Dr. Bump Natural Pain Relief Gel Recalled for Manufacturing Deviations
Dr. Bump Natural Pain Relief Gel (Lot D54947) is being recalled due to manufacturing quality deviations. The Class II recall affects 4,890 bottles distributed in CA, CO, FL, PR, and WA.
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 an FDA Class II recall initiated voluntarily by the firm as a precautionary measure due to CGMP deviations. No illnesses or injuries have been reported. The rubric explicitly classifies voluntary precautionary recalls as Moderate (Score 2).
Plain-English summary
Dr. Bump Natural Pain Relief Gel, Menthol 5% (4 FL OZ bottles), is being recalled by CA BOTANA International, Inc. (distributed by 1Beauty US LLC, Palm Desert, CA). The product is NDC 35192-052-18, Lot D54947 with expiration date 4/30/2028.
The FDA classified this as a Class II recall due to Current Good Manufacturing Practice (CGMP) deviations identified during manufacturing. No illnesses or injuries have been reported.
Approximately 4,890 bottles were distributed in California, Colorado, Florida, Puerto Rico, and Washington. The recall was initiated by the firm on October 10, 2025, and remains ongoing.
Consumers who have purchased this product should discontinue use and contact the manufacturer or distributor for return or disposal instructions.
The recalled product
- Product
- Dr. Bump Natural Pain Relief Gel, Menthol 5%, NET WT 4 FL OZ/118 ML per bottle, Distr. by 1Beauty US LLC, Palm Desert, CA 92211. NDC: 35192-052-18, UPC 8 18204 02513 8
- Manufacturer
- CA BOTANA International, Inc.
- Category
- Drug — Topical Analgesic
- Hazard
- cgmp-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 D54947
- exp 4/30/2028
Distribution
Distributed in 5 states:
- CA
- CO
- FL
- PR
- WA
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