AMINAOCAPROIC ACID INJECTION — Class II drug recall D-0794-2026
Ongoing recall by American Regent, Inc., reported 2026-08-26, distributed nationwide. Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or
| Recall number | D-0794-2026 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| 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 | 63,200 vials |
| Reason classes | foreign material, specification failure |
| NDC | 00517-9120, 00517-9120-01, 00517-9120-25 |
| Lot numbers | 24299 |
| Expiration dates | 2026-08-31 |
Product
AMINAOCAPROIC ACID INJECTION, USP, 250 mg/mL (5 g/20 mL), packaged in a) 20 mL MULTIPLE DOSE VIAL FOR IV INFUSION (NDC 0517-9120-01), and b) 25x20 mL MULTIPLE DOSE VIALS (NDC 0517-9120-25), Rx Only, American Regent, Inc., Shirley, NY 11967.
Reason for recall
Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, 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-0794-2026. 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.