Cooling Menthol Extra Strength Pain Relief Patch recall
FDA recall D-0075-2025 · initiated Nov 1, 2024
JR Watkins recalled Cooling Menthol Extra Strength Pain Relief Patch in Nov 2024 — an FDA Class II recall (D-0075-2025) because cGMP Deviations.
May cause temporary or medically reversible harm; low probability of serious harm.
Why it was recalled
cGMP Deviations
The manufacturing process itself
The FDA found the process itself out of compliance, usually before any defective product was identified.
This is a manufacturing or quality failure, not a finding that the medicine is unsafe to take — across every recall we hold, none was issued for that reason. It does not mean the batch was harmless.
Is your product affected? Check the lot number
A recall covers only specific lots. Find the lot number and expiration date on your package and compare them to the affected codes below — if yours is not listed, it was not part of this recall.
Quantity recalled: 7,138 patches
Details
- Product
- 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
- Recalling company
- JR Watkins
- Classification
- Class II
- Status
- Terminated
- Type
- Voluntary: Firm initiated
- Distribution
- Nationwide in the US
- Initiated
- Nov 1, 2024
- FDA report date
- Dec 4, 2024
Frequently asked
- Was Cooling Menthol Extra Strength Pain Relief Patch recalled?
- JR Watkins recalled Cooling Menthol Extra Strength Pain Relief Patch in Nov 2024 — an FDA Class II recall (D-0075-2025) because cGMP Deviations. May cause temporary or medically reversible harm; low probability of serious harm.
- Why was Cooling Menthol Extra Strength Pain Relief Patch recalled?
- Per the FDA enforcement record, the reason for recall D-0075-2025 was: cGMP Deviations
- Is a recalled Cooling Menthol Extra Strength Pain Relief Patch dangerous to take?
- An FDA recall removes specific lots from the market for a defined reason and does not by itself mean the medicine is unsafe for everyone — your specific lot may never have been affected. May cause temporary or medically reversible harm; low probability of serious harm. Check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This reproduces public FDA data and is not medical advice.
- Which lots of Cooling Menthol Extra Strength Pain Relief Patch are affected?
- Distributed: Nationwide in the US. The recall covers these lots — Lot # JC101, JC102 and JC103, exp. date Oct 31, 2025. Check the lot number and expiration date on your package against this list; if yours is not listed, it was not part of recall D-0075-2025.