The Recall Desk
ModerateFDA (Drugs)·D-1261-2015·Announced 2015-07-29

Wockhardt Recalls Lisinopril Tablets Due to Complaint Investigation Failures

Wockhardt USA is recalling Lisinopril 40 mg tablets because the firm 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, which typically indicates a situation where use of the product may cause temporary or medically reversible health consequences. The specific hazard is a procedural CGMP deviation regarding complaint investigation, which is a quality control issue rather than a direct physical hazard like contamination or mislabeling.

Plain-English summary

Wockhardt USA LLC is recalling Lisinopril Tablets USP, 40 mg, in 100, 500, and 1000-count bottles. The product is distributed nationwide, including Puerto Rico. The recall involves specific lot numbers with expiration dates ranging from April 2015 to February 2016.

The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations. Specifically, the firm did not adequately investigate customer complaints. This procedural failure raises concerns about the quality control of the affected drug lots.

Consumers should stop using the recalled Lisinopril tablets and contact their healthcare provider for a replacement. The affected products are prescription-only and were distributed by Wockhardt USA LLC.

The recalled product

Product
Lisinopril Tablets USP, 40 mg Tablets, Packaged in A) 100 Count Bottles (NDC: 64679-942-01), B) 500 Count Bottles (NDC: 64679-942-05), and C) 1000 Count Bottles (NDC: 64679-942-02), Rx Only. Manufactured by: Wockhardt Limited, Mumbai, India. Distributed by: Wockhardt USA LLC 20 W
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 #: DM11040
  • Expiry: 4/30/2015
  • Lot #: DM11463
  • Expiry: 5/31/2015
  • Lot #: DM11497
  • Lot #: DM11498
  • Lot #: DM12126
  • Expiry: 7/31/2015
  • Lot #: DM12132
  • Lot #: DM12172
  • Lot #: DM12176
  • Lot #: DN10325
  • Expiry: 12/31/2015
  • Lot #: DN10892
  • Expiry: 2/29/2016. B) Lot #: DM11812
  • Expiry: 6/30/2015
  • Lot #: DM11816
  • Lot #: DM11821
  • Lot #: DM11822
  • Lot #: DM11827

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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