Characteristics of product recalls of biopharmaceuticals and small-molecule drugs in the USA

• We identified 1792 recalled products during the study period; 41 recalls occurred for biopharmaceuticals and 1751 for small molecules.
• Recalls that concern the manufacturing of drug product, including stability, out of specification results and GMP issues occurred more frequently for small molecules.
• Adverse events were rarely reported in quality-related product recalls in the US.
• Injectables were considerably more likely to result in potentially dangerous when compared to other administration routes.

Compared with chemically synthesized small-molecule drugs, the manufacturing process of biopharmaceuticals is more complex. Unexpected changes to product characteristics following manufacturing changes have given rise to calls for robust systems to monitor the postauthorization safety of biopharmaceuticals. We compared quality-related product recalls in the USA of biopharmaceuticals and of small molecules. Although the reasons for recalls for biopharmaceuticals differed from those for small molecules, adverse events were rarely reported. The relative contribution of recalls that could cause serious adverse health consequences was not greater for biopharmaceuticals than for small molecules. Therefore, these data do not give rise to concerns that biopharmaceuticals are more frequently associated with unexpected safety concerns.