Drug Enforcement D-0273-2025

Chemical Contamination: Presence of benzene.

Status

Ongoing

Classification

Class II

Report Date

March 19, 2025

Termination Date

Product Information

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
Product quantity
642,131 tubes
Reason for recall
Chemical Contamination: Presence of benzene.
Recall initiation reason
Initial firm notification
Letter
Distribution pattern
Nationwide within the USA

Location & Firm

Recalling firm
Denison Pharmaceuticals, LLC
Address
1 Powder Hill Rd

United States
Voluntary / Mandated
Voluntary: Firm initiated
Status date

Codes & Dates

Recall number
D-0273-2025
Event ID
96384
Recall initiation date
February 24, 2025
Center classification date
March 12, 2025
Code info
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.
More code info