FDA Recall D-0273-2025

Denison Pharmaceuticals, LLC · Lincoln, RI

Class II Ongoing 444 days on record

Moderate impact — Class II recall — temporary or medically reversible adverse health consequence possible; remote probability of serious adverse health consequence.

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

Lot / code: 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.

Quantity: 642,131 tubes

Reason for recall

Chemical Contamination: Presence of benzene.

Recall record

Recall number: D-0273-2025
Classification: Class II
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Letter
Distribution: Nationwide within the USA
Recall initiated: 2025-02-24
Classified by FDA Center: 2025-03-12
FDA published: 2025-03-19
Recalling firm: Denison Pharmaceuticals, LLC
Firm location: Lincoln, RI

Drug identification

Brand name(s): ZAPZYT ACNE TREATMENT GEL
Generic name(s): BENZOYL PEROXIDE
Manufacturer(s): Focus Consumer Healthcare, LLC
NDC(s): 71687-0011
Route(s): TOPICAL

Operational response

Class II recalls indicate possible temporary or reversible health consequences. Remove affected lots from active dispensing. Segregate inventory. Check the firm’s recall notification for guidance on patient outreach.

For the official FDA enforcement record, see FDA's Recall Search.

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