HIGH

Dr. Bump Gel Menthol 5% Recall for 4,890 Bottles Over CGMP Deviations

Dr. Bump Gel Menthol 5% recall covers 4,890 bottles distributed by 1Beauty US LLC to California, Colorado, Florida, Puerto Rico and Washington. The recall is due to CGMP deviations. Stop using the product immediately and contact CA Botana International for guidance.

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

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

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

  1. Check the bottle label for Lot D54947.
  2. Check expiry date for 4/30/2028.
  3. Verify NDC 35192-052-18 and UPC 8 18204 02513 8.
  4. Confirm distribution states CA, CO, FL, PR, WA.

Where to find product info

FDA recall page: enforce_rpt-Product-Tabs.cfm?recall_number=D-0196-2026

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.

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
  • NDC: 35192-052-18; UPC: 8 18204 02513 8
  • Lot: D54947; Exp: 4/30/2028
  • Product: Dr. Bump Gel 4 Menthol 5% topical analgesic gel

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 D54947
exp 4/30/2028
UPC Codes
35192-052
35192-052-18
Affected States
CA, CO, FL, PR, WA
Report Date
December 3, 2025
Source Agency
FDA - Drug Safety
Recall Status
ACTIVE

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