Class III โ€” Low Risk

Low risk โ€” use of or exposure to this product is not likely to cause adverse health consequences.

Argatroban Injection Recalled by Pfizer Inc. Due to Failed Impurities/Degradation Specifications; Out of specification stability testing...

Date: August 28, 2018
Company: Pfizer Inc.
Status: Terminated
Source: FDA (Drug)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Pfizer Inc. directly.

Affected Products

Argatroban Injection, 250 mg/2.5 mL (100 mg/mL), 2.5 mL Single-use Vial, Rx only, Sterile, Manufactured for: Hospira, Inc, Lake Forest, IL 60045 USA. NDC: 0409-1140-01

Quantity: 1,580 vials

Why Was This Recalled?

Failed Impurities/Degradation Specifications; Out of specification stability testing results at the 18 month time point

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Pfizer Inc.

Pfizer Inc. has 114 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report