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Class I · Most seriousActive recall

Papaverine Hydrochloride

A reasonable chance it could cause serious harm or death.

Does this affect you?
Check your lot numberLot #: 25202, Exp. Date: 11/30/2026.
Where it was soldNationwide within the U.S
Find the lot number printed on your box or bottle. If it matches — and you take this medicine — call your pharmacist. Don't stop a prescribed medicine on your own.

What happened

Presence of Particulate Matter: Product contaminated with particulate matter identified as glass and/or paraformaldehyde

What to do

  1. Check the lot number and expiry on your medicine against the recall above.
  2. Talk to your pharmacist or doctor before changing anything — don't stop on your own.
  3. Report any problems to FDA MedWatch (1-800-FDA-1088 or fda.gov/medwatch).

Who makes it

Made byAmerican Regent, Inc.
Brand namePAPAVERINE HYDROCHLORIDE
Generic namePAPAVERINE HYDROCHLORIDE
Active ingredient(s)PAPAVERINE HYDROCHLORIDE
Distributed by / forAmerican Regent, Inc.
NDC0517-4002-01
Show the full FDA record
Full product labelPapaverine HCl Injection, USP, 60 mg/2 mL (30 mg/mL), packaged in a) 2mL Single-Dose Vial (NDC 0517-4002-01), and b) 25x2mL Single-Dose Vials (NDC 0517-4002-25), Rx Only, AMERICAN REGENT, INC., SHIRLEY, NY 11967.
Recalling firmAmerican Regent, Inc.
DistributionNationwide within the U.S
Quantity86,100 vials
Recall initiated2026-07-24
Report date2026-08-26
Recall completed—
Recall numberD-0800-2026
ClassificationClass I
FDA statusOngoing
Origin on fileShirley NY United States

Related

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Source: U.S. FDA enforcement database (openFDA). Look this up on the official FDA recalls site ↗

This is public FDA recall information, not medical advice. A recall does not always mean your specific bottle is affected. Never stop a prescribed medicine without asking your pharmacist or doctor.