HIGH

CA Botana Mineral Sunscreen Recall Covers 1,167 Tubes Over CGMP Deviations (2025)

CA Botana International recalled 1,167 tubes of Doctor. D. Schwab Mineral Sunscreen SPF 50 after CGMP deviations were found. The recall cover identifies lot D54596 with exp 1/31/2028. The distribution includes California, Colorado, Florida, Puerto Rico and Washington.

Quick Facts at a Glance

Recall Date
October 10, 2025
Hazard Level
HIGH
Brands
MINERAL SUNSCREEN, CA-Botana International
Category
Health & Personal Care
Sold At
Unknown
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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About This Product

Doctor. D. Schwab Mineral Sunscreen SPF 50 is a zinc oxide-based sunscreen sold in 4 oz tubes. It is intended to protect skin from UV radiation.

Why This Is Dangerous

CGMP deviations may affect product quality and safety. The recall notice does not specify health risks linked to use but discontinuation is advised.

Industry Context

This recall is not described as part of a broader industry pattern.

Real-World Impact

Consumers must stop using the product immediately and may face replacement or refund procedures. No injuries are reported in the notice.

Practical Guidance

How to identify if yours is affected

  1. Check NDC 35192-042-02 on the label.
  2. Look for Lot Code D54596 and Exp 01/31/2028.
  3. Confirm product is Doctor. D. Schwab Mineral Sunscreen SPF 50, 4 oz.

Where to find product info

FDA enforcement reports listing recall D-0183-2026 and CA Botana recall materials.

What timeline to expect

Refunds or replacements timelines are not specified in the notice.

If the manufacturer is unresponsive

  • Escalate to FDA or consumer protection agencies if the company is unresponsive.
  • Consider filing a consumer complaint with CPSC if applicable.

How to prevent similar issues

  • Verify CGMP compliance during manufacturing.
  • Check NDC numbers and lot codes before purchase.
  • Prefer products with clear recalls listed on FDA site.

Documentation advice

Keep recall letters, product, labels, and any correspondence with the company.

Product Details

Product: Doctor. D. Schwab Mineral Sunscreen SPF 50, Zinc Oxide 21%; 4 oz / 113.4 g per tube. Manufacturer: CA Botana International, Inc. San Diego, CA 92123. NDC: 35192-042-02. Lot: D54596. Expiration: 1/31/2028. Quantity: 1167 tubes. Distribution: CA, CO, FL, PR, WA.

Reported Incidents

No specific injuries or incidents are mentioned in the recall notice.

Key Facts

  • 1,167 tubes recalled
  • Lot D54596
  • Exp 01/31/2028
  • NDC 35192-042-02
  • Distribution: CA, CO, FL, PR, WA
  • High hazard level: CGMP deviations

Safety Guide

Not sure what to do next? Our guide walks you through the process step by step.

Read: What to Do When You Find a Recalled Product

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Safety Assessment

Risk LevelHIGH
Severity Score
8/ 10
Affected Groups
GENERAL
Injury Types
OTHER

Product Details

Model Numbers
Lot Code D54596
exp 1/31/2028
UPC Codes
35192-042
35192-042-02
Affected States
CA, CO, FL, PR, WA
Report Date
December 3, 2025
Source Agency
FDA - Drug Safety
Recall Status
ACTIVE

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