Tralement — Class II drug recall D-0801-2026
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-0801-2026 |
|---|---|
| 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 | 323,000 vials |
| Reason classes | foreign material, specification failure |
| NDC | 00517-9305, 00517-9305-01, 00517-9305-25 |
| Lot numbers | 25149, 25371 |
| Expiration dates | 2027-04-30, 2027-09-30 |
Product
Tralement (trace elements injection 4*, USP), packaged in a) 1mL Single Dose vials (NDC 0517-9305-01) and b) 5x1mL Single Dose vials (NDC 0517-9305-25), 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-0801-2026. 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.