Multi-event March 2025 FDA Recall Drug by Fruit Of The Earth, Inc.
This Multi-event Class II drug recall was voluntarily initiated by Fruit Of The Earth, Inc. on March 11, 2025 for the product Drug. The FDA reported the reason for recall as chemical contamination. The product was distributed Nationwide and the recall is currently ongoing.
Reported Recall Events
Recall Number: D-0283-2025
Chemical contamination: presence of benzene
03-11-2025
03-26-2025
100,970 tubes
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Fruit Of The Earth, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
USA Nationwide
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Walgreens Maximum Strength Tinted Acne Treatment Cream 10% Benzoyl Peroxide/Acne Medication, 0.65 oz (18.4g) tube in a carton; Distributed by: Walgreen CO., 200 Wilmot Rd., Deerfield, IL 60015
Batch or Lot Expiration Information
Lot# : 4970743B, 4970743C Exp 3/31/2026, 9722793A, Exp 9/30/2026; 8363513A, Exp 12/3/2026; 2822284A, Exp 8/31/2027; 2143554A, Exp 12/31/2027.
Recall Number: D-0284-2025
Chemical contamination: presence of benzene
03-11-2025
03-26-2025
112045 tubes
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Fruit Of The Earth, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
USA Nationwide
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
CVS Health Concealing Acne Treatment Cream, CVS, 10% benzoyl peroxide, 1 oz (28 g), Distributed by: CVS Pharmacy, Inc
Batch or Lot Expiration Information
Lot# : 4970743A, Exp 3/31/2026; 9712793A, Exp9/30/2026; 8363513B, Exp 12/31/2026; 1391304A, 5101574A, Exp 5/31/2027; 1292084A, 1292084B, 1292084C, Exp 7/31/2027; 2892384A, Exp 8/31/2027; 6203044A, 6203044B, Exp 10/31/2027; 2153564A, 2153564B, Exp 12/31/2027; 2163564A, Exp 1/31/2028
