HIGH

Elixir by Coco March Sunscreen Recalled Over CGMP Violations

VitaTienda Co U.S.A. recalled 3,295 bottles of Elixir by Coco March Mineral Sunscreen SPF 50 on October 10, 2025. The recall stems from CGMP deviations that could affect product safety. Consumers should stop using the sunscreen immediately and contact their healthcare provider for guidance.

Quick Facts at a Glance

Recall Date
October 10, 2025
Hazard Level
HIGH
Brands
SUNSCREEN, CA-Botana International
Category
Health & Personal Care
Sold At
Multiple Retailers
Geographic Scope
5 states
At-Risk Groups
GENERAL

Hazard Information

CGMP Deviations

What You Should Do

Consumers and healthcare providers should stop using this product immediately. Contact CA BOTANA International, Inc. or your healthcare provider for guidance. Notification method: Letter

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Product Details

The recalled product is Elixir by Coco March Mineral Sunscreen SPF 50, containing 21% Zinc Oxide. It comes in 2.1 oz (62g) bottles with lot number D53682 and an expiration date of March 31, 2027. The sunscreen was distributed in California, Colorado, Florida, Puerto Rico, and Washington.

The Hazard

The recall was initiated due to CGMP deviations, which indicate that the product may not meet the required safety and quality standards. CGMP stands for Current Good Manufacturing Practice, and deviations can potentially lead to unsafe products reaching consumers.

Reported Incidents

No specific incidents or injuries related to this product have been reported at this time. However, the nature of the CGMP deviations suggests potential risks.

What to Do

Stop using the Elixir by Coco March Mineral Sunscreen immediately. Contact CA BOTANA International, Inc. or your healthcare provider for further guidance. Notification will be sent to consumers via letter.

Contact Information

For more information, consumers can visit the FDA recall page at https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?recall_number=D-0193-2026.

Key Facts

  • Recalled product: Elixir by Coco March Mineral Sunscreen SPF 50
  • Recall date: October 10, 2025
  • Quantity: 3,295 bottles
  • Distributed in CA, CO, FL, PR, WA
  • Stop using the product immediately

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Safety Assessment

Risk LevelHIGH
Severity Score
7/ 10
Affected Groups
GENERAL
Injury Types
OTHER

Product Classification

Product Details

Model Numbers
Lot D53682
exp 3/31/2027
UPC Codes
35192-048
35192-048-17
Affected States
CA, CO, FL, PR, WA
Report Date
December 3, 2025
Source Agency
FDA - Drug Safety
Recall Status
ACTIVE

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