FDA Drug recall D-0156-2026
Fesoterodine Fumarate, Extended-release Tablets, 4 mg, 30-count bottle, Rx only, Manufactured by: Alembic Pharmaceuticals Limited, Panelav…
- FDA Drug
- Class III
- ongoing
- Published 2025-11-26
On 2025-11-26 the FDA classified a Class III recall of Fesoterodine Fumarate, Extended-release Tablets, 4 mg, 30-count bottle, Rx only, Manufactured by: Alembic Pharmaceuticals Limited, Panelav… 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-0156-2026 |
| Classification | Class III |
| Status | ongoing |
| Initiated | 2025-10-10 |
| Published | 2025-11-26 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Alembic Pharmaceuticals |
| Distribution | US |
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.
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 | 2405006633 |
| code_info | Lot # 2405006633, Exp Date: 03/31/2026 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: ongoing.
Other recalls by Alembic Pharmaceuticals
- Fesoterodine Fumarate, Extended-release Tablets, 8 mg, 30 Tablets, Rx only, Manufactured by: Alembic Pharmaceuticals Limited, Panelav 38935…
FDA Drug · Class III · 2026-01-14 · Alembic Pharmaceuticals - Doxepin Hydrochloride Capsules, USP, 10 mg, 100 Capsules, Rx only, Manufactured by: Alembic Pharmaceuticals Limited, Panela v 389350, Gujar…
FDA Drug · Class II · 2025-08-13 · Alembic Pharmaceuticals - Celecoxib Capsules, 200 mg, 500-count bottle, Rx only, Manufactured by: Alembic Pharmaceuticals Limited (Formulation Division), Panelav 389…
FDA Drug · Class II · 2025-06-18 · Alembic Pharmaceuticals - Bromfenac Ophthalmic Solution 0.09%, 1.7 mL bottle, Rx only, Sterile, Manufactured for: Alembic Pharmaceuticals, Inc., Bedminster, NJ 07921…
FDA Drug · Class II · 2025-06-04 · Alembic Pharmaceuticals - Tobramycin Opthalmic Solution USP, 0.3%, 5mL bottle, Rx only, Manufactured for: Alembic Pharmaceuticals, Bedminster, NJ 07921, USA, NDC 623…
FDA Drug · Class III · 2023-08-23 · Alembic Pharmaceuticals
All Alembic Pharmaceuticals recalls
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0156-2026%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.