Class IDrug
Papaverine HCl Injection recall
Summary
American Regent, Inc. is recalling Papaverine HCl Injection (drug). According to the FDA report, the reason is: Presence of Particulate Matter: Product contaminated with particulate matter identified as glass and/or paraformaldehyde. The FDA rated this a Class I: most serious: there is a reasonable chance the product could cause serious health problems or death. Recall status: Ongoing.
Understanding this recall
What happened
American Regent is recalling Papaverine HCl Injection (60 mg/2 mL vials) because particles identified as glass and/or paraformaldehyde were found.
Why it matters
Medicines given by injection or IV go straight into the bloodstream, so they must be free of visible and sub-visible particles. Particles such as glass, metal or plastic in an injectable can, in principle, block small blood vessels or cause irritation, inflammation or clots. That risk is why the FDA treats particulate matter in injectables seriously.
Who should pay attention
Hospital, clinic and pharmacy staff who stock papaverine injection.
Distribution in the FDA report: Nationwide within the U.S
How to check your product
Check the lot number and expiration date on the vial or carton.
Codes listed by the FDA: Lot #: 25202, Exp. Date: 11/30/2026.
Based only on the FDA enforcement record plus general public-health background on this type of hazard. Not medical advice; if you have symptoms or concerns, contact a doctor or pharmacist.
Details from the FDA report
- Product
- Papaverine 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.
- Reason
- Presence of Particulate Matter: Product contaminated with particulate matter identified as glass and/or paraformaldehyde
- Lot / code info
- Lot #: 25202, Exp. Date: 11/30/2026.
- Quantity
- 86,100 vials
- Distribution
- Nationwide within the U.S
- Recalling company
- American Regent, Inc., Shirley, NY United States
- Recall started
- July 24, 2026
- FDA report date
- August 26, 2026
- Classification
- Class I: Most serious: there is a reasonable chance the product could cause serious health problems or death.
- Voluntary / mandated
- Voluntary: Firm initiated
- Status
- Ongoing
- Recall number
- D-0800-2026
What to do
- Check whether you have this product, and compare the lot numbers, codes, or dates on your package with the codes listed above.
- If it matches, stop using it and keep it away from children and pets.
- Contact the recalling company (American Regent, Inc.) or the store where you bought it about returns or refunds.
- Do not stop a prescribed medication without first talking to your pharmacist or doctor; they can help find a safe replacement.
- If you think the product made you or someone else sick, contact a doctor or pharmacist. In an emergency call 911.
- You can report problems to the FDA via MedWatch.