Taro Recalls Lamotrigine Tablets Due to Enalapril Maleate Contamination
Taro Pharmaceuticals is recalling Lamotrigine Tablets 100 mg because they were cross-contaminated with enalapril maleate. The affected lot was distributed nationwide in the U.S. and Puerto Rico.
The agency’s classification
FDA (Drugs): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classified this recall as Class I, which mandates a minimum severity score of 4 per the rubric. The hazard involves cross-contamination with an unrelated drug, posing a significant risk of adverse health consequences.
Plain-English summary
Taro Pharmaceuticals U.S.A., Inc. is recalling Lamotrigine Tablets, USP, 100 mg, 100-count bottles. The recall is due to cross-contamination with enalapril maleate. The specific product affected is identified by Lot # 331771 with an expiration date of June 2021. The product is manufactured by Taro Pharmaceutical Industries Ltd. in Haifa Bay, Israel, and distributed by Taro Pharmaceuticals U.S.A., Inc. in Hawthorne, NY.
The affected medication was distributed nationwide in the United States and Puerto Rico. Lamotrigine is a prescription medication used as an anti-epileptic agent and mood stabilizer. The presence of enalapril maleate, an unrelated medication, constitutes a cross-contamination hazard.
Consumers should check their medication bottles for the specific lot number and expiration date listed above. If the product matches the recalled lot, consumers should stop using it and contact their healthcare provider or pharmacist for guidance on obtaining a replacement.
The recalled product
- Product
- LAMOTRIGINE (LAMOTRIGINE)
- Brand
- LAMOTRIGINE
- Manufacturer
- Taro Pharmaceuticals U.S.A., Inc.
- Category
- Drug — Prescription Medication
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 (2)
- Lot #: 331771
- Exp. June 2021
UPCs (4)
- 0351672413019
- 0351672413347
- 0351672413248
- 0351672413118
Distribution
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