Tirofiban Hydrochloride Injection 5 mg/100 mL — Class II drug recall D-0389-2025
Ongoing recall by Eugia US LLC, reported 2025-05-07, distributed nationwide. Out-of-Specification test results were obtained in at long term conditions during 3 month's stability study fo
| Recall number | D-0389-2025 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Eugia US LLC, East Windsor, NJ, United States |
| Recall initiated | 2025-04-21 |
| Classified | 2025-04-25 |
| Reported by FDA | 2025-05-07 |
| Distributed | Nationwide (US) |
| Quantity | 18,867 bags |
| Reason classes | specification failure |
| NDC | 55150-0429, 55150-0429-01, 55150-0430, 55150-0430-01 |
| Lot numbers | 3TF24002A |
| Expiration dates | 2026-11-30 |
Product
Tirofiban Hydrochloride Injection 5 mg/100 mL (50 mcg/mL), 100 mL single-dose container (bag), Rx only, Manufactured in India for: Eugia U.S. LLC, 279 Princeton-Hightstown Rd., E. Windsor, NJ 08520, NDC 55150-429-01
Reason for recall
Out-of-Specification test results were obtained in at long term conditions during 3 month's stability study for related substances.
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-0389-2025. 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.