FDA Drug recall D-0248-2026
Fesoterodine Fumarate, Extended-release Tablets, 8 mg, 30 Tablets, Rx only, Manufactured by: Alembic Pharmaceuticals Limited, Panelav 38935…
- FDA Drug
- Class III
- ongoing
- Published 2026-01-14
On 2026-01-14 the FDA classified a Class III recall of Fesoterodine Fumarate, Extended-release Tablets, 8 mg, 30 Tablets, Rx only, Manufactured by: Alembic Pharmaceuticals Limited, Panelav 38935… by Alembic Pharmaceuticals, citing failed Impurities/Degradation Specifications: Due to levels of 'Diester Impurity' exceeding the specification limit.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0248-2026 |
| Classification | Class III |
| Status | ongoing |
| Initiated | 2025-12-16 |
| Published | 2026-01-14 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Alembic Pharmaceuticals |
| Distribution | US |
Product
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
Failed Impurities/Degradation Specifications: Due to levels of 'Diester Impurity' exceeding the specification limit.
Identifiers
| ndc | 62332-175-30 |
|---|---|
| ndc | 62332-175-90 |
| ndc | 62332-175-91 |
| ndc | 62332-175-10 |
| ndc | 62332-176-30 |
| ndc | 62332-176-90 |
| ndc | 62332-176-91 |
| ndc | 62332-176-10 |
| ndc | 2405003360 |
| code_info | Lot# 2405003360, Exp Date: Jan 31, 2026 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0248-2026%22
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