Fresenius Kabi is voluntarily recalling one lot of Morphine Sulfate Injection USP, Simplist 2 mg/1 mL in MicroVault packaging after discovering a label mix-up that could expose patients to the wrong opioid and potentially life-threatening side effects. The recall, announced August 4, 2026, applies nationwide at the user level.
The MicroVault carton is labeled as containing Morphine Sulfate Injection 2 mg/1 mL, but may instead hold a prefilled syringe of Dilaudid (hydromorphone HCl) 0.5 mg/0.5 mL. Inadvertent administration of hydromorphone when morphine is intended carries a reasonable probability of causing serious adverse health consequences, including life‑threatening respiratory depression and death. Patients at greatest risk include those who do not regularly use opioids, individuals with underlying respiratory disease, pediatric patients, and patients taking other CNS depressants. No adverse events have been reported to date for the affected lot.
The recalled lot is Morphine Sulfate Injection USP, Simplist 2 mg/1 mL, product code 764411, lot number 6402820, with an expiration date of December 2028. The product was distributed nationwide to distributors and wholesalers between January 29 and June 9, 2026.
Fresenius Kabi is notifying distributors and customers and arranging return of the product. Health care facilities are instructed to immediately stop distributing, dispensing or using the affected lot and return all units. Distributors must notify any customers who may have received the recalled product.
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