FDA-Drug2026-08-26Class IPROCESSING DEFECT
American Regent Papaverine HCl Injection recalled for glass and paraformaldehyde contamination
What this means
American Regent's Papaverine HCl Injection (60 mg/2 mL) has been found to contain particulate matter identified as glass and/or paraformaldehyde. The contamination affects one lot (25202, expiring 11/30/2026) distributed nationwide. This is a prescription injectable medication used to treat certain circulatory conditions.
- If you have received or administered this medication from lot 25202, do not use it.
- Contact your pharmacy or healthcare provider immediately if you have questions about whether you received an affected batch.
- Report any adverse events or concerns to the FDA MedWatch program or your healthcare provider.
The agency's original wording
Hazard
Presence of Particulate Matter: Product contaminated with particulate matter identified as glass and/or paraformaldehyde
Intended for
Adults
Illnesses reported
None reported
Sold states
Nationwide within the U.S
Affected count
86,100 vials
Manufactured in
5 Ramsay Rd, Shirley, NY, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0800-2026More American Regent recalls
- FDA-Drug2026-09-16American Regent epinephrine injection recalled for particulate matter and sterility concerns
- FDA-PR2026-09-03American Regent epinephrine injection recalled for particulate matter and sterility concerns
- FDA-Drug2026-08-26American Regent Cyanocobalamin injection recalled for particulate contamination
- FDA-Drug2026-08-26American Regent Tralement trace elements injection recalled for particulate contamination
- FDA-Drug2026-08-26American Regent aminocaproic acid injection recalled for particulate contamination
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