American Regent, Inc. recalls Papaverine HCl Injection
- Recalling company
- 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
- Presence of Particulate Matter: Product contaminated with particulate matter identified as glass and/or paraformaldehyde
- Classification
- Class I – a reasonable probability that use will cause serious adverse health consequences or death
- Recall date
- Jul 24, 2026
- Reported
- Aug 26, 2026
- Distribution
- Nationwide within the U.S
- Status
- Ongoing
- Quantity
- 86,100 vials
- Lot / codes
- Lot #: 25202, Exp. Date: 11/30/2026.
- Company location
- Shirley, NY
- Recall type
- Voluntary: Firm initiated
- Recall number
- D-0800-2026
- Agency
- U.S. Food and Drug Administration (FDA)
View official FDA notice ↗ Search recall number D-0800-2026 in the FDA Enforcement Report. Also see FDA recall press releases.
If you use this product, check the lot, NDC or model number against the official notice and follow its instructions. Do not stop a prescribed medicine or remove a medical device without talking to your doctor or pharmacist. Report problems to FDA MedWatch. FoodRecallNow summarizes public FDA data and is not medical advice.