D-0800-2026 Class I Ongoing
FDA drug recall D-0800-2026 was initiated by American Regent, Inc. on July 24, 2026 and is designated Class I. Reason for recall: Presence of Particulate Matter: Product contaminated with particulate matter identified as glass and/or paraformaldehyde The recall status is ongoing. Affected quantity: 86,100 vials.
Recall Details
- Product Type
- Drugs
- Report Date
- August 26, 2026
- Initiation Date
- July 24, 2026
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 86,100 vials
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.
Reason for Recall
Presence of Particulate Matter: Product contaminated with particulate matter identified as glass and/or paraformaldehyde
Distribution Pattern
Nationwide within the U.S
Code Information
Lot #: 25202, Exp. Date: 11/30/2026.