FDAClass IRecall started July 24, 2026

Papaverine HCl Injection 60 mg/2mL Recall: Particulate Matter

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.

What is the FDA recall status?

The FDA record lists this recall as ongoing. FDA enforcement data is not a live recall-lifecycle tracker. Follow the official instructions and check the agency notice or firm for current guidance.

How FDA enforcement data reports status

Why was Papaverine HCl Injection 60 mg/2mL recalled?

Presence of Particulate Matter: Product contaminated with particulate matter identified as glass and/or paraformaldehyde

What should I do if I have this product?

Follow the firm and FDA instructions for the affected product. Contact the recalling firm for current guidance.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare your product with the product description and available lot, UPC or model codes below from the official FDA record to check whether it is covered by this recall. If an identifier is missing or unclear, check the complete official notice or contact the firm; an incomplete match here does not establish that your product is unaffected.

Full product description

Which lot codes, UPCs or models are affected?

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

Agency record number: D-0800-2026
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.
Recalling firm: American Regent, Inc.
Quantity: 86,100 vials
Distribution: Nationwide within the U.S
Recall started: July 24, 2026
Report date: August 26, 2026
Classification: Class I
Status: Ongoing
Agency: FDA (drug)

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