Fesoterodine tablets recalled after a diester impurity exceeded its specification limit
Alembic Pharmaceuticals is recalling 4,884 bottles of Fesoterodine Fumarate Extended-release Tablets 4 mg because Diester Impurity levels exceeded the specification limit.
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: Scored 2 because the FDA designated this Class III and the record cites a specification failure with no stated health consequence.
Plain-English summary
Fesoterodine Fumarate Extended-release Tablets, 4 mg, in 30-count bottles, manufactured by Alembic Pharmaceuticals in Panelav, Gujarat, India for Alembic Pharmaceuticals of Bedminster, New Jersey, are being recalled for failed impurities and degradation specifications.
The recall follows levels of Diester Impurity exceeding the specification limit.
The recall covers 4,884 30-count bottles from lot 2405006633, expiring 31 March 2026. The product was distributed nationwide in the United States. The FDA has classified the recall as Class III, its least serious category.
The enforcement record names the impurity specification failure without describing a health consequence, and reports no injuries. This is a prescription medicine, so patients holding the affected lot should contact their pharmacy or prescriber about a replacement rather than stopping treatment on their own.
The recalled product
- Product
- FESOTERODINE FUMARATE (FESOTERODINE FUMARATE)
- Brand
- FESOTERODINE FUMARATE
- Manufacturer
- Alembic Pharmaceuticals Limited
- Category
- Drug — Urological
- Hazard
- impurity
- out-of-specification
- class-iii
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 # 2405006633
- Exp Date: 03/31/2026
UPCs (2)
- 0362332176304
- 0362332175307
Distribution
Distributed nationwide across the United States.
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