in Indiana.
FDA distribution: “Indiana” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: Indiana.
Recall timeline
FDA terminated this recall 8 months after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
Questions people ask
Where was this product sold?
The distribution pattern for this recall is listed as Indiana.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #D-1109-2015 (May 22, 2015) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-1109-2015 to see it in context.
- Plain-language summary written by qwen3.6:35b-a3b on October 12, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.