← FDA ENFORCEMENT
D-0298-2025Class II

Johnson, S C and Son, Inc

Recalling firm
Johnson, S C and Son, Inc
Product type
Drug
Status
Ongoing
Report date
2025-04-02
Distribution
Nationwide in the USA
Firm state
WI
Product quantity
57,184 bottles
Initiated by
Voluntary: Firm initiated
SPEQ quality domain
Validation & Qualification
Reason for recall

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

Product description

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.

Code / lot info

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

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Data: U.S. FDA openFDA enforcement API. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification.