FDA-PR2026-07-24PACKAGING DEFECT

American Regent Papaverine Hydrochloride Injection recalled for glass particulate matter

GLASSOTHERNationwide distribution

American Regent Papaverine Injection recalled for glass particles

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

American Regent Inc. Papaverine Hydrochloride Injection 60mg/2mL
American Regent Inc. Papaverine Hydrochloride Injection 60mg/2mL
Hazard

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-injection

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