FDA recall D-0298-2025

Johnson, S C and Son, Inc · Class II · 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.

Reason for recall

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

Distribution

Nationwide in the USA

Key facts

Status: Ongoing
Initiation date: 2025-01-08
Report date: 2025-04-02
Voluntary/Mandated: Voluntary: Firm initiated
Location: Racine, WI, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0298-2025