🔴 Safety Alert
American Regent, Inc. has issued a voluntary nationwide recall of one lot of Papaverine Hydrochloride Injection, USP, 60 mg/2 mL single-dose vials, according to a notice posted by the US Food and Drug Administration on 24 July 2026. The recall was initiated due to the presence of visible particulate matter, identified as glass fragments, in the affected vials. The company has recalled the product to the consumer level to prevent potential patient harm.
Key takeaways
- American Regent, Inc. is recalling one lot of Papaverine Hydrochloride Injection due to glass particulates in vials
- The FDA was notified on 24 July 2026 and classified the recall as a safety matter affecting injectable medication
- Healthcare providers should verify lot numbers and discontinue use of affected vials immediately
- Patients who received injections from the recalled lot should contact their healthcare provider for guidance
What triggered the recall
American Regent, Inc. identified glass particulate matter in vials of Papaverine Hydrochloride Injection, USP 60 mg/2 mL, a vasodilator medication commonly used for treating vascular disorders and erectile dysfunction. According to the FDA’s 24 July 2026 safety alert, the presence of visible glass fragments poses a risk of patient harm if the contaminated vials are used for injection.
The recall covers a single lot distributed nationwide in the United States. American Regent, Inc. initiated the recall voluntarily in coordination with regulatory review by the FDA. The company is notifying healthcare facilities, distributors, and pharmacies to remove affected vials from inventory and prevent further distribution.
Clinical safety implications
Injectable medications must meet strict sterility and particulate matter standards under FDA regulations. Glass particles in parenteral injections can cause vascular injury, tissue damage, inflammation, and potential systemic complications depending on the injection site and particle size. Healthcare providers should immediately discontinue use of any vial from the recalled lot and verify lot numbers before administering papaverine injections to patients.
The FDA’s Pharmacy & Prescribing safety guidelines recommend that clinicians inspect all injectable medications visually for particulates before administration and verify recall status through the FDA’s official recalls database. Patients who may have received injections from the affected lot should be contacted by their healthcare provider to assess for any adverse effects and determine whether follow-up clinical evaluation is needed.
American Regent, Inc. is recalling one lot of Papaverine Hydrochloride Injection, USP 60 mg/2 mL due to the presence of visible glass particulate matter that poses a safety risk to patients if injected.
— US Food and Drug Administration, Safety Alerts & Recalls (24 July 2026)
What this means
Frequently asked questions
What is papaverine hydrochloride used for?
Papaverine hydrochloride is a vasodilator medication used to treat various vascular conditions, including peripheral vascular disease and erectile dysfunction. It works by relaxing smooth muscle in blood vessels, improving blood flow. The FDA-approved injection form is administered directly into tissue or blood vessels under medical supervision.
How do I know if my medication was from the recalled lot?
Check the lot number on your vial or pharmacy receipt against the recalled lot number announced by American Regent, Inc. and posted on the FDA’s recalls page. If you received the injection in a clinical setting, contact the facility where you were treated and ask about the lot number of the papaverine used.
What should I do if I think I received an injection from the recalled lot?
Contact your healthcare provider immediately and inform them of your concern. Provide the date and location of the injection. Your provider can review your medical record, determine whether you received medication from the recalled lot, and examine you for any signs of complications. Most patients who receive contaminated injections do not develop symptoms, but medical evaluation is recommended for peace of mind and early detection of any rare complications.
The recall underscores the importance of robust post-market surveillance and quality control in injectable pharmaceutical manufacturing. Patients and healthcare providers should remain vigilant in monitoring product safety alerts from the FDA and promptly respond to recalls affecting medications they use. American Regent, Inc.’s swift voluntary recall action and FDA coordination exemplify effective communication to protect public health. For the latest information on this recall and other medication safety alerts, healthcare providers should regularly check the FDA’s Recalls, Market Withdrawals & Safety Alerts database.
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