⚠ RecallRadar📷 ScanGuidesOfficial U.S. recall notices, restated plainly

American Regent, Inc.: 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 Vial

DrugsSource: FDA (drug) · Date: 2026-08-26

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The text below is copied from the official FDA (drug) record. If anything differs, the official notice is correct.

Company / brand
American Regent, Inc.
Product
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.
Reason / hazard
Presence of Particulate Matter: Product contaminated with particulate matter identified as glass and/or paraformaldehyde
Classification
Class I
Status
Ongoing
Distribution / sold at
Nationwide within the U.S
Recall initiated
2026-07-24
Code info
Lot #: 25202, Exp. Date: 11/30/2026.
Product quantity
86,100 vials
Voluntary mandated
Voluntary: Firm initiated
City
Shirley
State
NY
Country
United States
Event id
99503
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