Fesoterodine extended-release tablets recalled over a diester impurity above specification
Alembic Pharmaceuticals is recalling Fesoterodine Fumarate Extended-release Tablets, 8 mg, because levels of a diester impurity exceeded the specification limit.
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: Scored 2 under the rule that FDA Class III actions fall at 1 or 2: the record cites an impurity above specification with no stated clinical consequence.
Plain-English summary
Fesoterodine Fumarate Extended-release Tablets, 8 mg, 30 tablets, manufactured by Alembic Pharmaceuticals Limited of Panelav, Gujarat, India for Alembic Pharmaceuticals, Inc. of Bedminster, New Jersey, under NDC 62332-176-30, are being recalled.
The reason given in the enforcement record is failed impurities and degradation specifications, due to levels of the diester impurity exceeding the specification limit.
The recall covers lot 2405003360, expiry Jan 31, 2026. The record does not state a quantity. Distribution was nationwide in the United States and Puerto Rico. The FDA has classified the action as Class III, its least serious category.
Patients should not stop taking a prescribed medicine without speaking to their prescriber or pharmacist, who can confirm whether a specific bottle is affected and arrange a replacement.
The recalled product
- Product
- FESOTERODINE FUMARATE (FESOTERODINE FUMARATE)
- Brand
- FESOTERODINE FUMARATE
- Manufacturer
- Alembic Pharmaceuticals Limited
- Category
- Drug — Urological
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 (3)
- Lot# 2405003360
- Exp Date: Jan 31
- 2026
UPCs (2)
- 0362332176304
- 0362332175307
Distribution
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