FDA Recall D-0194-2026
CA BOTANA International, Inc. · San Diego, CA
Class II Ongoing 216 days on record
Moderate impact — Class II recall — temporary or medically reversible adverse health consequence possible; remote probability of serious adverse health consequence.
Product
Elixir by Coco March Tinted Mineral Sunscreen SPF 50, Zinc Oxide 21%, 2.1 oz (62g) per bottle, Distributed by: VitaTienda Co U.S.A., San Juan, PR 00646. NDC: 35192-050-17, UPC 6 7229 99913 8
Reason for recall
CGMP Deviations
Recall record
- Recall number
D-0194-2026- Classification
- Class II
- Status
- Ongoing
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Letter
- Distribution
- CA, CO, FL, PR, WA
- Recall initiated
- 2025-10-10
- Classified by FDA Center
- 2025-11-26
- FDA published
- 2025-12-03
- Recalling firm
- CA BOTANA International, Inc.
- Firm location
- San Diego, CA
Operational response
Class II recalls indicate possible temporary or reversible health consequences. Remove affected lots from active dispensing. Segregate inventory. Check the firm’s recall notification for guidance on patient outreach.
For the official FDA enforcement record, see FDA's Recall Search.