Class III โ€” Low Risk

Low risk โ€” use of or exposure to this product is not likely to cause adverse health consequences.

Lamotrigine Tablets Recalled by AVKARE Inc. Due to Labeling: Label Error on Declared Strength

Date: July 20, 2022
Company: AVKARE 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 AVKARE Inc. directly.

Affected Products

Lamotrigine Tablets, USP 100 mg, 1000-count bottles, Rx Only, Manufactured for: AvKARE, Inc. Pulaski, TN 38478, NDC 42291-367-10, UPC 3 42291 36710 4

Quantity: 8328 bottles

Why Was This Recalled?

Labeling: Label Error on Declared Strength

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About AVKARE Inc.

AVKARE Inc. has 33 total recalls tracked by RecallDetector.

Related Recalls

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