CLASS II ONGOING Drug recall · Reported 7 May 2025 · FDA Enforcement Report
Tirofiban Hydrochloride Injection 5 mg recalled by Eugia US
Eugia US is recalling Tirofiban Hydrochloride Injection 5 mg/ (50 mcg/mL) single-dose container (bag), distributed nationwide in the US. The recall was initiated on 21 Apr 2025 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0389-2025
- FDA event ID
- 96718
- Recalling firm
- Eugia US, East Windsor, NJ
- Brand
- Tirofiban
- Manufacturer
- Eugia US LLC
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 21 Apr 2025
- FDA classified
- 25 Apr 2025
- Reported
- 7 May 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Drug class
- Injectable & IV Drugs
Timeline
| 21 Apr 2025 | Recall initiated by company | |
| 25 Apr 2025 | Classified by FDA | +4 days |
| 7 May 2025 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Out-of-Specification test results were obtained in at long term conditions during 3 month's stability study for related substances.
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
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
Where it was distributed
USA nationwide.
Questions about this recall
Is Tirofiban Hydrochloride Injection 5 mg/ (50 mcg/mL) single-dose container (bag) recalled?
Yes. Eugia US recalled Tirofiban Hydrochloride Injection 5 mg/ (50 mcg/mL) single-dose container (bag) on 21 Apr 2025. The recall is Class II and its status is Ongoing. Recall number D-0389-2025.
Why was it recalled?
Out-of-Specification test results were obtained in at long term conditions during 3 month's stability study for related substances.
Which lots are affected?
Lot #: 3TF24002A, Exp 11/30/2026
Where was it sold?
USA nationwide.
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Eugia US
All 17| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | Lidocaine HCl Injection, USP 2%, 40 mg recalled by Eugia USLidolog Kit | Eugia US | Other | Nationwide |
| Drug | CLASS II | Gentamicin Injection, USP, (Pediatric), 20 mg recalled by Eugia USGentamicin | Eugia US | Potency & Assay | Nationwide |
| Drug | CLASS II | Tirofiban Hydrochloride Injection 5 mg recalled by Eugia USTirofiban | Eugia US | Potency & Assay | Nationwide |
| Drug | CLASS II | Testosterone Cypionate Injection, USP, CIII, 200mg per mL recalledTestosterone Cypionate | Eugia US | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | medroxyPROGESTERone Acetate Injectable Suspension, USP, 150mg per mL recalledMedroxyprogesterone Acetate | Eugia US | Manufacturing (CGMP) Deviations | Nationwide |
Other Tirofiban recalls
All 2| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Tirofiban Hydrochloride Injection 5 mg recalled by Eugia USTirofiban | Eugia US | Potency & Assay | Nationwide |