Papaverine HCl Injection, USP, 60 mg/2 mL (30 mg/mL),… was recalled on July 24, 2026 in cooperation with the U.S. Food and Drug Administration because presence of Particulate Matter: Product contaminated with particulate matter identified as glass and/or paraformaldehyde.
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.
Lot #: 25202, Exp. Date: 11/30/2026.
Units affected: 86,100 vials
Where it was sold: Nationwide within the U.S
Compare the codes above against the label on your product — usually on the bottom, the back panel, or the packaging. If your unit isn't listed, it is not part of this recall.
Presence of Particulate Matter: Product contaminated with particulate matter identified as glass and/or paraformaldehyde
Class I is the most serious FDA recall level: using or being exposed to the product could cause serious health problems or death.
Stop using the product. Return it to the place of purchase for a refund, or dispose of it. Contact the recalling firm with questions.
Contact: Recalling firm: American Regent, Inc.
Not sure what you're entitled to? Read our guide: what to do if your product is recalled.
Always confirm details on the official notice from the U.S. Food and Drug Administration before acting.
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