Official recall notice

FDA DrugClass INotable

Papaverine Hydrochloride Injection Recall (Jul 2026)

Product: Papaverine Hydrochloride Injection, USP 60 mg/ 2 mL; 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.

Recall date
2026-07-27
Category
Drug
FDA class
Class I

Why it was recalled

Hazard

Products were found to contain particulate matter

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Product description

Products were found to contain particulate matter

Affected products

Lot #: 25202, Exp. Date: 11/30/2026.

Verify with the official notice →
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