American Regent Papaverine Hydrochloride Injection recalled for glass particulate matter
What this means
American Regent identified glass and paraformaldehyde particles in one lot of Papaverine Hydrochloride Injection (Lot #25202), a prescription medication used to improve blood circulation and treat muscle spasms. The particles could cause local irritation, blood vessel blockage, and serious complications including stroke.
- If you have received this medication, stop using it immediately.
- Contact your doctor or healthcare provider right away, especially if you've already received an injection from this lot.
- Return the product to your pharmacy or healthcare facility, or discard it safely.
- Call American Regent Customer Service at 800-645-1706 (Monday–Thursday 8 a.m.–6 p.m. EST, Friday 8 a.m.–4 p.m. EST) for return or replacement.
Product photos
The agency's original wording
July 24, 2026 – Shirley, NY, American Regent, Inc. is conducting a nationwide voluntary recall of a single lot of Papaverine Hydrochloride Injection, USP, 60 mg/2 mL single dose vial to the consumer level. The product is being recalled due to the presence of particulate matter identified as glass an
Official notice
https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/american-regent-inc-issues-voluntary-nationwide-recall-one-lot-papaverine-hydrochloride-injectionMore American Regent recalls
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