The Recall Desk
HighFDA (Drugs)·D-0389-2025·Announced 2025-05-07

[pending] TIROFIBAN (TIROFIBAN)

Pending LLM rewrite. Source: FDA_DRUG D-0389-2025.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: Pending LLM scoring against the rubric.

Plain-English summary

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

The recalled product

Product
TIROFIBAN (TIROFIBAN)
Brand
TIROFIBAN
Manufacturer
Eugia US LLC

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (2)

  • Lot #: 3TF24002A
  • Exp 11/30/2026

UPCs (2)

  • 0355150430017
  • 0355150429011

Distribution

Distributed nationwide across the United States.