Recalls / Class III
Class IIID-0156-2026
Product
Fesoterodine Fumarate, Extended-release Tablets, 4 mg, 30-count bottle, Rx only, Manufactured by: Alembic Pharmaceuticals Limited, Panelav 389350, Gujarat, India, Manufactured for: Alembic Pharmaceuticals, Inc., Bedminster, NJ 07921, USA, NDC 62332-175-30
- Brand name
- Fesoterodine Fumarate
- Generic name
- Fesoterodine Fumarate
- Active ingredient
- Fesoterodine Fumarate
- Route
- Oral
- NDCs
- 62332-175, 62332-176
- FDA application
- ANDA204973
- Affected lot / code info
- Lot # 2405006633, Exp Date: 03/31/2026
Why it was recalled
Failed Impurities/Degradation Specifications: Due to levels of 'Diester Impurity' exceeding the specification limit.
Recalling firm
- Firm
- Alembic Pharmaceuticals Limited
- Manufacturer
- Alembic Pharmaceuticals Inc.
- Notification channel
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Type
- Voluntary: Firm initiated
- Address
- Formulation Division, Village Panelav, P.O. Tajpura, Near Baska, Taluka Halol, Panchmahal, N/A, India
Distribution
- Quantity
- 4,884 30-count bottles
- Distribution pattern
- Nationwide in the USA.
Timeline
- Recall initiated
- 2025-10-10
- FDA classified
- 2025-11-14
- Posted by FDA
- 2025-11-26
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0156-2026. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.