Fresenius Kabi issued a nationwide voluntary recall of Morphine Sulfate Injection USP after discovering a labeling mix-up on the injectable opioid product, creating what the FDA identified as a significant risk of life-threatening dosing errors in hospitals, on Aug. 5.
The recall affects the company’s Simplist brand of morphine injection and applies to hospitals, pharmacies, and clinical facilities that have received the product nationwide, according to the FDA.
A label error on an injectable opioid medication poses acute patient safety risks because morphine dosing must be precise. Incorrect dosing of morphine can cause respiratory depression, overdose, or death, making labeling accuracy critical for the injectable formulation used in clinical settings.
The FDA classified the labeling error as a significant patient safety risk requiring immediate corrective action and product removal from healthcare facilities, the agency said. Hospitals and pharmacies are directed to check inventory and quarantine or return affected products.
Morphine sulfate injection is one of the most widely used medications for severe acute pain management in American hospitals. It is routinely administered in emergency departments, surgical suites, intensive care units, and palliative care settings.
Fresenius Kabi is coordinating the recall with the FDA and has notified distributors and healthcare customers, according to the recall notice. The company did not immediately disclose the specific nature of the labeling error or the volume of product affected.
Healthcare facilities are advised to implement alternative morphine supply arrangements while the recalled product is removed from circulation.