D-0156-2026 Class III Ongoing
FDA drug recall D-0156-2026 was initiated by Alembic Pharmaceuticals Limited on Oct 10, 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. Affected quantity: 4,884 30-count bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- Nov 26, 2025
- Initiation Date
- Oct 10, 2025
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 4,884 30-count bottles
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.
Distribution Pattern
Nationwide in the USA.
Code Information
Lot # 2405006633, Exp Date: 03/31/2026
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0156-2026
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026