Rufinamide Tablets — Class II drug recall D-1088-2023
Terminated recall by Aurobindo Pharma USA Inc., reported 2023-08-30, distributed nationwide. cGMP deviations: Batch was released prior to approval.
| Recall number | D-1088-2023 |
|---|---|
| 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 | 2023-07-21 |
| Classified | 2023-08-18 |
| Reported by FDA | 2023-08-30 |
| Terminated | 2024-02-26 |
| Distributed | Nationwide (US) |
| Quantity | 48 bottles |
| Reason classes | cgmp |
| NDC | 59651-0616, 59651-0616-08, 59651-0617, 59651-0617-08 |
| Lot numbers | RB4023002A |
| Expiration dates | 2025-02 |
Product
Rufinamide Tablets, USP 400 mg, packaged in 120-count bottle, Rx only, Distributed by: Aurobindo Pharma USA, Inc., 279 Princeton-Hightstown Road, East Windsor, NJ 08520, Made in India, NDC 59651-617-08
Reason for recall
cGMP deviations: Batch was released prior to approval.
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-1088-2023. 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.