FDANovember 13, 2016drug
Ultimate Body Tox PRO capsules, Proprietary Blend, 350 mg, 45 count bottle, Manufactured for: JSN Health, 305 Broadway, 7th Floor, New York, NY 10007.
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
Marketed Without An Approved NDA/ANDA: The product contains undeclared sibutramine. The presence of sibutramine, a previously approved controlled substance that was removed from the U.S. market in October 2010 for safety reasons, in this tainted product renders it an unapproved drug for which safety and efficacy have not been established and therefore subject to recall.
What to do
FDA enforcement status: Terminated
Brands named
ultimate body toxultimateultimate body
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
- CPSCMindbodygreen Recalls Ultimate Multivitamin+ Dietary Supplement Bottles Due to Risk of Serious Injury or Death from Child Poisoning; Violates Mandatory Standard for Child-Resistant Packaging2026-01-29
- CPSCSkims Body Recalls SKIMS Children's Pajama Sets Due to Burn Hazard; Violation of Federal Regulations for Children's Sleepwear; Sold Exclusively by Skims Body2024-05-02
- CPSCSurf 9 Recalls Body Glove Tandem and ULI Inflatable Paddle Boards Due to Drowning Hazard; Sold Exclusively at Costco2022-12-29
- CPSCProfile Design Recalls Bicycle Carbon Aerobars Due to Crash Hazard2019-12-11
- CPSCAt Home Recalls Shag Rugs Due to Violation of Federal Flammability Standard; Fire Hazard2019-08-27
- CPSCRegency Fireplace Products Recalls Gas Stove Fireplaces Due to Explosion and Injury Hazards2018-05-15
- FDASkinny Bee Diet capsules, 500 mg, packaged in a 60-count bottle2016-10-28
- FDADream Body 450 mg 30 capsules in a plastic screw on top bottle2016-07-01
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