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.
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 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
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.
Related recalls
Same brand · FESOTERODINE FUMARATE
- ModerateFesoterodine extended-release tablets recalled over a diester impurity above specification
FDA (Drugs) · 2026-01-14
Same manufacturer · Alembic Pharmaceuticals Limited
See all →- HighDoxepin hydrochloride capsules exceed the interim nitrosamine impurity limit
FDA (Drugs) · 2025-08-13
- SevereCelecoxib Capsules 200 mg recalled for foreign tablets inside bottles
FDA (Drugs) · 2025-06-18
- ModerateBromfenac Ophthalmic Solution 0.09% Recalled for Failed Impurities Specifications
FDA (Drugs) · 2025-06-04
- SevereAlembic Pharmaceuticals Recalls Telmisartan Tablets Due to Labeling Error
FDA (Drugs) · 2021-04-14
- ModerateAlembic Recalls Aripiprazole Tablets Due to Labeling Error
FDA (Drugs) · 2020-07-01
Same hazard · impurity
See all →- ModerateAjanta Pharma Recalls Fluphenazine Hydrochloride Tablets Due to Impurity Failure
FDA (Drugs) · 2026-09-16
- ModerateHikma Recalls Ramipril Capsules Due to Process Impurity
FDA (Drugs) · 2026-09-02
- ModerateMedline Remedy Specialized Silicone Cream Recalled for Elevated Formaldehyde Levels
FDA (Drugs) · 2026-07-15
- SevereCinacalcet Hydrochloride Tablets Recalled for Elevated Impurity Levels
FDA (Drugs) · 2026-07-08
- HighDuloxetine 30mg delayed-release capsules exceed nitrosamine impurity interim limit
FDA (Drugs) · 2026-06-17
Similar recalls
- ModerateFesoterodine extended-release tablets recalled over a diester impurity above specification
FDA (Drugs) · 2026-01-14
- LowEzetimibe and Simvastatin Tablets Recalled for Failed Impurity Specifications
FDA (Drugs) · 2025-06-18
- LowDabigatran Etexilate Capsules Recalled Over Impurity Specification Failure
FDA (Drugs) · 2026-08-05
- ModeratePhytonadione Tablets 5 mg Recalled Due to Failed Impurities Specification
FDA (Drugs) · 2021-06-23
- HighFosfomycin Tromethamine Granules Recalled for Out-of-Specification Organic Impurities
FDA (Drugs) · 2024-02-28
- ModerateHeritage Pharmaceuticals Recalls Felodipine Extended Release Tablets Due to Impurities
FDA (Drugs) · 2020-12-02