FDA Drugs recall ·
Papaverine HCl Injection, USP, 60 mg/2 mL (30 mg/mL)… recall
This is an FDA Class I recall — the most serious type.
- Recall number
- D-0800-2026
- Date
- (initiated July 24, 2026)
- Company / brand
- American Regent, Inc.
5 Ramsay Rd, Shirley, NY, United States - Category
- Drugs › Class I
- Classification
- Class I
- Status
- Ongoing
- Units affected
- 86,100 vials
- Hazard tags
- Microbial contamination
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
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.
Why was it recalled?
Presence of Particulate Matter: Product contaminated with particulate matter identified as glass and/or paraformaldehyde
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Lot #: 25202, Exp. Date: 11/30/2026.
Distribution
Nationwide within the U.S
What does Class I mean?
Class I is the most serious FDA recall class: there is a reasonable probability that using or being exposed to the product will cause serious adverse health consequences or death.
Source: FDA (drugs), recall D-0800-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.