FDA Drug recall D-1171-2023
Rasagiline Tablets 0.5mg, 30-count bottle, Rx only, Mylan Pharmaceuticals Inc
- FDA Drug
- Class II
- terminated
- Published 2023-09-27
On 2023-09-27 the FDA classified a Class II recall of Rasagiline Tablets 0.5mg, 30-count bottle, Rx only, Mylan Pharmaceuticals Inc by Aurobindo Pharma Usa, citing failed dissolution specifications - results obtained were below spec average.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-1171-2023 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2023-08-02 |
| Published | 2023-09-27 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Aurobindo Pharma Usa |
| Distribution | US |
Product
Rasagiline Tablets 0.5mg, 30-count bottle, Rx only, Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A., NDC 0378-1270-93
Reason
Failed dissolution specifications - results obtained were below spec average.
Identifiers
| code_info | Lot #: 3112444, Exp 8/2023 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1171-2023%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.