Torrent Pharma Recalls Lamotrigine Extended-Release Tablets for Dissolution Failure
Torrent Pharma Inc. is recalling 15,384 bottles of Lamotrigine Extended-Release Tablets, 200 mg, because they failed dissolution testing during stability checks.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
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: The recall is classified as FDA Class II, which corresponds to a moderate severity score of 2. The hazard involves a quality control failure (dissolution) without reported injuries or illnesses, fitting the criteria for moderate risk.
Plain-English summary
Torrent Pharma Inc. is recalling 15,384 bottles of Lamotrigine Extended-Release Tablets, USP, 200 mg. The affected product is identified by Lot BFR5D002 with an expiration date of 11-2019. The product was distributed nationwide in the United States.
The recall was initiated because the tablets failed to meet dissolution specifications during stability testing. Specifically, the product was out of specification for the dissolution test at the Buffer Stage at the 5-hour time point. This failure indicates that the tablets may not release the medication as intended.
Consumers who have this product should stop using it and contact their healthcare provider or pharmacist for guidance. The product is prescription-only, so patients should consult their prescriber regarding alternative treatment options.
The recalled product
- Product
- LAMOTRIGINE (LAMOTRIGINE)
- Brand
- LAMOTRIGINE
- Manufacturer
- Torrent Pharma 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 (1)
- Lot: BFR5D002 EXP 11-2019
UPCs (3)
- 0313668342307
- 0313668341300
- 0313668340303
Distribution
Distributed nationwide across the United States.
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