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FDA · Drugs ·

Papaverine HCl Injection recall

American Regent, Inc. recalled Papaverine HCl Injection on August 26, 2026 because of presence of Particulate Matter: Product contaminated with particulate matter identified as glass and/or paraformaldehyde. It was sold nationwide.

Why it was recalled

Presence of Particulate Matter: Product contaminated with particulate matter identified as glass and/or paraformaldehyde

What's recalled

Papaverine HCl Injection, USP, 60 mg/2 mL (30 mg/mL), packaged in a) 2mL Single-Dose Vial (NDC 0517-4002-01), and b) 25x2mL Single-Dose Vials (NDC 0517-4002-25), Rx Only, AMERICAN REGENT, INC., SHIRLEY, NY 11967.

Quantity: 86,100 vials

What to do

Check whether you have the product (match the lot numbers, dates or codes in the official notice). Stop using it, and return it or throw it away as the notice says.

Read the official FDA notice

Details

Company
American Regent, Inc., Shirley, NY
Date
Severity
Class I · most serious
the most serious: the product could cause serious health problems or death.
Where sold
Nationwide
Nationwide within the U.S
Status
Ongoing
Recall number
D-0800-2026
Source
U.S. Food and Drug Administration

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