D-0799-2026 Class II Ongoing

Recalled by American Regent, Inc. — Shirley, NY

FDA drug recall D-0799-2026 was initiated by American Regent, Inc. on July 24, 2026 and is designated Class II. Reason for recall: Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehyde The recall status is ongoing. Affected quantity: 185,775 vials.

Recall Details

Product Type
Drugs
Report Date
August 26, 2026
Initiation Date
July 24, 2026
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
185,775 vials

Product Description

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.

Reason for Recall

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

Distribution Pattern

Nationwide within the U.S

Code Information

Lot #: 25163, Exp. Date: 4/30/2027.