Papaverine HCl Injection — Class I drug recall D-0800-2026
Ongoing recall by American Regent, Inc., reported 2026-08-26, distributed nationwide. Presence of Particulate Matter: Product contaminated with particulate matter identified as glass and/or parafo
| Recall number | D-0800-2026 |
|---|---|
| Product type | Drug |
| Classification | Class I |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | American Regent, Inc., Shirley, NY, United States |
| Recall initiated | 2026-07-24 |
| Classified | 2026-08-26 |
| Reported by FDA | 2026-08-26 |
| Distributed | Nationwide (US) |
| Quantity | 86,100 vials |
| Reason classes | foreign material, specification failure |
| NDC | 00517-4002, 00517-4002-01, 00517-4002-25 |
| Lot numbers | 25202 |
| Expiration dates | 2026-11-30 |
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.
Reason for recall
Presence of Particulate Matter: Product contaminated with particulate matter identified as glass and/or paraformaldehyde
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0800-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.