Fesoterodine Fumarate — Class III drug recall D-0156-2026
Ongoing recall by Alembic Pharmaceuticals Limited, reported 2025-11-26, distributed nationwide. Failed Impurities/Degradation Specifications: Due to levels of 'Diester Impurity' exceeding the specification
| Recall number | D-0156-2026 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Alembic Pharmaceuticals Limited, Panchmahal, India |
| Recall initiated | 2025-10-10 |
| Classified | 2025-11-14 |
| Reported by FDA | 2025-11-26 |
| Distributed | Nationwide (US) |
| Reason classes | specification failure |
| NDC | 62332-0175, 62332-0175-10, 62332-0175-30, 62332-0175-90, 62332-0175-91, 62332-0176, 62332-0176-10, 62332-0176-30, 62332-0176-90, 62332-0176-91 |
| Lot numbers | 2405006633 |
| Expiration dates | 2026-03-31 |
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 for recall
Failed Impurities/Degradation Specifications: Due to levels of 'Diester Impurity' exceeding the specification limit.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0156-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.