Carbamazepine tablets recalled for failed dissolution specifications
Torrent Pharma Inc. is recalling Carbamazepine 200 mg tablets nationwide because they failed to meet dissolution specifications, which means the tablets may not release the medication properly in the body.
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 FDA classified this as a Class II recall. The source text does not report any illness, injury, or hospitalization related to this defect. The hazard is that tablets may not dissolve properly, creating a potential risk of subtherapeutic dosing, but this is a precautionary recall without reported harm. This meets the rubric criterion for Moderate (2) severity.
Plain-English summary
Torrent Pharma Inc. is recalling Carbamazepine Tablets, USP 200 mg because the recalled batch failed to meet the required dissolution specifications. Dissolution specifications ensure that tablets break down and release medication at the appropriate rate in the body. When tablets fail these specifications, patients may not receive the intended dose of medication.
The recalled product is Carbamazepine Tablets, USP 200 mg in bottles of 100 tablets (NDC 13668-268-01), manufactured by Torrent Pharmaceuticals Ltd. in India for Torrent Pharma Inc. The affected batch is 4J11G002 with expiration date 08/2024. Approximately 15,336 bottles were distributed nationwide in the USA.
Carbamazepine is a prescription medication used to treat seizures, nerve pain, and mood disorders. Patients currently taking this recalled medication should not stop taking it without consulting their doctor, as stopping seizure medication suddenly can be dangerous. Patients should contact their healthcare provider to determine whether they received affected tablets and to discuss next steps.
Healthcare providers and patients who have this product should stop using it and return it to their pharmacy or call Torrent Pharma Inc. for instructions on disposal or replacement.
The recalled product
- Product
- CARBAMAZEPINE (CARBAMAZEPINE)
- Brand
- CARBAMAZEPINE
- Manufacturer
- Torrent Pharma Inc.
- Affected units
- 15,336
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)
- Batch: 4J11G002 Exp. 08/2024
Distribution
Distributed nationwide across the United States.
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