The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-1258-2015·Announced 2015-07-29

Wockhardt Recalls Lisinopril Tablets Due to Inadequate Complaint Investigation

Wockhardt USA is recalling Lisinopril 10 mg tablets because the firm did not adequately investigate customer complaints. The recall covers multiple lot numbers distributed nationwide.

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 due to CGMP deviations (inadequate complaint investigation) without reported injuries or illnesses, fitting the 'Moderate' criteria for voluntary precautionary or minor process errors.

Plain-English summary

Wockhardt USA Inc. is recalling Lisinopril Tablets USP, 10 mg, in 100, 500, and 1000-count bottles. The product is manufactured by Wockhardt Limited in Mumbai, India, and distributed by Wockhardt USA LLC in Parsippany, New Jersey. The recall affects 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 is a Class II recall, indicating a situation where use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

The affected products were distributed nationwide in the United States, including Puerto Rico. Consumers and healthcare providers should check their inventory for the specific lot numbers listed in the recall notice. If the product is found, it should be returned to the distributor or disposed of according to local regulations. Patients should consult their healthcare provider for alternative medication options if necessary.

The recalled product

Product
Lisinopril Tablets USP, 10 mg Tablets, Packaged in A) 100 Count Bottles (NDC: 64679-929-01), B) 500 Count Bottles (NDC: 64679-929-05), and C) 1000 Count Bottles (NDC: 64679-929-06), Rx Only. Manufactured by: Wockhardt Limited, Mumbai, India. Distributed by: Wockhardt USA LLC 20…
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 #: DM11197
  • Expiry: 4/30/2015
  • Lot #: DM11202
  • Lot #: DM11641
  • Expiry: 6/30/2015
  • Lot #: DM12237
  • Expiry: 8/31/2015
  • Lot #: DM12238
  • Lot #: DM12285
  • Lot #: DN10176
  • Expiry: 12/31/2015
  • Lot #: DN10636
  • Expiry: 1/31/2016
  • Lot #: DN10869
  • Expiry: 2/29/2016. B) Lot #: DM11646
  • Lot #: DM12364
  • Expiry: 8/31/2015. C) Lot #: DM11136
  • Lot #: DM11137
  • Lot #: DM11142
  • Lot #: DM11150

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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