Fesoterodine Fumarate recall: Impurity Out of Spec
Fesoterodine Fumarate, Extended-release Tablets, 4 mg, 30-count bottle, Rx only, Manufactured by: Alembic Pharmaceuticals Limited, Panelav 389350…
Why was Fesoterodine Fumarate recalled?
Failed Impurities/Degradation Specifications: Due to levels of 'Diester Impurity' exceeding the specification limit.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot # 2405006633, Exp Date: 03/31/2026
- Product
- Fesoterodine Fumarate, Extended-release Tablets, 4 mg, 30-count bottle, Rx only, Manufactured by: Alembic Pharmaceuticals Limited, Panelav 389350…
- Recalling firm
- Alembic Pharmaceuticals Limited
- Quantity
- 4,884 30-count bottles
- Distribution
- Nationwide in the USA.
- Recall date
- November 26, 2025
- Classification
- Class III
- Status
- Ongoing
- Agency
- FDA (drug)