FDA Drug Recalls

Recalls / Class II

Class IID-0196-2026

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

Affected lot / code info
Lot D54947, exp 4/30/2028

Why it was recalled

CGMP Deviations

Recalling firm

Firm
CA BOTANA International, Inc.
Notification channel
Letter
Type
Voluntary: Firm initiated
Address
9505 Chesapeake Dr, N/A, San Diego, California 92123-1304

Distribution

Quantity
4890 bottles
Distribution pattern
CA, CO, FL, PR, WA

Timeline

Recall initiated
2025-10-10
FDA classified
2025-11-26
Posted by FDA
2025-12-03
Status
Ongoing

Source: openFDA Drug Enforcement endpoint. Recall record D-0196-2026. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.