FDA Drug Recalls

Recalls / Class II

Class IID-0194-2026

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

Affected lot / code info
Lot D53681, exp 03/31/2027

Why it was recalled

CGMP Deviations

Recalling firm

Firm
CA BOTANA International, Inc.
Notification channel
Letter
Type
Voluntary: Firm initiated
Address
9505 Chesapeake Dr, N/A, San Diego, California 92123-1304

Distribution

Quantity
N/A
Distribution pattern
CA, CO, FL, PR, WA

Timeline

Recall initiated
2025-10-10
FDA classified
2025-11-26
Posted by FDA
2025-12-03
Status
Ongoing

Source: openFDA Drug Enforcement endpoint. Recall record D-0194-2026. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.

Class II recall: drug · FDA Drug Recalls