Rasagiline Tablets 0 — Class II drug recall D-1171-2023
Terminated recall by Aurobindo Pharma USA Inc., reported 2023-09-27, distributed nationwide. Failed dissolution specifications - results obtained were below spec average.
| Recall number | D-1171-2023 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Aurobindo Pharma USA Inc., East Windsor, NJ, United States |
| Recall initiated | 2023-08-02 |
| Classified | 2023-09-18 |
| Reported by FDA | 2023-09-27 |
| Terminated | 2024-08-19 |
| Distributed | Nationwide (US) |
| Quantity | 9,890 bottles |
| Reason classes | specification failure |
| NDC | 00378-1270-93 |
| Lot numbers | 3112444 |
| Expiration dates | 2023-08 |
Product
Rasagiline Tablets 0.5mg, 30-count bottle, Rx only, Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A., NDC 0378-1270-93
Reason for recall
Failed dissolution specifications - results obtained were below spec average.
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-1171-2023. 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.