Quick Facts at a Glance
- Recall Date
- October 10, 2025
- Hazard Level
- HIGH
- Brands
- Elixir, CA Botana International, VitaTienda Co USA
- Category
- Health & Personal Care
- Sold At
- Unknown
- Geographic Scope
- 5 states
- At-Risk Groups
- GENERAL, PREGNANT
What to Do Now
Use this page like a recall checklist: verify the product first, then act on the official remedy.
Immediate steps
- 1Stop using the product until you confirm whether it is included in the recall.
- 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
- 3Follow the official remedy from FDA - Drug Safety; save photos, receipts, labels, and correspondence before contacting the company.
- 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.
Check these identifiers
- Brand
- Elixir, CA Botana International, VitaTienda Co USA
- Product type
- Sunscreen
- Model numbers
- Lot D53682, exp 3/31/2027
- UPC codes
- 35192-048, 35192-048-17
- Sizes
- 2.1 oz (62 g) per bottle
- Sold at
- Unknown
- Where affected
- CA, CO, FL, PR, WA
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
October 10, 2025
Reported by FDA DRUG
December 3, 2025
RecallRadar source check
April 18, 2026
Consumer action
Use the official remedy and keep documentation.
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
About This Product
Mineral-based sunscreen marketed as SPF 50 with 21% zinc oxide. Intended for skin protection in sun exposure. Sold through VitaTienda distribution in multiple states.
Why This Is Dangerous
CGMP deviations indicate manufacturing quality-control issues that could affect product safety and efficacy.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
Consumers face potential safety concerns due to manufacturing deviations; immediate cessation is advised to avoid uncertain quality.
Practical Guidance
How to identify if yours is affected
- Check NDC 35192-048-17 and UPC 8 10145 82007 0 on the label.
- Look for Lot D53682 and EXP 3/31/2027 on the bottle.
- Verify distributor VitaTienda Co USA and CA Botana International contact info.
Where to find product info
FDA recall page linked in the notice and the recall letter from CA Botana International.
What timeline to expect
Refunds or replacements typically processed within 4-8 weeks after claim submission.
If the manufacturer is unresponsive
- Escalate to FDA recall office
- File a consumer complaint with CPSC if necessary
- Consult healthcare provider for guidance on safety
How to prevent similar issues
- Purchase from reputable retailers with return policies
- Check CGMP status and sunscreen ingredient safety
- Watch for recall updates on FDA site
Documentation advice
Keep recall notice, photos of product, lot number, UPC, receipts, and correspondence with the manufacturer
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Product Details
Product: Elixir by Coco March Mineral Sunscreen SPF 50. Size: 2.1 oz (62 g) per bottle. NDC: 35192-048-17. UPC: 8 10145 82007 0. Lot: D53682. Expiration: 3/31/2027. Quantity: 3295 bottles. Distributor: VitaTienda Co U.S.A., San Juan, PR 00646. Sold in: CA, CO, FL, PR, WA. Status: ACTIVE recall. Recall date: 2025-10-10.
Reported Incidents
No injuries or incidents have been reported in the recall notice.
Key Facts
- States affected: CA, CO, FL, PR, WA
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Safety Guide
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