drugs MODERATE Updated 2026-08-26

American Regent, Inc. recalls Tralement (trace elements injection 4*, USP), packaged in a)

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Recalled 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.

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Hazard / Issue

Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehyde

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Lot #: 25149, Exp. Date: 04/30/2027; 25371, Exp. Date: 09/30/2027.

✅ What Should You Do?

  1. 1Stop taking this medication and contact your doctor or pharmacist immediately.
  2. 2Do NOT flush medications down the drain — use an FDA-approved drug take-back program.
  3. 3Check the lot number on your bottle or packaging against the recalled lots listed above.
  4. 4Report adverse events to FDA MedWatch or call 1-800-FDA-1088.
View official government recall