Quick Facts at a Glance
- Recall Date
- October 10, 2025
- Hazard Level
- HIGH
- Brands
- Dr Bump Gel 4, 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
- Dr Bump Gel 4, CA Botana International
- Product type
- Topical analgesic gel
- Model numbers
- Lot D54947, exp 4/30/2028
- UPC codes
- 35192-052, 35192-052-18
- Sizes
- 4 FL OZ (118 mL)
- 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
Dr. Bump Gel Menthol 5% is a topical analgesic gel sold in 4-ounce bottles for temporary relief of minor pain. It appears under the brand Dr Bump Gel 4 and is distributed through CA Botana International and 1Beauty US LLC.
Why This Is Dangerous
Manufacturing quality deviations in CGMP practices may affect product quality and consistency. The recall does not specify a direct injury, but quality issues can pose health risks if not addressed.
Industry Context
This recall is not described as part of a broader industry pattern in the notice.
Real-World Impact
Consumers should stop using the product immediately to avoid potential quality-related harm. The recall affects thousands of bottles in several jurisdictions, but no injuries are reported yet.
Practical Guidance
How to identify if yours is affected
- Check the bottle label for Lot D54947.
- Check expiry date for 4/30/2028.
- Confirm distribution states CA, CO, FL, PR, WA.
What timeline to expect
Recall remedies and guidance are communicated by the recalling firm. No refund timeline is specified in the notice.
If the manufacturer is unresponsive
- Escalate to FDA recall helpline or consumer protection office.
- File a complaint with the FDA if your retailer is unresponsive.
- Consult a healthcare professional if you have used the product and have concerns.
How to prevent similar issues
- Check CGMP compliance indicators before purchasing topical medicines.
- Verify NDC and batch numbers on packaging.
- Keep recalls and lot-specific information for future reference.
Documentation advice
Keep the original packaging, recall notice, and any correspondence. Photograph the bottle and label for records.
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Product Details
Model numbers: Lot D54947; Expiry: 4/30/2028; Distribution states: CA, CO, FL, PR, WA; Sold since: Unknown; Price: Unknown.
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- Recalling firm: CA Botana International
- Distributor: 1Beauty US LLC, Palm Desert, CA 92211
- Units recalled: 4,890 bottles
- Lot: D54947; Exp: 4/30/2028
- Product: Dr. Bump Gel 4 Menthol 5% topical analgesic gel
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Safety Guide
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