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Drug FDA Class II Terminated cGMP deviation

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

JR Watkins Published Dec 4, 2024

Risk level

Class II

May cause a temporary or reversible health problem; slight chance of serious harm.

Severity score 55/100

What should you do?

  • Check whether you have this product, using the lot codes, UPCs, and dates listed below.
  • Do not eat, serve, or sell the affected product.
  • Return it to the place of purchase for a refund, or throw it away in a sealed bag so people and animals can’t get to it.
  • Contact JR Watkins or your place of purchase with questions, and see the source record below for full details.
Reason for recall

cGMP Deviations

Affected products (1)

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

7,138 patches

Lot codes: JC101
Code info: Lot # JC101, JC102 and JC103, exp. date Oct 31, 2025

Affected areas

Nationwide

Timeline

  1. Initiated
    Nov 1, 2024
  2. Published
    Dec 4, 2024
  3. Terminated
    Sep 16, 2025
Recall number
D-0075-2025
Agency
U.S. Food and Drug Administration
Country
US
Source data (openFDA JSON) About FDA enforcement reports

FDA records come from the openFDA drug enforcement-report dataset — the agency's full weekly enforcement list. Most entries are not issued as consumer press releases, so they won't appear on fda.gov/recalls or in a web search. The source record link above resolves this exact recall by its number.