Papaverine HCl Injection, USP, 60 mg/2 mL (30 mg/mL), packaged in a) 2mL Single-Dose Vial (NDC 0517-4002-01), and b) 25x
Summary
The FDA issued a Class I for Papaverine HCl Injection, USP, 60 mg/2 mL (30 mg/mL), packaged in a) 2mL Single- by American Regent, Inc.. Reason: Presence of Particulate Matter: Product contaminated with particulate matter identified as glass and/or paraformaldehyde.
Details
Source
Drug Recall
External ID
D-0800-2026
Action Date
2026-08-26
Status
Ongoing
Category
drug
Product Description
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/Code Info: Lot #: 25202, Exp. Date: 11/30/2026.
Quantity Affected: 86,100 vials
Reason for Recall
Presence of Particulate Matter: Product contaminated with particulate matter identified as glass and/or paraformaldehyde
Distribution
Nationwide within the U.S
Type: Voluntary: Firm initiated
Recall Initiated: 2026-07-24
Company
Shirley, NY
Context & Analysis
This is a Class I recall. Class I recalls are the most serious — there is a reasonable probability that use of or exposure to the product will cause serious health consequences or death.
This was one of 42 drug recalls issued in the same week, part of 66 drug-related FDA actions this month.
American Regent, Inc. has 21 FDA actions in our database, including 21 recalls.
Frequently Asked Questions
What is a Class I recall?
A Class I recall is the most serious type. The FDA has determined there is a reasonable probability that the product will cause serious adverse health consequences or death. Consumers should stop using the product immediately.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (American Regent, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does American Regent, Inc. have FDA actions?
American Regent, Inc. has 21 FDA actions in our database, including 21 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0800-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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