FDA Drugs recall ·
CLEARSTEM YOU ARE SUNSHINE SPF 50, Zinc Oxide 21%, 2.1 oz/61g per bottle… recall
- Recall number
- D-0195-2026
- Date
- (initiated October 10, 2025)
- Company / brand
- CA BOTANA International, Inc.
9505 Chesapeake Dr, San Diego, CA, United States - Category
- Drugs › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 4890 bottles
- Hazard tags
- Manufacturing practices (cGMP)
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
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
Why was it recalled?
CGMP Deviations
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 D54447, exp 11/30/2027
Distribution
CA, CO, FL, PR, WA
States: California Colorado Florida Puerto Rico Washington
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-0195-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.