Quick Facts at a Glance
- Recall Date
- October 10, 2025
- Hazard Level
- HIGH
- Brands
- Doctor D. Schwab, CA-BOTANA INTERNATIONAL
- Category
- Health & Personal Care
- Sold At
- Multiple Retailers
- 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
- 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
- Doctor D. Schwab, CA-BOTANA INTERNATIONAL
- Product type
- Topical Treatment
- Model numbers
- Lot Code D54361, exp 8/31/2027
- UPC codes
- 35192-016, 35192-016-05
- Sold at
- Multiple Retailers
- 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
Doctor D. Schwab Controlling Balm is a topical treatment designed to help alleviate skin conditions with ingredients like tea tree oil and salicylic acid. Consumers typically purchase it for acne or oily skin management.
Why This Is Dangerous
CGMP deviations indicate the product may not have been manufactured according to federal quality standards. This can raise concerns regarding contamination, effectiveness, or overall safety for consumers.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
Consumers may face health risks using this product, leading to skin irritation or other complications, and may need to seek alternatives.
Practical Guidance
How to identify if yours is affected
- Check the tube for the lot code D54361.
- Verify the expiration date is 8/31/2027 or earlier.
- Recall affects product distributed in CA, CO, FL, PR, WA.
Where to find product info
The lot code and expiration date are typically printed on the back of the product tube.
What timeline to expect
Expect to receive further information on refunds or replacements within 4-6 weeks.
If the manufacturer is unresponsive
- Document all communication attempts with CA BOTANA.
- Consider reaching out through social media or customer service channels.
- File a complaint with the FDA if you do not receive a resolution.
How to prevent similar issues
- Look for CGMP compliance on new products.
- Research product reviews and brand history before purchasing.
- Consider dermatologist recommendations for skincare products.
Documentation advice
Keep a record of your purchase including receipts and any correspondence regarding the recall.
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Product Details
Brand: Doctor D. Schwab Product: Controlling Balm with Tea Tree Oil Quantity: 555 tubes NDC: 35192-016-05 Lot Code: D54361 Expiration Date: 8/31/2027 Distribution: CA, CO, FL, PR, WA
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- Lot Code D54361; Expiration 8/31/2027
- Sold in CA, CO, FL, PR, WA
- Stop using the product immediately
- Contact CA BOTANA for guidance
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