HIGH

555 Doctor D. Schwab Controlling Balm Tubes Recalled Over CGMP Violations

Doctor D. Schwab recalled 555 tubes of Controlling Balm with Tea Tree Oil after identifying CGMP deviations. The product may not meet quality standards, posing a safety risk. Consumers should stop using the balm immediately and contact CA BOTANA for guidance.

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

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 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

  1. Check the tube for the lot code D54361.
  2. Verify the expiration date is 8/31/2027 or earlier.
  3. 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.

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

  • 555 tubes recalled
  • Lot Code D54361; Expiration 8/31/2027
  • Sold in CA, CO, FL, PR, WA
  • Stop using the product immediately
  • Contact CA BOTANA for guidance

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
7/ 10
Affected Groups
GENERAL
Injury Types
OTHER

Product Classification

Product Details

Model Numbers
Lot Code D54361
exp 8/31/2027
UPC Codes
35192-016
35192-016-05
Affected States
CA, CO, FL, PR, WA
Report Date
December 3, 2025
Source Agency
FDA - Drug Safety
Recall Status
ACTIVE

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