CVS Health Concealing Acne Treatment Cream, CVS, 10% benzoyl peroxide, 1 oz (28 g), Distributed by: CVS Pharmacy, Inc
Summary
The FDA issued a Class II for CVS Health Concealing Acne Treatment Cream, CVS, 10% benzoyl peroxide, 1 oz (28 by Fruit Of The Earth, Inc.. Reason: Chemical contamination: presence of benzene.
Details
Source
Drug Recall
External ID
D-0284-2025
Action Date
2025-03-26
Status
Ongoing
Category
drug
Product Description
CVS Health Concealing Acne Treatment Cream, CVS, 10% benzoyl peroxide, 1 oz (28 g), Distributed by: CVS Pharmacy, Inc
Lot/Code Info: 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 Affected: 112045 tubes
Reason for Recall
Chemical contamination: presence of benzene
Distribution
USA Nationwide
Type: Voluntary: Firm initiated
Recall Initiated: 2025-03-11
Company
Grand Prairie, TX
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 60 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
Fruit Of The Earth, Inc. has 2 FDA actions in our database, including 2 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Fruit Of The Earth, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Fruit Of The Earth, Inc. have FDA actions?
Fruit Of The Earth, Inc. has 2 FDA actions in our database, including 2 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0284-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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