Lamotrigine Tablets (AVKARE) – Strength Labeling Error (2022)
Class III: A situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences
Class III recall indicates unlikely adverse health consequences.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
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
Brand
AVKARE Inc.
Lot Codes / Batch Numbers
Lot #: 42581 Exp. 12/2024, 42484 Exp. 11/2024, 41204 Exp. 05/2024, 38723 Exp. 02/2023, 37623 Exp. 10/2022
Products Sold
Lot #: 42581 Exp. 12/2024; 42484 Exp. 11/2024; 41204 Exp. 05/2024; 38723 Exp. 02/2023; 37623 Exp. 10/2022
AVKARE Inc. is recalling Lamotrigine Tablets, USP 100 mg, 1000-count bottles, Rx Only, Manufactured for: AvKARE, Inc. Pulaski due to Labeling: Label Error on Declared Strength. This is a Class I recall, indicating a high risk of serious health consequences. Based on FDA drug enforcement report.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Labeling: Label Error on Declared Strength
Recommended Action
Per FDA guidance
Consumers should stop using the product and contact the recalling firm, their healthcare provider, or return it to the place of purchase.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 7, 2026