CLEARSTEM YOU ARE SUNSHINE SPF 50 — Class II drug recall D-0195-2026
Ongoing recall by CA BOTANA International, Inc., reported 2025-12-03, distributed in CA, CO, FL, PR, WA. CGMP Deviations
| Recall number | D-0195-2026 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | CA BOTANA International, Inc., San Diego, CA, United States |
| Recall initiated | 2025-10-10 |
| Classified | 2025-11-26 |
| Reported by FDA | 2025-12-03 |
| Distributed | CA, CO, FL, PR, WA |
| Quantity | 4,890 bottles |
| Reason classes | cgmp |
| NDC | 35192-0046-17 |
| Lot numbers | D54447 |
| Expiration dates | 2027-11-30 |
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
Reason for recall
CGMP Deviations
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0195-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.