Why it was recalled
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.
Lot numbers, UPCs & expiration codes
Lot #: a) 097C4/C080316, Exp 03/31/2026; b) 177K3/A303407, Exp 10/31/2025
Where it was sold
Nationwide in the USA
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0298-2025
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- Jan 8, 2025
- FDA report date
- Apr 2, 2025
- Quantity
- 57,184 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Johnson, S C and Son, Inc
Original FDA data
Every field from FDA enforcement report D-0298-2025, exactly as published.
Show all FDA fields
- City
- Racine
- State
- WI
- Status
- Ongoing
- Country
- United States
- Event ID
- 96334
- Address
- 1525 Howe St
- Code information
- Lot #: a) 097C4/C080316, Exp 03/31/2026; b) 177K3/A303407, Exp 10/31/2025
- Postal code
- 53403-2237
- Report date
- Apr 2, 2025
- Product type
- Drugs
- Recall number
- D-0298-2025
- Classification
- Class II
- Recalling firm
- Johnson, S C and Son, Inc
- Product quantity
- 57,184 bottles
- Reason for recall
- Failed stability specifications: during routine stability monitoring quality concerns were identified. Physical separation for ingredients was observed.
- Voluntary / mandated
- Voluntary: Firm initiated
- 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.
- Distribution pattern
- Nationwide in the USA
- Recall initiation date
- Jan 8, 2025
- Initial firm notification
- Center classification date
- Mar 25, 2025