American Regent, Inc. Issues Voluntary Nationwide Recall of One

Official notice

27 Jul 2026

MediumFDA

An official FDA notice concerns Papaverine Hydrochloride Injection, USP 60 mg/ 2 mL. The notice reports a health risk requiring medical assessment. Do not use the product and dispose of it as directed. Published 2026-07-27. Lots: 25202. Check the official notice for the complete list.

What to do now

Instructions for consumers are available in the official FDA notice.

Official notice

2026-07-27

The hazard

Health risk requiring medical assessment

How to check if you're affected

Compare the product name and identifiers below with the item you own. Follow the official notice if they match.

Lots

25202

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Affected products

Product 1

Papaverine Hydrochloride Injection, USP 60 mg/ 2 mL

Risk / hazard

Health risk requiring medical assessment

Where it was sold

The source does not list specific retailers. See the official notice for where affected products were sold.

Location 1

US · United States

Affected area 1

US · United States

Company & contacts

Brand

Manufacturer

Not provided

Phone

(800) 645-1706, 1-800-332-1088

Brand: Regent. Contact: American Regent, Inc.. Phone (800) 645-1706, 1-800-332-1088.

Source & status

Source

Tier

official

Category

HEALTH

App estimate

medium

Recall details

Source tier

official

Documents, notices & source

See the official notice and source documents for full details.

View full official notice
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