Topical menthol back patch recalled for manufacturing deviations
ABSORBINE jr. Extra Large Back Patch containing 5% menthol is being recalled nationwide due to manufacturing compliance deviations. The Class II recall affects 6,848,820 patches distributed by Absorbine Jr., LLC.
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 an FDA Class II recall for manufacturing process deviations with no reported illnesses or injuries. The recall was voluntary and precautionary in nature. Voluntary precautionary recalls without reported health effects align with Moderate severity per the rubric.
Plain-English summary
ABSORBINE jr. Extra Large Back Patch is a topical menthol patch containing 5% menthol, manufactured by Unexo Life Sciences Private Limited and distributed by Absorbine Jr., LLC. The recalled product consists of 6,848,820 patches with UPC codes 8 89476 41218 6 and 8 89476 41236 0.
The FDA issued a Class II recall on December 4, 2024, for cGMP deviations at the manufacturing facility. The manufacturer voluntarily initiated the recall on October 24, 2024, and the recall was terminated on September 16, 2025.
The recalled patches were distributed nationwide in the United States. Consumers who have this product should discontinue use.
The recalled product
- Product
- ABSORBINE jr. Extra Large BACK PATCH, Menthol 5%, 1 extra large patch per box, Distributed By: Absorbine Jr., LLC, Chattanooga, TN 37402 UPC 8 89476 41218 6, UPC 8 89476 41236 0
- Manufacturer
- Unexo Life Sciences Private Limited
- Category
- Drug — Topical patch
- Hazard
- Affected units
- 6,848,820
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 (2)
- UPC 8 89476 41218 6
- UPC 8 89476 41236 0
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 11 recalled by Unexo Life Sciences Private Limited under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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