Vigabatrin for Oral Solution — Class I drug recall D-0220-2024
Completed recall by InvaGen Pharmaceuticals, Inc., reported 2024-01-17, distributed nationwide. Defective Container: powder may leak out of the pouch
| Recall number | D-0220-2024 |
|---|---|
| Product type | Drug |
| Classification | Class I |
| Status | Completed |
| Voluntary or mandated | Voluntary |
| Recalling firm | InvaGen Pharmaceuticals, Inc., Central Islip, NY, United States |
| Recall initiated | 2023-11-17 |
| Classified | 2024-01-08 |
| Reported by FDA | 2024-01-17 |
| Distributed | Nationwide (US) |
| Quantity | 1,240 boxes |
| Reason classes | packaging |
| NDC | 69097-0964, 69097-0964-53 |
| Lot numbers | NB301030 |
| Expiration dates | 2025-03-31 |
Product
Vigabatrin for Oral Solution, USP 500 mg per packet, 50 packets per box, Rx Only, Manufactured by: InvaGen Pharmaceuticals, Inc., (a subsidiary of Cipla Ltd.), Hauppauge, NY, 11788, Manufactured for: Cipla USA, Inc., Warren, NJ 07059, NDC 69097-964-53
Reason for recall
Defective Container: powder may leak out of the pouch
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-0220-2024. 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.