Class III
Ongoing
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
This recall is currently active, issued November 26, 2025. It was issued by Alembic Pharmaceuticals Limited.
- Company
- Alembic Pharmaceuticals Limited
- Recall Initiated
- October 10, 2025
- Posted
- November 26, 2025
- Recall Number
- D-0156-2026
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 4,884 30-count bottles
- Firm Location
- Panchmahal, India
- Official Source
- View on FDA website ↗
Reason for Recall
Failed Impurities/Degradation Specifications: Due to levels of 'Diester Impurity' exceeding the specification limit.
Distribution
Nationwide in the USA.
Lot / Code Info
Lot # 2405006633, Exp Date: 03/31/2026
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