The Recall Desk
ModerateFDA (Drugs)·D-1347-2015·Announced 2015-08-26

Wockhardt Recalls Lisinopril Tablets Due to Inadequate Complaint Investigations

Wockhardt USA LLC is recalling 3,378 bottles of Lisinopril 20 mg tablets because an FDA inspection found inadequate investigations of past market 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 and involves a CGMP deviation regarding complaint investigations rather than a direct physical or chemical hazard to the product, fitting the criteria for a moderate severity voluntary precautionary recall.

Plain-English summary

Wockhardt USA LLC is voluntarily recalling 3,378 bottles of Lisinopril Tablets USP, 20 mg, 1000-count bottles. The product is distributed nationwide and is identified by Lot # DM13219 (Exp 10/15) and Lot # DM13428 (Exp 11/15). The NDC is 64679-941-06 and the UPC is 3 64679 94106 5.

The recall was initiated after an FDA inspection identified Current Good Manufacturing Practice (CGMP) deviations, specifically inadequate investigations of past market complaints. The agency has classified this recall as Class II.

Consumers and healthcare providers should check their inventory for the specific lot numbers and expiration dates listed above. If the product is found, it should be returned to the pharmacy or point of purchase for a refund or replacement.

The recalled product

Product
Lisinopril Tablets USP, 20 mg, 1000-count bottles, Rx Only, Manufactured by: Wockhardt Limited, Mumbai, India; Distributed by: Wockhardt USA LLC, 20 Waterview Blvd, Parsippany, NJ 07054 USA, UPC 3 64679 94106 5, NDC 64679-941-06.
Manufacturer
Wockhardt Usa Inc.
Category
Drug — Prescription Medication
Hazard
Affected units
3,378

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 (4)

  • Lot #: DM13219
  • Exp 10/15
  • DM13428
  • Exp 11/15

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 2 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 2 products in this recall →

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