Why it was recalled
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
Lot numbers, UPCs & expiration codes
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.
Where it was sold
Nationwide within the USA
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0273-2025
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- Feb 24, 2025
- FDA report date
- Mar 19, 2025
- Quantity
- 642,131 tubes
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Denison Pharmaceuticals, LLC
Original FDA data
Every field from FDA enforcement report D-0273-2025, exactly as published.
Show all FDA fields
- City
- Lincoln
- State
- RI
- Status
- Ongoing
- Country
- United States
- Event ID
- 96384
- Address
- 1 Powder Hill Rd
- Code information
- 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.
- Postal code
- 02865-4407
- Report date
- Mar 19, 2025
- Product type
- Drugs
- Recall number
- D-0273-2025
- Classification
- Class II
- Recalling firm
- Denison Pharmaceuticals, LLC
- Product quantity
- 642,131 tubes
- Reason for recall
- Chemical Contamination: Presence of benzene.
- Voluntary / mandated
- Voluntary: Firm initiated
- 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
- Recall initiation date
- Feb 24, 2025
- Initial firm notification
- Letter
- Center classification date
- Mar 12, 2025