Class III
Ongoing
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
This recall is currently active, issued January 14, 2026. It was issued by Alembic Pharmaceuticals Limited.
- Company
- Alembic Pharmaceuticals Limited
- Recall Initiated
- December 16, 2025
- Posted
- January 14, 2026
- Recall Number
- D-0248-2026
- Voluntary / Mandated
- Voluntary: Firm initiated
- 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
US Nationwide and PR.
Lot / Code Info
Lot# 2405003360, Exp Date: Jan 31, 2026
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