Doctor D. Schwab Controlling Balm Recalled for Manufacturing Deviations
Doctor D. Schwab Controlling Balm is being recalled due to manufacturing practice deviations. The recall affects 555 tubes distributed in California, Colorado, Florida, Puerto Rico, and Washington.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is a FDA Class II voluntary recall with no reported illnesses or injuries. The hazard is a manufacturing practice deviation, a procedural issue rather than a specific contamination. Per the severity rubric, voluntary precautionary recalls with no reported harm are classified as Moderate (2).
Plain-English summary
Doctor D. Schwab Controlling Balm with Tea Tree Oil and Salicyclic Acid 0.8% is being recalled due to current Good Manufacturing Practice (CGMP) deviations. The product is sold in 1 FL OZ (30 ML) tubes and identified by NDC 35192-016-05. The affected batch carries lot code D54361 with an expiration date of August 31, 2027.
The manufacturer, CA BOTANA International, Inc., initiated this voluntary recall after identifying the manufacturing practice deviations. Approximately 555 tubes of the product were distributed in California, Colorado, Florida, Puerto Rico, and Washington. No consumer illnesses or injuries have been reported in connection with this recall.
Consumers who have purchased this product may contact the manufacturer or the FDA for more information about the recall and to determine if their purchase is affected.
The recalled product
- Product
- Doctor D. Schwab Controlling Balm with Tea Tree Oil, Salicyclic Acid 0.8%, 1 FL OZ/ 30 ML per tube, Doctor D. Schwab, A division of CA BOTANA, San Diego, CA 92123. NDC: 35192-016-05
- Manufacturer
- CA BOTANA International, Inc.
- Category
- Drug — Topical Balm
- Hazard
- manufacturing-deviation
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot Code D54361
- exp 8/31/2027
Distribution
Distributed in 5 states:
- CA
- CO
- FL
- PR
- WA
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