The Recall Desk
HighFDA (Drugs)·D-0273-2025·Announced 2025-03-19

Acne treatment gel recalled for benzene contamination nationwide

Zapzyt Acne Treatment Gel (10% benzoyl peroxide) distributed nationwide is being recalled due to contamination with benzene. Consumers should stop using affected lots immediately.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: FDA Class II recall with no reported illnesses or injuries. Benzene is a serious chemical hazard, but as no harm has been reported to date, this meets the criteria for High severity (Score 3): a risk-of-harm product where injury has not yet been reported.

Plain-English summary

Denison Pharmaceuticals, LLC, in cooperation with the FDA, is recalling Zapzyt Acne Treatment Gel (10% benzoyl peroxide) in 1 oz tubes distributed nationwide. A total of 642,131 tubes have been distributed.

The recall was initiated due to the presence of benzene in affected lots. Benzene is a chemical contaminant that poses a health risk. Affected lots include: Lot #9762 (expires 2/28/2025), Lots #9763, 9764, 9765 (expire 3/31/2025), Lots #9869, 9870 (expire 5/31/2025), Lots #9871, 9872 (expire 7/31/2025), Lots #9996, 9997, 9998 (expire 8/31/2025), Lot #9995 (expires 10/31/2025), Lots #0154, 0153, 0326 (expire 1/31/2026), Lots #0155, 0156, 0161, 0327, 0329, 0328 (expire 2/28/2026), and Lots #0479, 0480 (expire 5/31/2026).

Consumers who have purchased Zapzyt Acne Treatment Gel should check the lot number on their package against the affected lots listed above. If you have an affected product, stop using it immediately and do not apply it to skin. Consumers with questions about the recall can contact the manufacturer or the FDA.

The recalled product

Product
ZAPZYT ACNE TREATMENT GEL (BENZOYL PEROXIDE)
Brand
ZAPZYT ACNE TREATMENT GEL
Manufacturer
Denison Pharmaceuticals, LLC
Category
Drug — Topical acne treatment
Hazard
  • benzene
  • chemical-contamination

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

  • 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

UPCs (1)

  • 0010768001102

Distribution

Distributed nationwide across the United States.

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