Tirofiban Hydrochloride Injection 12.5 mg/250 mL (50 mcg/mL) recall
FDA recall D-0390-2025 · initiated Apr 21, 2025
Eugia US LLC recalled Tirofiban Hydrochloride Injection 12.5 mg/250 mL (50 mcg/mL) in Apr 2025 — an FDA Class II recall (D-0390-2025) because Out-of-Specification test results were obtained in at long term conditions during 3 month's stability study for related substances.
May cause temporary or medically reversible harm; low probability of serious harm.
Why it was recalled
Out-of-Specification test results were obtained in at long term conditions during 3 month's stability study for related substances.
Wrong strength, or it did not keep
The product did not contain what the label promised, or stopped meeting specification before its expiry date. Under-strength medicine can mean an untreated condition.
This is a manufacturing or quality failure, not a finding that the medicine is unsafe to take — across every recall we hold, none was issued for that reason. It does not mean the batch was harmless.
Is your product affected? Check the lot number
A recall covers only specific lots. Find the lot number and expiration date on your package and compare them to the affected codes below — if yours is not listed, it was not part of this recall.
Details
- Product
- Tirofiban Hydrochloride Injection 12.5 mg/250 mL (50 mcg/mL), 250 mL single-dose container (bag), Rx only, Manufactured in India for: Eugia U.S. LLC, 279 Princeton-Hightstown Rd., E. Windsor, NJ 08520, NDC 55150-430-01
- Recalling company
- Eugia Pharma
- Classification
- Class II
- Status
- Ongoing
- Type
- Voluntary: Firm initiated
- Distribution
- USA nationwide.
- Initiated
- Apr 21, 2025
- FDA report date
- May 7, 2025
Frequently asked
- Was Tirofiban Hydrochloride Injection 12.5 mg/250 mL (50 mcg/mL) recalled?
- Eugia US LLC recalled Tirofiban Hydrochloride Injection 12.5 mg/250 mL (50 mcg/mL) in Apr 2025 — an FDA Class II recall (D-0390-2025) because Out-of-Specification test results were obtained in at long term conditions during 3 month's stability study for related substances. May cause temporary or medically reversible harm; low probability of serious harm.
- Why was Tirofiban Hydrochloride Injection 12.5 mg/250 mL (50 mcg/mL) recalled?
- Per the FDA enforcement record, the reason for recall D-0390-2025 was: Out-of-Specification test results were obtained in at long term conditions during 3 month's stability study for related substances.
- Is a recalled Tirofiban Hydrochloride Injection 12.5 mg/250 mL (50 mcg/mL) dangerous to take?
- An FDA recall removes specific lots from the market for a defined reason and does not by itself mean the medicine is unsafe for everyone — your specific lot may never have been affected. May cause temporary or medically reversible harm; low probability of serious harm. Check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This reproduces public FDA data and is not medical advice.
- Which lots of Tirofiban Hydrochloride Injection 12.5 mg/250 mL (50 mcg/mL) are affected?
- Distributed: USA nationwide.. The recall covers these lots — Lot# : 3TF24001, Exp 3/31/2026. Check the lot number and expiration date on your package against this list; if yours is not listed, it was not part of recall D-0390-2025.