American Regent recalls Papaverine HCl injection vials due to glass and paraformaldehyde contamination. This poses a risk of serious injury if injected. Consumers should contact the manufacturer for details.
Presence of Particulate Matter: Product contaminated with particulate matter identified as glass and/or paraformaldehyde
American Regent has recalled specific Papaverine HCl injection vials that contain glass or paraformaldehyde particles. Using these vials could cause serious injury if injected due to the particulate matter.
The injection vials contain glass or paraformaldehyde particles that could cause serious injury if injected. Particulate matter in injectable medications can lead to blockages, infections, or other complications.
Healthcare professionals who use this medication for medical procedures are most at risk. Patients receiving this injection under medical supervision may also be affected.
Check for vials labeled 'Papaverine HCl Injection, USP, 60 mg/2 mL (30 mg/mL)' with NDC 0517-4002-01 (single-dose) or NDC 0517-4002-25 (25-pack). These were sold by American Regent, Inc. in Shirley, NY.
Reach out to American Regent, Inc. for specific instructions on handling the recalled vials.
No, the product contains glass or paraformaldehyde particles that could cause serious injury if injected.
Check for vials labeled 'Papaverine HCl Injection, USP, 60 mg/2 mL (30 mg/mL)' with NDC 0517-4002-01 or NDC 0517-4002-25.
Contact American Regent, Inc. for specific instructions on handling the recalled vials.
We’ve drafted a message you can send American Regent to request your refund or repair — edit it as you like.
Subject: Recall D-0800-2026 — American Regent American Regent Hello, I own a American Regent that is covered by recall D-0800-2026 from American Regent. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
