FDA Recall D-0302-2025

Consumer Product Partners, LLC · Smyrna, TN

Class II Ongoing 433 days on record

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

Product

[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: Lot 0643188, exp. date 10/22/2026

Quantity: 25,932 bottles

Reason for recall

Labeling; Label Mixup; some bottles have an incorrect back label indicating 91% Isopropyl Alcohol

Recall record

Recall number: D-0302-2025
Classification: Class II
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Letter
Distribution: VA
Recall initiated: 2025-03-07
Classified by FDA Center: 2025-03-27
FDA published: 2025-04-02
Recalling firm: Consumer Product Partners, LLC
Firm location: Smyrna, TN

Drug identification

Brand name(s): HYDROGEN PEROXIDE
Generic name(s): HYDROGEN PEROXIDE
Manufacturer(s): Vi-Jon, LLC
NDC(s): 0869-0871
Route(s): TOPICAL

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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