American Regent, Inc. Tralement (trace elements injection 4*, USP) Recall
Announced 2026-08-26 · FDA
The FDA recalls American Regent, Inc.'s Tralement trace elements injection 4*, USP due to contamination with particulate matter identified as hair, glass and/or paraformaldehyde. About 323,000 vials across two lots (Lot 25149 with exp. 04/30/2027 and Lot 25371 with exp. 09/30/2027) were distributed nationwide; the recall is described as moderate severity. No corrective action details are provided in the available information.
| Brand | American Regent, Inc. |
|---|---|
| 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 | Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehyde |
| Severity | moderate |
| Units affected | 26450 |
| Distribution | Nationwide within the U.S |
| Agency | FDA |
| Recall / campaign no. | Lot #: 25149, Exp. Date: 04/30/2027; 25371, Exp. Date: 09/30/2027. |
WHAT YOU SHOULD DO
- Do not use any Tralement vials from Lot 25149 or Lot 25371.
- Contact your healthcare provider or supplier for instructions on return or disposal of affected product.
- Check your supply for the listed lot numbers and expiration dates to confirm if affected.
- If you have experienced an adverse reaction, contact your clinician and report it to FDA MedWatch.
This is an automatically maintained record of an official recall notice. Details can change; always follow the official notice linked above. See all records in the Recall Database.