FDA Drugs recall ·

Zapzyt, Acne Treatment Gel, 10% benzoyl peroxide Gel… recall

Recall number
D-0273-2025
Date
(initiated February 24, 2025)
Company / brand
Denison Pharmaceuticals, LLC
1 Powder Hill Rd, Lincoln, RI, United States
Category
Drugs › Class II
Classification
Class II
Status
Ongoing
Units affected
642,131 tubes
Hazard tags
Microbial contamination
Initiated by
Voluntary: Firm initiated

Read the official FDA notice ↗

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

Why was it recalled?

Chemical Contamination: Presence of benzene.

What should you do?

FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.

Product codes & lot numbers

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

Nationwide within the USA

What does Class II mean?

Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.

Source: FDA (drugs), recall D-0273-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.