Denison Pharmaceuticals, LLC: Drug Recall

Recall #D-0273-2025 · 02/24/2025

Class II: Risk

Recall Details

Recall Number: D-0273-2025
Classification: Class II
Product Type: Drug
Recalling Firm: Denison Pharmaceuticals, LLC
Status: Ongoing
Date Initiated: 02/24/2025
Location: Lincoln, RI, United States
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 642,131 tubes

Reason for Recall

Chemical Contamination: Presence of benzene.

Product Description

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

Distribution Pattern

Nationwide within the USA

Other Recalls by Denison Pharmaceuticals, LLC

Class III: Low Risk 09/25/2024

Crystallization: Lack of uniformity - a change in texture, chunky, grainy, and small crystal substances inside the bottles.
Class III: Low Risk 09/25/2024

Crystallization: Lack of uniformity - a change in texture, chunky, grainy, and small crystal substances inside the bottles.
Class II: Risk 05/28/2024

cGMP deviations: Test results confirmed aypical Burkholderia Cepacia were a result of personnel error.
Class II: Risk 05/03/2023

CGMP Deviations: Use of non-food grade lubricant in mixing vessel.
Class II: Risk 05/03/2023

CGMP Deviations: Use of non-food grade lubricant in mixing vessel.

View all recalls by Denison Pharmaceuticals, LLC →

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.