Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Aminophylline Injection Recalled by Pfizer Inc. Due to Presence of Particulate Matter: A complaint was received...

Date: September 27, 2022
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

Aminophylline Injection, USP 250 mg/10 mL (25 mg/mL) 25x10 mL Single-dose vial, Rx only, Distributed by Hospira, Inc. Lake Forest, IL 60045 USA. NDC 0409-5921-16 (vial) 0409-5921-01 (carton)

Quantity: 103,150 10 mL vials

Why Was This Recalled?

Presence of Particulate Matter: A complaint was received for the presence of a hair in one vial.

Where Was This Sold?

Distributed in the United States and Puerto Rico.

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