UnratedDrug recall · FDA · Published April 21, 2025
Eugia recalls Tirofiban injection: Out-of-spec related substances in stability testing
Eugia US LLC recalls Tirofiban Hydrochloride Injection 12.5 mg/250 mL due to out-of-spec related substances in stability testing. This medication is prescription-only and sold in single-dose containers.
“Eugia recalls Tirofiban injection: Out-of-spec related substances in stability testing.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/32123-eugia-recalls-tirofiban-injection-out-of-spec-related-substances-in. Based on FDA recall #D-0390-2025 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0390-2025%22&limit=1).
Eugia US LLC recalled Tirofiban Hydrochloride Injection 12.5 mg/250 mL nationwide due to out-of-specification test results for related substances, the FDA said on April 21, 2025.
How to tell if you have it
Brand: Eugia
Product: Tirofiban Hydrochloride Injection 12.5 mg/250 mL (50 mcg/mL)
Container: 250 mL single-dose container (bag)
NDC: 55150-430-01
Lot#: 3TF24001
Expiration: 3/31/2026
The hazard
Out-of-specification test results were obtained in at long term conditions during a 3-month stability study for related substances.
Context
GovInfoNow's records show Eugia US LLC has 14 other recalls on record since December 28, 2022. Recent similar recalls include Eugia's May 18, 2026 recall of Lidocaine injection due to label scanning issues and its May 29, 2025 recall of Gentamicin Injection due to stability failure. Other recent recalls of similar products include Safecor Health's August 13, 2026 Fluphenazine Elixir Recall for failed stability specifications and Somerset Therapeutics' November 26, 2025 Cisatracurium Besylate Injection Recall for subpotent product risk.
How to tell if you have this one
Check for the product name Tirofiban Hydrochloride Injection 12.5 mg/250 mL (single-dose bag) with lot number 3TF24001. This medication is prescription-only and manufactured in India for Eugia US LLC.
Brand
Eugia
Category
Drug
FDA recall event · 2 products
All 2 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
Classification
Class II
Status
Ongoing
Distribution
USA nationwide.
NDC
55150-429-01, 55150-430-01
Recall number
Product, codes & lots
Quantity
D-0389-2025
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; Lot #: 3TF24002A, Exp 11/30/2026
18,867 bags
D-0390-2025
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; Lot# : 3TF24001, Exp 3/31/2026
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Based on the official FDA remedy
What to do — step by step
Check Product Details
Look for the lot number 3TF24001 on the container to confirm if it's affected.
Where it went and when
Where it was distributed
Distributed nationwide.
Nationwide
Not listed
FDA distribution: “USA nationwide.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA published this recall 16 days after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #D-0390-2025 (April 21, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0390-2025 to see it in context.
Plain-language summary written by qwen3:4b on August 17, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.