Study Reveals Most Common Reasons for FDA Recalls

The 5 most common reasons for Food and Drug Administration (FDA)-issued recalls were contamination, mislabeling, adverse reaction, defective product, and incorrect potency, a new study has found. Findings are published in the American Journal of Health-System Pharmacy.

Study authors conducted a retrospective analysis on all FDA-issued drug recalls over 30 months between June 20, 2012 and December 31, 2014. All prescription and non-prescription, including dietary supplements, and biological products were included for the analysis. Data regarding product type, recall firm, type of recall firm (compounding vs. non-compounding), country, voluntary or involuntary recall, method of communication of recall, recall number, FDA recall classification (class I, II, or III), product availability (prescription vs. non-prescription), reason for recall, recall initiation date, and recall report date were all analyzed.

During the 30-month study period, a total of 21,120 recalled products were identified, of which 3,045 met the inclusion criteria. The 5 firms most frequently involved comprised 299, 273, 212, 118, and 112 recalls.

A significant association was found between FDA recall classification and reasons for recall, product availability, type of recall firm, and form of communication. Researcher also pointed out that compounding facilities were more commonly linked to contamination than non-compounding facilities.

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