FDA Warning: No Recall Conducted Despite Confirmed Benzene Impurity

Following an inspection in March 2025, the U.S. Food and Drug Administration issued a Warning Letter highlighting severe deficiencies in laboratory controls, stability testing, and quality unit oversight at a U.S. manufacturer of topical over-the-counter (OTC) drug products.

According to the Letter dated 30 October 2025 and published on 25 November 2025, the FDA found that finished products containing benzoyl peroxide were released without adequate benzene testing, despite benzene being a known carcinogenic degradant of this active ingredient. FDA testing confirmed benzene levels exceeding 20 ppm in at least one marketed lot.

Further findings included an inadequate stability program that did not ensure product quality throughout shelf life, as well as a quality unit that failed to properly oversee investigations, change control, and annual product reviews.

Particularly critical: although the FDA recommended a voluntary recall of a benzene-contaminated lot, the product was not recalled before its expiry.

FDA now requires comprehensive corrective actions, including independent assessments of the laboratory and quality systems, expanded stability and impurity testing, and a detailed CAPA program.

Further details are available in the Warning Letter sent to Owen Biosciences, Inc., published on the FDA website.