Class I โ€” Serious Health Hazard

Serious health hazard โ€” there is a reasonable probability that use of or exposure to this product will cause serious adverse health consequences or death.

Lamotrigine Orally Disintegrating Tablets (ODT) Recalled by Impax Laboratories, Inc. Due to Labeling; Label Mixup; box labeled to contain 200...

Date: August 19, 2016
Company: Impax Laboratories, Inc.
Status: Terminated
Source: FDA (Drug)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Impax Laboratories, Inc. directly.

Affected Products

Lamotrigine Orally Disintegrating Tablets (ODT), 200 mg, 30 Tablets 3 blisters containing 10 tablets each, Rx only, Manufactured by: Watson Pharma Private Ltd., Verna, Salcette Goa INDIA, Distributed by: Impax Generics, Hayward, CA

Quantity: 3,074 boxes (30 count boxes)

Why Was This Recalled?

Labeling; Label Mixup; box labeled to contain 200 mg blister packs but actually contain 100 mg blister packs

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Impax Laboratories, Inc.

Impax Laboratories, Inc. has 5 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report