FDA Recall D-0284-2025

Fruit Of The Earth, Inc. · Grand Prairie, TX

Class II Ongoing 429 days on record

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

Product

CVS Health Concealing Acne Treatment Cream, CVS, 10% benzoyl peroxide, 1 oz (28 g), Distributed by: CVS Pharmacy, Inc

Lot / code: 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

Quantity: 112045 tubes

Reason for recall

Chemical contamination: presence of benzene

Recall record

Recall number: D-0284-2025
Classification: Class II
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Letter
Distribution: USA Nationwide
Recall initiated: 2025-03-11
Classified by FDA Center: 2025-03-18
FDA published: 2025-03-26
Recalling firm: Fruit Of The Earth, Inc.
Firm location: Grand Prairie, TX

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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