Fesoterodine Fumarate Recall: Alembic 4 mg ER Tablets
Alembic Pharmaceuticals Limited recalls Fesoterodine Fumarate Extended-release Tablets 4 mg, 30-count bottles (Rx only). The recall is due to Diester Impurity levels exceeding the specification limit. About 4,884 bottles have been distributed nationwide in the USA; the affected lot is Lot 2405006633 with an expiration date 03/31/2026.
| Brand | Alembic Pharmaceuticals Limited |
|---|---|
| Product | 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 | Failed Impurities/Degradation Specifications: Due to levels of 'Diester Impurity' exceeding the specification limit. |
| Severity | low |
| Units affected | 4,884 30-count bottles |
| Distribution | Nationwide in the USA. |
| Agency | FDA |
WHAT YOU SHOULD DO
- Check if you have the recalled lot (Lot 2405006633) and the expiration date 03/31/2026.
- If you have the recalled product, discontinue use and contact your pharmacist or prescriber for guidance.
- Return or dispose of the product according to your pharmacy's or local guidelines, and contact Alembic Pharmaceuticals for instructions.
- If you have experienced health issues or adverse effects, report them to your healthcare provider and the FDA MedWatch program.
How to identify the recalled item
| Lot / date codes | Lot # 2405006633, Exp Date: 03/31/2026 |
|---|---|
| Lot / date codes | Lot # 7240184, 7240185, 7240186, 7240187, Exp Date: 3/31/2026; Lot # 7240278, Exp Date: 5/31/2026. |
These are the identifiers FDA published for this recall. Most recall notices list no UPC or model number at all — if the code on your item is not shown here, that does not mean the item is excluded. Check the official notice, or contact the company.
This is an automatically maintained record of an official recall notice. Details can change; always follow the official notice linked above. See all records in the Recall Database.