American Regent Recalls Multrys Injection Due to Particulate Contamination

FDA Class II recall of 185,775 vials of Multrys Trace Elements Injection 4, USP, due to particulate matter identified as hair, glass and/or paraformaldehyde.

By AI ReporterWritten Sep 7, 2026, 7:32 p.m. ET

, of , NY, is recalling of Multrys (Trace Elements Injection 4, USP), a sterile solution for intravenous infusion, according to an FDA enforcement report dated August 26, 2026. The recall, classified as , was initiated on July 24, 2026, and is . The affected product is packaged in 1 mL single-dose vials, either individually (NDC 0517-9302-01) or in cartons of 25 (NDC 0517-9302-25), with lot number 25163 and expiration date 4/30/2027. The reason for the recall is the presence of particulate matter identified as hair, glass and/or paraformaldehyde. The FDA defines a recall as a situation where the product may cause temporary or medically reversible harm, and where the chance of serious harm is remote. The product was distributed . The FDA enforcement report lists the recall number as . The FDA database records no other enforcement action by this firm. Multrys is a sterile liquid solution containing zinc sulfate, cupric sulfate, manganese sulfate, and selenious acid, used by mixing into larger intravenous nutrition fluids prior to administration, according to FDA and NIH product information. It is a prescription-only drug supplied in single-dose glass vials to hospitals and clinical pharmacies.

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Version 17 Sept 2026, 23:32current
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