FDA Recall: American Regent, Inc. Papaverine Hydrochloride Injection, USP
Source: FDA
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FDA Recall: American Regent, Inc. Papaverine Hydrochloride Injection, USP

American Regent, Inc. • July 27, 2026

American Regent Papaverine Hydrochloride Injection Recall: Glass and Paraformaldehyde Contamination

American Regent, Inc. is voluntarily recalling one lot of its prescription-only Papaverine Hydrochloride Injection, USP (60 mg/2 mL) after routine inspection revealed visible glass and paraformaldehyde particles in some vials. Healthcare professionals and patients should immediately quarantine the affected product, confirm the National Drug Code (NDC) and lot number, and follow the return instructions below.

Key Facts About the American Regent Papaverine Recall

  • Product: Papaverine Hydrochloride Injection, USP 60 mg/2 mL (single-dose vial)
  • Manufacturer: American Regent, Inc., Shirley, NY
  • Recall Trigger: Presence of glass and/or paraformaldehyde particles
  • Lot Number: 25202
  • NDC: 0517-4002-25
  • Expiration: 11/30/2026
  • Distribution: Nationwide (USA) beginning 09/30/2025
  • Recall Announced: July 24, 2026 (FDA posted July 27, 2026)

Sources

Health Risks of Contaminated Papaverine Vials

Injection of solutions containing particulate matter can cause:

  • Local irritation, inflammation, or swelling at the injection site
  • Blockage of blood vessels in the heart, lungs, or brain, which could lead to stroke, pulmonary embolism, or cardiac complications
  • Life-threatening outcomes in patients with existing cardiovascular or pulmonary disease

No injuries had been reported at the time of the recall, but the potential severity of these risks requires immediate product removal.

How to Handle Recalled American Regent Papaverine Vials

  1. Identify inventory labeled NDC 0517-4002-25, lot 25202.
  2. Stop using or dispensing the product immediately.
  3. Return vials to the distributor or dispose of them per facility protocol.
  4. Contact American Regent Customer Service at 800-645-1706 for return, replacement, or credit (Mon–Thu 8 AM–6 PM ET; Fri 8 AM–4 PM ET).
  5. Report adverse events to American Regent Pharmacovigilance (800-734-9236 or pv@americanregent.com) and to FDA MedWatch (online form).

Official Image From the Recall

Recalled American Regent Papaverine Hydrochloride Injection 60 mg/2 mL vial
Source: FDA

Frequently Asked Questions About the American Regent Papaverine Recall

1. How do I confirm my vial is part of the American Regent Papaverine Hydrochloride recall?

Check the vial label for NDC 0517-4002-25 and lot 25202 with an expiration date of 11/30/2026. Only this specific lot is affected.

2. Can I continue using American Regent Papaverine if no particles are visible?

No. Particulates may settle at the bottom and escape detection until the vial is agitated. Both the FDA and American Regent direct users to stop using and return all product from the recalled lot.

3. What should I do if a patient received American Regent Papaverine from lot 25202?

Closely monitor the patient for local irritation, respiratory distress, or neurological symptoms. Report any adverse events to American Regent Pharmacovigilance and FDA MedWatch.

4. Will American Regent replace recalled Papaverine Hydrochloride vials?

Yes. Contact American Regent Customer Service at 800-645-1706 to arrange for return and credit or replacement.

5. Is there an alternative to American Regent Papaverine during the recall?

Only one lot is affected, and American Regent is working to replenish supply. In the interim, check with your distributor or pharmacy for equivalent papaverine products from other manufacturers.

6. Where can I report side effects linked to American Regent Papaverine Injection?

Report side effects to American Regent at 800-734-9236 or pv@americanregent.com and to FDA MedWatch via the online reporting form.

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