FDA DrugsClass III
Fesoterodine Fumarate, Extended-release Tablets, 8 mg, 30 Tablets, Rx only, Manu...
Published: January 14, 2026Recall ID: D-0248-2026Category: drugsCountry: US
Reason for Recall / Hazard
Failed Impurities/Degradation Specifications: Due to levels of 'Diester Impurity' exceeding the specification limit.
Product Description & Identification
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
Additional Source Details
| Field | Value |
|---|---|
| City | Panchmahal |
| Openfda › Upc › 1 | 0362332176304 |
| Openfda › Upc › 2 | 0362332175307 |
| Openfda › Unii | EOS72165S7 |
| Openfda › Route | ORAL |
| Openfda › Rxcui › 1 | 810071 |
| Openfda › Rxcui › 2 | 810077 |
| Openfda › Spl id | 2fc9ba3f-2336-45b8-9020-bffc1298a6e0 |
| Openfda › Brand name | FESOTERODINE FUMARATE |
| Openfda › Spl set id | 299db62d-9658-4796-b449-657fa859c5cd |
| Openfda › Package ndc › 1 | 62332-175-30 |
| Openfda › Package ndc › 2 | 62332-175-90 |
| Openfda › Package ndc › 3 | 62332-175-91 |
| Openfda › Package ndc › 4 | 62332-175-10 |
| Openfda › Package ndc › 5 | 62332-176-30 |
| Openfda › Package ndc › 6 | 62332-176-90 |
| Openfda › Package ndc › 7 | 62332-176-91 |
| Openfda › Package ndc › 8 | 62332-176-10 |
| Openfda › Package ndc › 9 | 2405003360 |
| Openfda › Product ndc › 1 | 62332-175 |
| Openfda › Product ndc › 2 | 62332-176 |
| Openfda › Generic name | FESOTERODINE FUMARATE |
| Openfda › Product type | HUMAN PRESCRIPTION DRUG |
| Openfda › Substance name | FESOTERODINE FUMARATE |
| Openfda › Manufacturer name | Alembic Pharmaceuticals Inc. |
| Openfda › Application number | ANDA204973 |
| Openfda › Is original packager | true |
| Event id | 98119 |
| Address 1 | Formulation Division, Village Panelav, P.O. Tajpura, Near Baska, Taluka Halol |
| Code info | Lot# 2405003360, Exp Date: Jan 31, 2026 |
| Postal code | N/A |
| Report date | 20260114 |
| Product type | Drugs |
| Reason for recall | Failed Impurities/Degradation Specifications: Due to levels of 'Diester Impurity' exceeding the specification limit. |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20251216 |
| Center classification date | 20260102 |
Overview
- Recalling FirmAlembic Pharmaceuticals Limited
- StatusOngoing
- Risk LevelClass III
- DistributionUS Nationwide and PR.