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

Tirofiban Injection Recalled for Out-of-Specification Test Results

Eugia US LLC is recalling Tirofiban Hydrochloride Injection due to out-of-specification test results for related substances found during stability testing. The affected lot was distributed nationwide.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: This is an FDA Class II recall. The source text indicates out-of-specification test results without any reported illnesses, injuries, or deaths. The hazard is a potential quality defect detected during stability testing, making this a precautionary recall.

Plain-English summary

Eugia US LLC is recalling Tirofiban Hydrochloride Injection 5 mg/100 mL (50 mcg/mL) in 100 mL single-dose bags (NDC 55150-429-01 and 55150-430-01) nationwide. The recall affects Lot #3TF24002A with expiration date 11/30/2026, totaling 18,867 bags.

The recall was initiated because out-of-specification test results were obtained for related substances during a 3-month stability study conducted under long-term storage conditions. This indicates the product may not meet required quality standards.

Tirofiban is a prescription intravenous antiplatelet medication. Healthcare providers and patients currently using this medication should contact their pharmacy or healthcare provider for guidance. The drug is manufactured in India by Eugia US LLC, located in E. Windsor, New Jersey.

The recalled product

Product
TIROFIBAN (TIROFIBAN)
Brand
TIROFIBAN
Manufacturer
Eugia US LLC
Category
Drug — Injectable / Antiplatelet
Hazard
Affected units
18,867

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.

Part of a larger recall action

This product is one of 2 recalled by Eugia US LLC under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

Related recalls

Same brand · TIROFIBAN

Same manufacturer · Eugia US LLC

See all →