The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-1257-2015·Announced 2015-07-29

Wockhardt Recalls Lisinopril Tablets Due to Inadequate Complaint Investigation

Wockhardt USA is recalling specific lots of Lisinopril 5 mg tablets because the firm did not adequately investigate customer complaints.

The agency’s classification

FDA (Drugs): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

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 temporary or medically reversible adverse health consequence. The specific cause is a CGMP deviation regarding complaint investigation, which is a procedural failure rather than a direct physical hazard like contamination or mislabeling, fitting the Moderate severity criteria for low-risk or procedural recalls.

Plain-English summary

Wockhardt USA Inc. is recalling Lisinopril Tablets USP, 5 mg, in 100, 500, and 1000 count bottles. The affected products are distributed nationwide, including Puerto Rico. The recall involves specific lot numbers and 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 failure to investigate complaints is a regulatory compliance issue rather than a confirmed product defect or safety hazard.

Consumers with these specific lots of Lisinopril 5 mg tablets should contact their pharmacist or healthcare provider for guidance. The product is prescription-only, so patients should not discontinue medication without consulting their prescriber.

The recalled product

Product
Lisinopril Tablets USP, 5 mg Tablets,Packaged in A) 100 Count Bottles (NDC: 64679-928-01), B) 500 Count Bottles (NDC: 64679-928-05), and C) 1000 Count Bottles (NDC: 64679-928-06), Rx Only. Manufactured by: Wockhardt Limited, Mumbai, India. Distributed by: Wockhardt USA LLC 20…
Manufacturer
Wockhardt Usa Inc.
Category
Drug — Antihypertensive
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 #: DM10991
  • Expiry: 4/30/2015
  • Lot #: DM11226
  • Lot #: DM11665
  • Expiry: 6/30/2015
  • Lot #: DM11810
  • Lot #: DM12702
  • Expiry: 9/30/2015
  • Lot #: DN10719
  • Expiry: 1/31/2016. B) Lot #: DM11651
  • Lot #: DM11652
  • Lot #: DM11664
  • Lot #: DM12701
  • Lot #: DN10139
  • Expiry: 12/31/2015. C) Lot #: DM11041
  • Lot #: DM11267
  • Lot #: DM11268
  • Lot #: DM11279
  • Expiry: 5/31/2015
  • Lot #: DM11286

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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