October - December 2025 | New Safety Information or Potential Signals of Serious Risks Identified by the FDA Adverse Event Monitoring System (AEMS)

_{The drug product(s) included in any of the new safety information or potential signals of serious risks listed below may also include generic drug product(s) and biosimilar or interchangeable biosimilar biological product(s), as appropriate.}

Product Name: Trade (Active Ingredient) or Product Class	Potential Signal of a Serious Risk / New Safety Information	Additional Information (as of March 10, 2026)
Alyglo (immune globulin intravenous, human-stwk)	Increased hypersensitivity reactions in patients receiving certain product lots	FDA is evaluating the need for regulatory action.
Bispecific T-cell engager therapies Columvi (glofitamab-gxbm) injection Epkinly (epcoritamab-bysp) injection Imdelltra (tarlatamab-dlle) for injection Kimmtrak (tebentafusp-tebn) injection Talvey (talquetamab-tgvs) injection	Hypogammaglobulinemia	FDA is evaluating the need for regulatory action.
Briumvi (ublituximab-xiiy) injection Kesimpta (ofatumumab) injection Mavenclad (cladribine) tablets	Colitis	FDA is evaluating the need for regulatory action.
Calquence (acalabrutinib) capsules; tablets	Aplastic anemia	FDA is evaluating the need for regulatory action.
Datroway (datopotamab deruxtecan-dlnk) for injection	Infusion related reaction, including anaphylaxis	FDA is evaluating the need for regulatory action.
Gavreto (pralsetinib) capsules	Hepatitis B reactivation	FDA is evaluating the need for regulatory action.
Gavreto (pralsetinib) capsules	Rhabdomyolysis	FDA is evaluating the need for regulatory action.
Gavreto (pralsetinib) capsules	Tuberculosis	FDA is evaluating the need for regulatory action.
Metformin-containing products	Lactic acidosis in patients with mitochondrial disease	FDA is evaluating the need for regulatory action.
Vecuronium bromide injection (a particular generic product)	Product label confusion	The peel-off sticker on the container label was revised to include all required information, including the total quantity of drug substance per total volume and the expression of strength as 1 mg/mL concentration after reconstitution.