Skip to content
Back to recalls
Drug FDA Class II Ongoing Failed specifications

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

Eugia US LLC Published May 7, 2025

Risk level

Class II

May cause a temporary or reversible health problem; slight chance of serious harm.

Severity score 60/100

What should you do?

  • Check whether you have this product, using the lot codes, UPCs, and dates listed below.
  • Do not eat, serve, or sell the affected product.
  • Return it to the place of purchase for a refund, or throw it away in a sealed bag so people and animals can’t get to it.
  • Contact Eugia US LLC or your place of purchase with questions, and see the source record below for full details.
Reason for recall

Out-of-Specification test results were obtained in at long term conditions during 3 month's stability study for related substances.

Hazards

Failed Stability Specification - Related Substances · primary

Affected products (1)

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

TIROFIBAN · 18,867 bags

NDC: 55150-429, 55150-430, 55150-429-01, 55150-430-01
Code info: Lot #: 3TF24002A, Exp 11/30/2026

Affected areas

Nationwide

Timeline

  1. Initiated
    Apr 21, 2025
  2. Published
    May 7, 2025
Recall number
D-0389-2025
Agency
U.S. Food and Drug Administration
Country
US
Source data (openFDA JSON) About FDA enforcement reports

FDA records come from the openFDA drug enforcement-report dataset — the agency's full weekly enforcement list. Most entries are not issued as consumer press releases, so they won't appear on fda.gov/recalls or in a web search. The source record link above resolves this exact recall by its number.