Papaverine Hydrochloride Injection, Solution
FDA Recall NDC 0517-4002
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 1 recorded enforcement report(s) associated with Papaverine Hydrochloride (NDC 0517-4002). A significant event, classified as Class I, was initiated on Jul 24, 2026 by American Regent, Inc.. The reported reason for this action was: "Presence of Particulate Matter: Product contaminated with particulate matter identified as glass and/or paraformaldehyde"
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
Reported Recall Events
Class I Ongoing
Presence of Particulate Matter: Product contaminated with particulate matter identified as glass and/or paraformaldehyde
Jul 24, 2026
Aug 26, 2026
86,100 vials
Recall Profile & Regulatory Data
Event ID
99503
Classification
Class I
Enforcement Status
Ongoing
Recalling Firm
American Regent, Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide within the U.S
Product Description
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.
Batch or Lot Expiration Information
Lot# : 25202, Exp. Date: 11/30/2026.
Affected Packages Involved in this Recall
0517-4002-01Product
0517-4002-25Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
