Class II · Moderate risk
Zicam
CGMP Deviations; FDA inspection of the contract manufacturer noted out of limit results for microbiological testing
Hemp Bombs CBD Pain Freeze
Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.
Why it was recalled
Subpotent drug: The potency of the active (menthol) was less than the label claim of 4%.
Cause type: Wrong potency / content
Sub- or super-potent product, or a failed content-uniformity / assay test. You may receive too little or too much active ingredient - a direct dosing risk. All wrong potency / content recalls.
What was recalled
Hemp Bombs CBD Pain Freeze (menthol 4%), 400mg, 4 oz bottles, Distributed by: Global Widget 8419 Sunstate St, Tampa FL 33634; UPC code: 8-40078-56497-0
Drug: Menthol
- Recalling firm
- Global Widget LLC
- Origin
- FL, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0615-2024 · FDA notice
Low risk, still worth a check. Class III means the product is unlikely to cause harm but breaks an FDA rule (often labeling). If your lot matches, your pharmacy will normally swap it; there is no need for alarm.
Other Menthol recalls
See all
Class II · Moderate risk
Rohto Cooling Eye Drops Cool Relief
Lack of Assurance of Sterility
Class II · Moderate risk
Rohto Cooling Eye Drops Dry Aid
Lack of Assurance of Sterility
Class II · Moderate risk
Rohto Cooling Eye Drops Dry Aid
Lack of Assurance of Sterility
Class II · Moderate risk
Rohto Cooling Eye Drops Digi Eye
Lack of Assurance of Sterility
Other recalls by Global Widget LLC
All 2024 recalls
Class III · Low risk
Hemp Bombs CBD Pain Freeze
Subpotent drug: The potency of the active (menthol) was less than the label claim of 4%.
Class III · Low risk
Nature's Script CBD Cryotherapy Pain Relief Roll on
Subpotent drug: The potency of the active (menthol) was less than the label claim of 4%.
Class III · Low risk
Hemp Bombs CBD Pain Freeze
Subpotent drug: The potency of the active (menthol) was less than the label claim of 4%.
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