HIGHFDA DRUG

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.

Official notice

Source-backed recall notice

No product image was available from the source feed.

Official source
FDA DRUG
Recall date
October 10, 2025
Status
ACTIVE
Severity
8/10

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

What to Do Now

Use this page like a recall checklist: verify the product first, then act on the official remedy.

Immediate steps

  1. 1Stop using the product until you confirm whether it is included in the recall.
  2. 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
  3. 3Follow the official remedy from FDA - Drug Safety; save photos, receipts, labels, and correspondence before contacting the company.
  4. 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.

Check these identifiers

Brand
MINERAL SUNSCREEN, CA-Botana International
Product type
Mineral Sunscreen
Model numbers
Lot Code D54596, exp 1/31/2028
UPC codes
35192-042, 35192-042-02
Sizes
4 oz / 113.4 g per tube
Sold at
Unknown
Where affected
CA, CO, FL, PR, WA

Recall Timeline

Key dates and source checks for this recall record.

  1. Recall announced

    October 10, 2025

  2. Reported by FDA DRUG

    December 3, 2025

  3. RecallRadar source check

    April 18, 2026

  4. 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

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.

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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

  • 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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