D-0248-2026 Class III Ongoing
FDA drug recall D-0248-2026 was initiated by Alembic Pharmaceuticals Limited on Dec 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
- Jan 14, 2026
- Initiation Date
- Dec 16, 2025
- Voluntary/Mandated
- Voluntary: Firm initiated
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
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0248-2026
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026