FDA Drugs recall ·
babyganics, Sheer Blend, SPF 50 Mineral Sunscreen Fragrance Free (zinc… recall
- Recall number
- D-0298-2025
- Date
- (initiated January 8, 2025)
- Company / brand
- Johnson, S C and Son, Inc
1525 Howe St, Racine, WI, United States - Category
- Drugs › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 57,184 bottles
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
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.
Why was it recalled?
Failed stability specifications: during routine stability monitoring quality concerns were identified. Physical separation for ingredients was observed.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Lot #: a) 097C4/C080316, Exp 03/31/2026; b) 177K3/A303407, Exp 10/31/2025
Distribution
Nationwide in the USA
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (drugs), recall D-0298-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.