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
Reported: November 26, 2025 Initiated: October 10, 2025 #D-0156-2026
Product Description
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
Reason for Recall
Failed Impurities/Degradation Specifications: Due to levels of 'Diester Impurity' exceeding the specification limit.
Details
- Recalling Firm
- Alembic Pharmaceuticals Limited
- Units Affected
- 4,884 30-count bottles
- Distribution
- Nationwide in the USA.
- Location
- Panchmahal
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Alembic Pharmaceuticals Limited. Units affected: 4,884 30-count bottles.
Why was this product recalled? ▼
Failed Impurities/Degradation Specifications: Due to levels of 'Diester Impurity' exceeding the specification limit.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on November 26, 2025. Severity: Low. Recall number: D-0156-2026.
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