Papaverine HCl Injection recall (American Regent, Inc.)
DrugClass IOngoing
Summary: American Regent, Inc. is recalling 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.
What is being recalled
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.
Why
Presence of Particulate Matter: Product contaminated with particulate matter identified as glass and/or paraformaldehyde
How serious is it
Class I is the most serious level: FDA considers there is a reasonable probability that using or being exposed to this product will cause serious health problems or death.
Where it was sold
Nationwide within the U.S
How to tell if yours is affected
Lot #: 25202, Exp. Date: 11/30/2026.
What to do
Check the product name, lot number and expiration date on your package against the codes above. If they match, do not stop taking a prescription medicine without talking to your doctor or pharmacist first; ask them about a replacement. Return or dispose of the product as your pharmacy advises.
Recall facts
| Recall number | D-0800-2026 |
| Category | Drug |
| Agency | U.S. Food and Drug Administration (FDA) |
| Severity | Class I |
| Status | Ongoing |
| Recall started | July 24, 2026 |
| Reported | August 26, 2026 |
| Company | American Regent, Inc. |
| Company location | Shirley, NY, United States |
| Initiated by | Voluntary: Firm initiated |
| Quantity | 86,100 vials |
More recalls from American Regent, Inc. · all drug recalls · recalls from July 2026