The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-1260-2015·Announced 2015-07-29

Wockhardt Recalls Lisinopril Tablets Due to Complaint Investigation Failures

Wockhardt USA is recalling specific lots of Lisinopril 30 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 the rubric associates with moderate severity when no specific injuries or illnesses are reported, and the hazard is a procedural CGMP deviation rather than a direct physical defect.

Plain-English summary

Wockhardt USA LLC is recalling specific lots of Lisinopril Tablets USP, 30 mg, packaged in 100-count and 500-count bottles. The affected products are prescription-only and were distributed nationwide in the United States, including Puerto Rico.

The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations. Specifically, the firm failed to adequately investigate customer complaints regarding these products.

Consumers with these specific lots should stop using the medication and contact their healthcare provider or pharmacist for guidance. The affected lot numbers and expiration dates are listed in the structured product information.

The recalled product

Product
Lisinopril Tablets USP, 30 mg Tablets, Packaged in A) 100 Count Bottles (NDC: 64679-953-01) and B) 500 Count Bottles (NDC: 64679-953-05), 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 #: DM11003
  • Expiry: 4/30/2015
  • Lot #: DM11094
  • Lot #: DM11689
  • Expiry: 6/30/2015
  • Lot #: DM11873
  • Lot #: DM11874
  • Lot #: DM12402
  • Expiry: 8/31/2015
  • Lot #: DM12412
  • Lot #: DM13440
  • Expiry: 11/30/2015
  • Lot #: DN10689
  • Expiry: 1/31/2016
  • Lot #: DN10693
  • Expiry: 1/31/2016. B) Lot #: DM11095
  • Lot #: DM11688
  • Lot #: DM11860
  • Lot #: DM12413
  • Lot #: DN10692

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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