Lamotrigine Tablets Recalled for Label Strength Error
AVKARE Inc. is recalling 8,328 bottles of Lamotrigine Tablets, USP 100 mg nationwide due to a labeling error in the declared strength.
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: This is an FDA Class III recall for a minor labeling error regarding declared strength. Per the severity rubric, FDA Class III recalls are typically scored 1 or 2, with minor labeling errors classified as Moderate (2).
Plain-English summary
AVKARE Inc. is recalling 8,328 bottles of Lamotrigine Tablets, USP 100 mg (1000-count bottles) distributed nationwide in the United States.
The recall is due to a labeling error on the declared strength of the product. The affected lot numbers are 42581 (expiration 12/2024), 42484 (expiration 11/2024), 41204 (expiration 05/2024), 38723 (expiration 02/2023), and 37623 (expiration 10/2022). The product NDC is 42291-367-10.
Consumers or healthcare providers who have affected bottles should verify the lot number to determine if they have the recalled product.
The recalled product
- Product
- LAMOTRIGINE (LAMOTRIGINE)
- Brand
- LAMOTRIGINE
- Manufacturer
- AVKARE Inc.
- Category
- Drug
- Hazard
- mis-labeling
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 (5)
- Lot #: 42581 Exp. 12/2024
- 42484 Exp. 11/2024
- 41204 Exp. 05/2024
- 38723 Exp. 02/2023
- 37623 Exp. 10/2022
UPCs (2)
- 0342291368606
- 342291367104
Distribution
Distributed nationwide across the United States.
Related recalls
Same category
- CriticalWarfarin Tablets Recalled After Mix-Up Between 2.5 mg and 5 mg Strengths
FDA (Drugs) · 2026-07-21
- HighBeak & Skiff Alcohol Antiseptic Sanitizer recalled for acetaldehyde contamination
FDA (Drugs) · 2026-06-17
- SevereCIMZIA injection recalled due to lack of sterility assurance
FDA (Drugs) · 2026-05-27
- SevereAtomoxetine Capsules Recalled Due to Labeling Mix-Up Error
FDA (Drugs) · 2026-05-27
- LowPrimidone Tablets Recalled Due to Cross-Contamination with Acemetacin
FDA (Drugs) · 2026-05-27