FDAFDA · Food and drugs·Recall number D-0800-2026
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.
Published August 26, 2026 · Recall initiated: July 24, 2026
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Presence of Particulate Matter: Product contaminated with particulate matter identified as glass and/or paraformaldehyde
What to do
Voluntary: Firm initiated · Press Release
Recall details
- Brand
- PAPAVERINE HYDROCHLORIDE
- Manufacturer
- American Regent, Inc.
- Distributor
- Nationwide within the U.S
- UPC
- 0305174002257
- Lot
- Lot #: 25202, Exp. Date: 11/30/2026.
- Risk classification
- Class I
- Area (FDA)
- drug
- Country
- United States
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