Recalls / Class II
Class IID-0273-2025
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
- Brand name
- Zapzyt Acne Treatment Gel
- Generic name
- Benzoyl Peroxide
- Active ingredient
- Benzoyl Peroxide
- Route
- Topical
- NDC
- 71687-0011
- FDA application
- M006
- Affected lot / 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.
Why it was recalled
Chemical Contamination: Presence of benzene.
Recalling firm
- Firm
- Denison Pharmaceuticals, LLC
- Manufacturer
- Focus Consumer Healthcare, LLC
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 1 Powder Hill Rd, Lincoln, Rhode Island 02865-4407
Distribution
- Quantity
- 642,131 tubes
- Distribution pattern
- Nationwide within the USA
Timeline
- Recall initiated
- 2025-02-24
- FDA classified
- 2025-03-12
- Posted by FDA
- 2025-03-19
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0273-2025. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.