Hospira Inc. voluntarily recalled 73 lots of Propofol and 85 lots of Liposyn that were distributed between July 2009 and October 2009. The Food and Drug Administration (FDA) issued a warning letter, stating that the products, which are sold to hospitals and doctors, had been contaminated by particulates during the manufacturing process. The source of the particulate matter has been identified as stainless steel equipment used in the manufacturing process. Since these particulate contaminants do not dissolve in blood they could impede blood flow or cause mechanical damage to the body. Restriction in blood supply to tissues could lead to stroke, respiratory failure, kidney failure, or heart attack.

Propofol is a drug that reduces anxiety, and assists in achieving loss of consciousness or sleep. It is most commonly used in surgical procedures or short diagnostic tests, to induce or maintain anesthesia or in mechanically ventilated adults, as a sedative. Propofol is for injection into a vein, and must only be administered by a licensed anesthesia professional.

Also an I.V. administered drug, Liposyn is a fat emulsifier. This drug provides a patient with the a source of calories and the essential fatty acids normally obtained from a complete oral diet. According to the FDA, deaths in preterm infants after infusion of intravenous fat emulsions have been reported in the medical literature. Autopsy findings included intravascular fat accumulation in the lungs. Treatment of premature and low birth weight infants with intravenous fat emulsion must be based upon careful benefit-risk assessment.

Based in Illinois, Hospira Inc recalled Propofol and Liposyn in October because of an equipment failure at a manufacturing facility in Clayton, North Carolina. The FDA inspected the Clayton plant in January and February and also started reviewing the company's Rocky Mount, North Carolina, plant in January, where they found a failure to validate processes used in manufacturing. According to Hospira, a comprehensive review of its manufacturing operations to ensure compliance with applicable regulations is being conducted.