Wockhardt Recalls Lisinopril Tablets Due to Inadequate Complaint Investigations
Wockhardt USA is recalling 1,704 bottles of Lisinopril 5 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 due to CGMP deviations (inadequate complaint investigations) without reported illnesses or injuries, fitting the 'Moderate' criteria for low-risk contamination or procedural issues.
Plain-English summary
Wockhardt USA LLC is recalling 1,704 bottles of Lisinopril Tablets USP, 5 mg, 1000-count bottles. The product is distributed nationwide and is identified by Lot # DM12700 with an expiration date of 09/15. The NDC is 64679-928-06 and the UPC is 3 64679 92806 6.
The recall was initiated following an FDA inspection that identified Current Good Manufacturing Practice (CGMP) deviations. Specifically, the inspection found that the manufacturer had conducted inadequate investigations of past market complaints. This is classified as an FDA Class II recall.
Consumers and healthcare providers with this specific lot of Lisinopril should stop using it and contact their healthcare provider or pharmacist for guidance on alternative treatment. The product is prescription-only.
The recalled product
- Product
- Lisinopril Tablets USP, 5 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 92806 6, NDC 64679-928-06.
- Manufacturer
- Wockhardt Usa Inc.
- Category
- Drug — Prescription Medication
- Affected units
- 1,704
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 (2)
- Lot #: DM12700
- Exp 09/15
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.
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