Why it was recalled
CGMP Deviations
Product description
CLEARSTEM YOU ARE SUNSHINE SPF 50, Zinc Oxide 21%, 2.1 oz/61g per bottle, Distributed by: CLEARSTEM Skincare, clearstemskincare.com. NDC: 35192-046-17
Lot numbers, UPCs & expiration codes
Lot D54447, exp 11/30/2027
Where it was sold
CA, CO, FL, PR, WA
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-0195-2026
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- Oct 10, 2025
- FDA report date
- Dec 3, 2025
- Quantity
- 4890 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- CA BOTANA International, Inc.
Original FDA data
Every field from FDA enforcement report D-0195-2026, exactly as published.
Show all FDA fields
- City
- San Diego
- State
- CA
- Status
- Ongoing
- Country
- United States
- Event ID
- 97820
- Address
- 9505 Chesapeake Dr
- Code information
- Lot D54447, exp 11/30/2027
- Postal code
- 92123-1304
- Report date
- Dec 3, 2025
- Product type
- Drugs
- Recall number
- D-0195-2026
- Classification
- Class II
- Recalling firm
- CA BOTANA International, Inc.
- Product quantity
- 4890 bottles
- Reason for recall
- CGMP Deviations
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- CLEARSTEM YOU ARE SUNSHINE SPF 50, Zinc Oxide 21%, 2.1 oz/61g per bottle, Distributed by: CLEARSTEM Skincare, clearstemskincare.com. NDC: 35192-046-17
- Distribution pattern
- CA, CO, FL, PR, WA
- Recall initiation date
- Oct 10, 2025
- Initial firm notification
- Letter
- Center classification date
- Nov 26, 2025