Morphine Sulfate Injection Recalled

On Aug. 4, 2026, Fresenius Kabi initiated a nationwide voluntary recall of one lot of Morphine Sulfate Injection USP, Simplist® 2 mg/1 mL due to a labeling mix-up. MicroVaults labeled as Morphine Sulfate Injection may contain a prefilled syringe of Dilaudid® (hydromorphone HCl) Injection 0.5 mg/0.5 mL. Because hydromorphone is substantially more potent than morphine, administration of the mislabeled product has a reasonable probability of causing serious adverse health consequences, including life-threatening respiratory depression, overdose, and death. Patients at greatest risk include opioid-naïve individuals, pediatric patients, patients with underlying respiratory disease, and those receiving concomitant central nervous system depressants. As of the recall announcement, no adverse events had been reported. Morphine Sulfate Injection is FDA-approved for the management of pain that is severe enough to require an opioid analgesic when alternative treatment options are inadequate. For more information, see here.