The Recall Desk
ModerateFDA (Drugs)·D-1276-2015·Announced 2015-07-29

Wockhardt Recalls Captopril Tablets Due to Inadequate Complaint Investigation

Wockhardt USA is recalling Captopril 50 mg tablets because the manufacturer did not adequately investigate 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, but the source text explicitly states no illnesses or injuries were reported. The hazard is a procedural CGMP deviation (inadequate complaint investigation) rather than a direct physical or chemical defect with known harm, fitting the 'Moderate' criteria for low-risk or procedural issues without reported adverse events.

Plain-English summary

Wockhardt USA is recalling Captopril Tablets, USP, 50 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 due to Current Good Manufacturing Practice (CGMP) deviations. Specifically, the firm did not adequately investigate customer complaints. The source text does not report any illnesses, injuries, or deaths associated with this recall.

Consumers should stop using the affected medication and contact their healthcare provider or pharmacist for guidance. The affected lots include specific expiration dates ranging from April 2015 to July 2016 for both 100-count and 1,000-count bottles.

The recalled product

Product
Captopril Tablets, USP, 50 mg Tablets, Packaged in A) 100 Count Bottles (NDC: 64679-0904-01) and B) 1000 Count Bottles (NDC: 64679-0904-02), 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 #: LM11093
  • Expiry: 6/30/2015
  • Lot #: LM11335
  • Expiry: 7/31/2015
  • Lot #: LM11336
  • Lot #: LM11461
  • Expiry: 8/31/2015
  • Lot #: LM11462
  • Lot #: LM11579
  • Lot #: LM11778
  • Expiry: 9/30/2015
  • Lot #: LM11995
  • Expiry: 11/30/2015
  • Lot #: LN10029
  • Lot #: LN10071
  • Expiry: 12/31/2015
  • Lot #: LN10349
  • Expiry: 1/31/2016
  • Lot #: LN10350
  • Lot #: LN10505

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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