The Recall Desk
ModerateFDA (Drugs)·D-1109-2015·Announced 2015-06-03

Blenheim Pharmacal Recalls Captopril Tablets Due to cGMP Deviations

Blenheim Pharmacal is recalling 166 bottles of Captopril 50 mg tablets distributed in Indiana due to cGMP deviations and inadequate complaint investigations.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, which typically involves a situation where use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences. The source text cites cGMP deviations and inadequate complaint investigations rather than specific reported illnesses or injuries, fitting the Moderate severity criteria for low-risk contamination or voluntary precautionary recalls.

Plain-English summary

Blenheim Pharmacal, Inc. is recalling 166 bottles of Captopril Tablets, USP, 50 mg, 30 Tablets, Rx Only. The product is distributed by Wockhardt USA LLC and packaged by Blenheim Pharmacal, Inc. The specific lot number is BP20101301 with an expiration date of 02/28/2016. The NDC number is 10544-175-30.

The recall is being conducted in response to a recall notice from the manufacturer, Wockhardt Limited, following an FDA inspection. The inspection noted cGMP deviations, specifically inadequate investigation of market complaints. This resulted in the unsuccessful identification of root causes and a failure to expand the investigation to prevent repeat failures.

The affected product was distributed in Indiana. Consumers and healthcare providers should stop using the recalled product and contact their healthcare provider or pharmacist for guidance on alternative treatments or returns.

The recalled product

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
Manufacturer
Blenheim Pharmacal, Inc.
Category
Drug — Prescription Medication
Hazard
Affected units
166

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (2)

  • Lot BP20101301
  • Exp. Date 02/28/2016

Distribution

Distributed in 1 state:

Part of a larger recall action

This product is one of 2 recalled by Blenheim Pharmacal, Inc. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

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