[CORRECT FRONT PANEL] Hydrogen Peroxide Topical Solution, USP, 32 FL OZ (1 QT) 946 mL per bottle, NDC 0869-0871-45; [INC
Summary
The FDA issued a Class II for [CORRECT FRONT PANEL] Hydrogen Peroxide Topical Solution, USP, 32 FL OZ (1 QT) 9 by Consumer Product Partners, LLC. Reason: Labeling; Label Mixup; some bottles have an incorrect back label indicating 91% Isopropyl Alcohol.
Details
Source
Drug Recall
External ID
D-0302-2025
Action Date
2025-04-02
Status
Ongoing
Category
drug
Product Description
[CORRECT FRONT PANEL] Hydrogen Peroxide Topical Solution, USP, 32 FL OZ (1 QT) 946 mL per bottle, NDC 0869-0871-45; [INCORRECT BACK LABEL] Isopropyl alcohol 91%, Dist. by: Amazon.com Services, LLC, Seattle, WA 98109.
Lot/Code Info: Lot 0643188, exp. date 10/22/2026
Quantity Affected: 25,932 bottles
Reason for Recall
Labeling; Label Mixup; some bottles have an incorrect back label indicating 91% Isopropyl Alcohol
Distribution
VA
Type: Voluntary: Firm initiated
Recall Initiated: 2025-03-07
Company
Smyrna, TN
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 81 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
Consumer Product Partners, LLC has 5 FDA actions in our database, including 5 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 (Consumer Product Partners, LLC) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Consumer Product Partners, LLC have FDA actions?
Consumer Product Partners, LLC has 5 FDA actions in our database, including 5 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0302-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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