The Recall Desk
ModerateFDA (Drugs)·D-1275-2015·Announced 2015-07-29

Wockhardt Recalls Captopril Tablets Due to CGMP Deviations

Wockhardt USA is recalling Captopril Tablets, USP, 25 mg due to inadequate investigation of customer complaints.

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 specific hazard is a CGMP deviation regarding complaint investigation, which is a quality control issue rather than a direct physical hazard like contamination or mislabeling of a common allergen.

Plain-English summary

Wockhardt USA LLC is recalling Captopril Tablets, USP, 25 mg, packaged in 100-count and 1,000-count bottles. The product is prescription-only and was distributed nationwide, including Puerto Rico.

The recall was initiated because the firm did not adequately investigate customer complaints, which constitutes a Current Good Manufacturing Practice (CGMP) deviation. The affected lots include specific lot numbers and expiration dates ranging from April 2015 to July 2016.

Consumers with these specific lot numbers should stop using the medication and contact their healthcare provider or pharmacist for guidance on obtaining a replacement.

The recalled product

Product
Captopril Tablets, USP, 25 mg Tablets, Packaged in A) 100 Count Bottles (NDC: 64679-0903-01) and B) 1000 Count Bottles (NDC: 64679-0903-02), Rx only. Manufactured by: Wockhardt Limited, Mumbai, India. Distributed by: Wockhardt USA LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA.
Manufacturer
Wockhardt Usa Inc.
Category
Drug — Prescription Medication
Hazard

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 (20)

  • A) Lot #: LM10843
  • Expiry: 5/31/2015
  • Lot #: LM11331
  • Expiry: 7/31/2015
  • Lot #: LM11332
  • Lot #: LM11376
  • Lot #: LM11583
  • Expiry: 8/31/2015
  • Lot #: LM11987
  • Expiry: 11/30/2015
  • Lot #: LN10065
  • Expiry: 12/31/2015
  • Lot #: LN10066
  • Lot #: LN10334
  • Expiry: 1/31/2016
  • Lot #: LN10335
  • Lot #: LN10443
  • Lot #: LN10879
  • Expiry: 4/30/2016
  • Lot #: LN10971

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

Part of a larger recall action

This product is one of 35 recalled by Wockhardt Usa 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 35 products in this recall →

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