FDAHealthOctober 10, 2025
Alembic Pharmaceuticals Limited — Fesoterodine Fumarate, Extended-release Tablets, 4 mg, 30-count bottle, Rx only, Manufactured by: Alembic Pharmaceuticals Limited, Panelav 389350, Gujarat, India, Man
⚠️ Failed Impurities/Degradation Specifications: Due to levels of 'Diester Impurity' exceeding the specification limit.
Is this relevant to me?
- Geography
- Nationwide
- Source agency
- FDA
- Category
- Health
- Published
- October 10, 2025
Nationwide in the USA.
What's affected?
- 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
- UPC
- 0362332176304
- Lot code
- 2405006633
Additional details
Lot # 2405006633, Exp Date: 03/31/2026
What should I do?
Recommended action
Class III recall. Voluntary: Firm initiated Quantity affected: 4,884 30-count bottles.
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