Millions of OTC Pain Relief Patches Recalled

Deviations from Current Good Manufacturing Practice (CGMP) regulations have prompted Unexo Life Sciences Private Limited to recall millions of over-the-counter pain relief patches sold by various distributors throughout the United States. The recalls are included in the December 4, 2024, US Food and Drug Administration (FDA) Enforcement Report, which provides no specific details on the CGMP deficiencies.

The recall affects the following products:

• Absorbine Jr Extra Large Back Patch, menthol 5%, 1 extra-large patch per box (UPC 8 89476 41218 6, UPC 8 89476 41236 0), distributed by Absorbine Jr, Chattanooga, Tennessee;
• Absorbine Jr Ultra Strength Pain Patch, menthol 6.5%, 1 patch per box (UPC 8 89476 41318 3, UPC 8 89476 41336 7), distributed by Absorbine Jr;
• Absorbine Jr Pain Relieving Knee Patch, camphor 7%, menthol 7%, 1 patch per box (UPC 8 89476 41251 3) and 6 patches per box (UPC 8 89476 41306 0), distributed by Absorbine Jr;
• TheraCare Maximum Strength Pain Relief 4% Lidocaine Patch, 1 patch per box (NDC 71101-001-24, UPC 8 45717 00878 5) and 6 patches per box (NDC 71101-001-06, UPC 8 45717 01056 6), manufactured for Veridian Healthcare, Gurnee, Illinois;
• TheraCare Cold Hot Medicated Patch, menthol 5%, 5 patches per box (NDC 71101-954-05, UPC 8 45717 00818 1), manufactured for Veridian Healthcare;
• HealthWise Period Patch Menstrual Pain Relief, menthol 10%, 10 patches per box (NDC 71101-947-10, UPC 8 45717 01072 6), manufactured for Veridian Healthcare; 
• Equate Maximum Strength Lidocaine Pain Relieving Patch, lidocaine 4% topical anesthetic, 6 patches per box (NDC 79903-106-06, UPC 6 81131 07127 7), distributed by Walmart Inc, Bentonville, Arkansas;
• LILAS Feminine Pain Relief Patch, menthol 10%, 5 patches per box (UPC 7 87099 48212 1) and 10 patches per box (UPC 7 87099 48211 4), distributed by LILAS Wellness Inc., Beaverton, Oregon;
• JR Watkins Cooling Pain Relief Patches, menthol 7.5%, 5 patches per box (UPC 8 56294 00878 5), distributed by JR Watkins, Oakland, California;
• Cheeky Bonsai Pain Relief Patches, menthol 10%, 4 patches per box (UPC 8 60006 57564 9), distributed by Cheeky Bonsai, San Francisco, California; and
• Parche Leon Pain Relieving Hot Patch, camphor 3%, menthol 1.25%, capsaicin 0.025%, 6 patches per box (NDC 55758-039-01, UPC 8 59424 00433 6), distributed by Pharmadel LLC, Georgetown, Delaware. 

Unexo Life Sciences Private Limited voluntarily initiated the recall on October 24, 2024. On November 22, 2024, the FDA designated them Class II. Per the recall classification, use of the patches may cause temporary or medically reversible adverse health consequences. While remote, a possibility of serious harm also exists.