FDA-Drug2026-08-26Class IIPROCESSING DEFECT
American Regent Multrys trace elements injection recalled for particulate contamination
What this means
American Regent is recalling Multrys (Trace Elements Injection 4, USP) due to contamination with particulate matter, including hair, glass, and/or paraformaldehyde. The contamination was identified in specific lot 25163 (expiration 4/30/2027). This is a prescription intravenous medication used in hospitals and clinical settings.
- If you are a healthcare provider or facility, check your inventory for lot 25163 with expiration date 4/30/2027.
- Do not use vials from this lot.
- Contact American Regent or your supplier for instructions on return or disposal.
- Report any adverse events to the FDA MedWatch program.
The agency's original wording
Hazard
Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehyde
Intended for
Adults
Illnesses reported
None reported
Sold states
Nationwide within the U.S
Affected count
185,775 vials
Manufactured in
5 Ramsay Rd, Shirley, NY, United States
Products
Multrys (Trace Elements Injection 4, USP), For intravenous infusion, packaged in a) 1 mL Single-Dose Vial (NDC 0517-9302-01), and b) 25x1 mL Single-Dose Vials (NDC 0517-9302-25) Rx Only, AMERICAN REGENT, INC., SHIRLEY, NY 11967.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0799-2026More American Regent recalls
- FDA-Drug2026-09-16American Regent epinephrine injection recalled for particulate matter and sterility concerns
- FDA-PR2026-09-03American Regent epinephrine injection recalled for particulate matter and sterility concerns
- FDA-Drug2026-08-26American Regent Cyanocobalamin injection recalled for particulate contamination
- FDA-Drug2026-08-26American Regent Tralement trace elements injection recalled for particulate contamination
- FDA-Drug2026-08-26American Regent aminocaproic acid injection recalled for particulate contamination
Want us to check the next one for you?
We read every CPSC, FDA, USDA, and NHTSA notice and email you a plain-English Sunday brief covering your household — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.