Rasagiline Mesylate Tablets 1 mg — Class II drug recall D-0159-2023
Terminated recall by Ascend Laboratories, LLC, reported 2023-01-25, distributed in CA, FL, GA, IL, KY, LA, MI, MN…. Presence of Foreign Substance- A complaint was received of black spots/shiny metallic speck on the tablets.
| Recall number | D-0159-2023 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Ascend Laboratories, LLC, Parsippany, NJ, United States |
| Recall initiated | 2022-12-28 |
| Classified | 2023-01-16 |
| Reported by FDA | 2023-01-25 |
| Terminated | 2024-08-15 |
| Distributed | CA, FL, GA, IL, KY, LA, MI, MN, MS, NC, NJ, NY, OH, PA, PR, RI, TN, TX, WA, WI |
| Quantity | 12,192 bottles |
| NDC | 67877-0259, 67877-0259-30, 67877-0260, 67877-0260-30 |
| Lot numbers | 22140903 |
| Expiration dates | 2024-12-20 |
Product
Rasagiline Mesylate Tablets 1 mg; 30 tablets in HDPE bottle; Rx only; NDC 67877-260-30; Manufactured by Alkem Laboratories Ltd., India; Distributed by: Ascend Laboratories, LLC, Parsippany, NJ 07054
Reason for recall
Presence of Foreign Substance- A complaint was received of black spots/shiny metallic speck on the tablets.
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-0159-2023. 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.