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.
The agency’s classification
FDA (Drugs): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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
- Affected units
- 8,328
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 brand · LAMOTRIGINE
- ModerateAvKARE Recalls Lamotrigine Tablets Due to Foreign Substance Presence
FDA (Drugs) · 2020-06-10
- SevereTaro Recalls Lamotrigine Tablets Due to Enalapril Maleate Contamination
FDA (Drugs) · 2020-02-19
- ModerateTorrent Pharma Recalls Lamotrigine Extended-Release Tablets for Dissolution Failure
FDA (Drugs) · 2018-09-26
- LowUnichem Recalls Lamotrigine Tablets With Incorrect Imprint
FDA (Drugs) · 2016-10-05
Same manufacturer · AVKARE Inc.
See all →- ModeratePhytonadione Tablets 5 mg Recalled Due to Failed Impurities Specification
FDA (Drugs) · 2021-06-23
- CriticalAvKare Recalls Trazodone Hydrochloride Tablets Due to Sildenafil Packaging Mix-Up
FDA (Drugs) · 2020-12-23
- ModerateAvKARE Recalls Sildenafil Tablets Due to Packaging Mix-Up with Trazodone
FDA (Drugs) · 2020-12-23
- ModerateAvKARE Recalls Mesalamine Tablets for Failed Dissolution Specifications
FDA (Drugs) · 2020-11-18
- HighAvKARE Recalls Metformin Hydrochloride Extended-Release Tablets Due to NDMA Impurity
FDA (Drugs) · 2020-06-24
Same hazard · mis labeling
See all →- ModerateEl Ruisenor De Mexico Recalls Almond Flour for Undeclared Allergen
FDA (Food) · 2026-10-28
- HighTrader Joe's Crispy Rice Milk Chocolate Bar Recalled for Undeclared Wheat
FDA (Food) · 2026-10-28
- ModerateEl Ruisenor De Mexico Recalls Black Sesame Seeds for Undeclared Allergen
FDA (Food) · 2026-10-28
- ModerateEl Ruisenor De Mexico Recalls Wheat Bran for Undeclared Wheat Allergen
FDA (Food) · 2026-10-28
- ModerateEl Ruisenor De Mexico Recalls Ground Shrimp for Undeclared Allergen
FDA (Food) · 2026-10-28
Similar recalls
- LowUnichem Recalls Lamotrigine Tablets With Incorrect Imprint
FDA (Drugs) · 2016-10-05
- ModerateAvKARE Recalls Lamotrigine Tablets Due to Foreign Substance Presence
FDA (Drugs) · 2020-06-10
- ModerateTorrent Pharma Recalls Lamotrigine Extended-Release Tablets for Dissolution Failure
FDA (Drugs) · 2018-09-26
- LowAurobindo Recalls Lisinopril Tablets Due to Labeling Error
FDA (Drugs) · 2013-06-05
- HighLevothyroxine Sodium Tablets Recalled Due to Potency Failures
FDA (Drugs) · 2024-12-18
- HighLevothyroxine sodium tablets recalled for potency failures nationwide
FDA (Drugs) · 2024-12-18