Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Kool Comfort Cooling Pain Relief Recalled by US Pharmaceuticals Inc. Due to CGMP Deviations: Out of Specification results for either...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact US Pharmaceuticals Inc. directly.
Affected Products
Kool Comfort Cooling Pain Relief, 5% Menthol, Packaged in a) 3 OZ./85 g (UPC 0 52301 35903 5); b) 4 OZ/ 113 g (UPC 0 52301 36504 3); c) 32 OZ/ 907 g (UPC 0 52301 36532 6); d) 16 OZ/ 454 g (UPC 0 52301 36516 6); e) 128 OZ/ 3629 g (UPC 0 52301 36512 8) Manufactured for: Dee Cee Laboratories, Inc. 304 Dee Cee Rd., White House, TN 37188.
Quantity: 2192 cases
Why Was This Recalled?
CGMP Deviations: Out of Specification results for either total microbial count or total organic carbon in the purified water utilized in the manufacturing process.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About US Pharmaceuticals Inc.
US Pharmaceuticals Inc. has 22 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report