Skip to content
Recall Observatory FDA recall evidence

Drug product

Zapzyt, Acne Treatment Gel, 10% benzoyl peroxide Gel, packaged in 1 oz (28.35g) tube, Distributed by: FOCUS CONSUMER HEALTHCARE, LLC., 801 Broad St Ste 200, Chattanooga, TN 37402. NDC 71687-0011-1

D-0273-2025

February 24, 2025

Class II

Product summary

Firm
Denison Pharmaceuticals, LLC
Event
Event 96384
Status
Ongoing
Classification
Class II
Quantity
642,131 tubes
Official record key
drug-enforcement:D-0273-2025

Official wording

Reason: Chemical Contamination: Presence of benzene.

Code information: Lot #: 9762, Exp. Date 2/28/2025; 9763, 9764, 9765, Exp. Date 3/31/2025; 9869, 9870, Exp. Date 5/31/2025; 9871, 9872, Exp. Date 7/31/2025; 9996, 9997, 9998, Exp. Date 8/31/2025; 9995, Exp. Date 10/31/2025; 0154, 0153, 0326, Exp. Date 1/31/2026; 0155, 0156, 0161, 0327, 0329, 0328, Exp. Date 2/28/2026; 0479, 0480, Exp. Date 5/31/2026.

Distribution pattern: Nationwide within the USA

Derived failure modes

  • Foreign material or chemical contamination

    reason.foreign_material_chemical_contamination · v1.0.0

    Chemical Contamination