D-0248-2026 Class III Ongoing
FDA drug recall D-0248-2026 was initiated by Alembic Pharmaceuticals Limited on December 16, 2025 and is designated Class III. Reason for recall: Failed Impurities/Degradation Specifications: Due to levels of 'Diester Impurity' exceeding the specification limit. The recall status is ongoing.
Recall Details
- Product Type
- Drugs
- Report Date
- January 14, 2026
- Initiation Date
- December 16, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
Product Description
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
Reason for Recall
Failed Impurities/Degradation Specifications: Due to levels of 'Diester Impurity' exceeding the specification limit.
Distribution Pattern
US Nationwide and PR.
Code Information
Lot# 2405003360, Exp Date: Jan 31, 2026