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Recall Observatory FDA recall evidence

Drug 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.

D-0298-2025

January 08, 2025

Class II

Product summary

Firm
Johnson, S C and Son, Inc
Event
Event 96334
Status
Ongoing
Classification
Class II
Quantity
57,184 bottles
Official record key
drug-enforcement:D-0298-2025

Official wording

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

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

Distribution pattern: Nationwide in the USA

Derived failure modes

  • Potency or specification failure

    reason.potency_specification_failure · v1.0.0

    Failed stability specifications