FDA: American Regent, Inc. Issues Voluntary Nationwide Recall of One Lot of Papaverine Hydrochloride Injection, USP 60 mg/2mL

Published: 07/27/2026

Sources:
  • Food and Drug Administration
Relevant To:
  • Ambulatory Surgical Centers,
  • Rural Emergency Hospitals,
  • Urgent Care,
  • Medical Office,
  • Critical Access Hospitals,
  • Hospitals,
  • Ambulatory Care,
  • Office-Based Surgery,
  • Pharmacy,
  • Rural Health Clinics

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 and/or paraformaldehyde.

  • Papaverine is a prescription medication that relaxes smooth muscles and widens blood vessels.
  • Papaverine is primarily used to treat visceral spasms, poor blood circulation, and erectile dysfunction.
    • …

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