Class II · Moderate risk
Zicam
CGMP Deviations; FDA inspection of the contract manufacturer noted out of limit results for microbiological testing
Cooling Menthol Extra Strength Pain Relief Patch
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
cGMP Deviations
Cause type: cGMP deviation
Departures from current Good Manufacturing Practice found in production or during FDA inspection. A broad quality-system cause: the batch was made under conditions that fall short of FDA manufacturing standards. All cgmp deviation recalls.
What was recalled
Cooling Menthol Extra Strength Pain Relief Patch, Menthol 7.5%, packaged in box of 5, Distributed by J.R. Watkins LLC, Oakland CA 94612 UPC 8 56294 00878 5, NDC 72342-100-05
Affected NDC
72342-0100-05
Compare with the code on your package — it is the most precise check available.
Drug: Menthol
- Recalling firm
- JR Watkins
- NDC code
- 72342-100-05
- Origin
- PA, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0075-2025 · FDA notice
Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
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 cgmp deviation recalls from 2024
All cgmp deviation recalls
Class II · Moderate risk
First Aid Beauty Ultra Repair Cream
CGMP Deviations; product intended for quarantine was inadvertently distributed
Class II · Moderate risk
medroxyPROGESTERone Acetate Injectable Suspension
CGMP Deviations
Class II · Moderate risk
10 Irregular Pigmentation
CGMP Deviations: Inconsistency in the water systems.
Class II · Moderate risk
Henry Schein
CGMP deviations: the bulk product was rejected by the Quality Unit after routine inspection of the mixing vessel showed scratches on the sides and bottom of the mixing vessel. Product was to be rejected but was inadvertently released and shipped to customers.
Free recall alerts
Know the day your medication is recalled
Tell us what you take. When FDA posts a recall announcement or classifies a recall for one of your medications, we email you in plain English, with what to check. No account needed.