FDA Recall D-0512-2025

KABANA SKIN CARE · Louisville, CO

Class II Ongoing 428 days on record

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

Product

B Natural Organics, Organic Sunscreen, Broad Spectrum, SPF 30, 25% non-nano Zinc Oxide, a) Nude Tint Mineral Formula for Face and Body, 4 oz. (120 ML) per bottle. NDC: 73369-1002-2; b) Tint Free Mineral Formula for Face and Body, 4 oz. (120 ML) per bottle. NDC: 73369-1001-2; c) Tan Tint Mineral Formula for Face and Body, 4 oz. (120 ML) per bottle. NDC: 73369-1003-2.

Lot / code: Lots: a) 410-001, Exp 10/31/2027 b) 404-003, Exp 04/30/2027 c) 404-001, Exp 04/30/2027

Quantity: 204 tubes

Reason for recall

cGMP deviations

Recall record

Recall number: D-0512-2025
Classification: Class II
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Letter
Distribution: NJ, FL, MI
Recall initiated: 2025-03-12
Classified by FDA Center: 2025-07-10
FDA published: 2025-07-16
Recalling firm: KABANA SKIN CARE
Firm location: Louisville, CO

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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