Menthol pain relief patches recalled for manufacturing practice violations
J.R. Watkins is recalling Cooling Menthol Extra Strength Pain Relief Patches nationwide due to manufacturing practice deviations. The recall affects approximately 7,138 patches from lots JC101, JC102, and JC103.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is a Class II recall with no reported illnesses or injuries. The reason for recall is manufacturing practice deviations rather than a specific health hazard. Per the rubric, this qualifies as a voluntary precautionary recall (Moderate severity).
Plain-English summary
J.R. Watkins LLC is recalling Cooling Menthol Extra Strength Pain Relief Patches containing 7.5% menthol, packaged in boxes of five. The recall involves approximately 7,138 patches with lot numbers JC101, JC102, and JC103, bearing an expiration date of October 31, 2025. These patches were distributed nationwide throughout the United States.
The recall was initiated due to deviations from FDA Good Manufacturing Practice (cGMP) standards. The company voluntarily initiated this recall, with the FDA formally classifying it as a Class II recall on November 27, 2024.
Consumers who have obtained these patches should discontinue use. The recall was initiated on November 1, 2024, and terminated on September 16, 2025.
The recalled product
- 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
- Manufacturer
- JR Watkins
- Category
- Drug — Topical Pain Relief
- Hazard
- Affected units
- 7,138
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (4)
- Lot # JC101
- JC102 and JC103
- exp. date Oct 31
- 2025
Distribution
Distributed nationwide across the United States.
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