FDA Recall D-0298-2025

Johnson, S C and Son, Inc · Racine, WI

Class II Ongoing 491 days on record

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

Product

babyganics, Sheer Blend, SPF 50 Mineral Sunscreen Fragrance Free (zinc oxide 20%), a) 1.7 FL OZ (50 mL) bottle, UPC 810035921658, b) 8 FL OZ (236 mL) bottle, UPC 810035921382, Dist. by KAS Direct, LLC, 1525 Howe St., Racine, WI 53403, Made in Canada.

Lot / code: Lot #: a) 097C4/C080316, Exp 03/31/2026; b) 177K3/A303407, Exp 10/31/2025

Quantity: 57,184 bottles

Reason for recall

Failed stability specifications: during routine stability monitoring quality concerns were identified. Physical separation for ingredients was observed.

Recall record

Recall number: D-0298-2025
Classification: Class II
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: E-Mail
Distribution: Nationwide in the USA
Recall initiated: 2025-01-08
Classified by FDA Center: 2025-03-25
FDA published: 2025-04-02
Recalling firm: Johnson, S C and Son, Inc
Firm location: Racine, WI

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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