Recalls / Class III
Class IIID-0248-2026
Product
Fesoterodine Fumarate, Extended-release Tablets, 8 mg, 30 Tablets, Rx only, Manufactured by: Alembic Pharmaceuticals Limited, Panelav 389350, Gujarat, India, Manufactured for: Alembic Pharmaceuticals, Inc., Bedminster, NJ 07921, USA, NDC 62332-176-30
- 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# 2405003360, Exp Date: Jan 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.
- Type
- Voluntary: Firm initiated
- Address
- Formulation Division, Village Panelav, P.O. Tajpura, Near Baska, Taluka Halol, Panchmahal, N/A, India
Distribution
- Distribution pattern
- US Nationwide and PR.
Timeline
- Recall initiated
- 2025-12-16
- FDA classified
- 2026-01-02
- Posted by FDA
- 2026-01-14
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0248-2026. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.