The Recall Desk
ModerateFDA (Drugs)·D-1245-2015·Announced 2015-07-29

Wockhardt Recalls Lamotrigine Extended-Release Tablets Due to CGMP Deviations

Wockhardt USA LLC is recalling 5,910 bottles of Lamotrigine Extended-Release Tablets, 25 mg, because the firm did not adequately investigate customer 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 investigation) without reported illnesses or injuries, fitting the criteria for moderate severity involving procedural or low-risk issues.

Plain-English summary

Wockhardt USA LLC is recalling 5,910 bottles of Lamotrigine Extended-Release Tablets, 25 mg, 30 Count Bottles. The product is prescription-only and was distributed nationwide in the United States, including Puerto Rico. The specific lot number is DN10114, with an expiration date of 11/30/2015.

The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations. Specifically, the firm did not adequately investigate customer complaints. The agency has classified this as a Class II recall.

Consumers with this product should contact their healthcare provider or pharmacist for guidance on how to dispose of or return the medication. Do not use the recalled product until further notice.

The recalled product

Product
Lamotrigine Extended-Release Tablets, 25 mg Tablets, 30 Count Bottles, Rx Only. Manufactured by: Wockhardt Limited, Mumbai, India. Distributed by: Wockhardt USA LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA. NDC: 64679-271-01.
Manufacturer
Wockhardt Usa Inc.
Category
Drug — Anticonvulsant
Hazard
Affected units
5,910

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 #: DN10114
  • Expiry: 11/30/2015.

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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