American Regent, Inc. Tralement (trace elements injection 4*, USP) Recall
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 |
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.
How to identify the recalled item
| Lot / date codes | Lot #: 25149, Exp. Date: 04/30/2027; 25371, Exp. Date: 09/30/2027. |
|---|---|
| Lot / date codes | Lot #: 25082, Exp. Date: 3/31/2027. |
These are the identifiers FDA published for this recall. Most recall notices list no UPC or model number at all — if the code on your item is not shown here, that does not mean the item is excluded. Check the official notice, or contact the company.
Other American Regent, Inc. recalls
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.