The Recall Desk
CriticalFDA (Drugs)·D-0962-2016·Announced 2016-06-15

FDA Recalls Thermo FX Supplement for Unapproved Salicylic Acid

Novacare, LLC is recalling The People's Chemist Thermo FX Barely Legal Thermogenic Aid because FDA sampling confirmed the presence of salicylic acid in the product.

What this means for you

Highest-severity recall. Risk of serious injury or death is documented or strongly suspected. Stop using the product now and follow the agency's instructions.

Our severity reasoning: The source text explicitly states the agency classification is Class I, which mandates a severity score of 5 according to the rubric.

Plain-English summary

Novacare, LLC is recalling The People's Chemist Thermo FX Barely Legal Thermogenic Aid, packaged in 90 capsule containers. The product was manufactured by TPC, LLC and identified by UPC 793573902665. The recall is being conducted because the product was marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA).

The FDA conducted sampling of the dietary supplements and confirmed the presence of salicylic acid. The recall is classified as Class I by the FDA. The product was distributed nationwide.

Consumers who have purchased this product should stop using it and contact the recalling firm for further instructions. The source text does not report any specific illnesses or injuries associated with this recall.

The recalled product

Product
The People's Chemist Thermo FX Barely Legal Thermogenic Aid, packaged in 90 capsule containers. Manufactured by TPC, LLC, www.thepeopleschemist.com.
Manufacturer
Novacare, LLC

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 (1)

  • UPC 793573902665

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 13 recalled by Novacare, LLC 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.

See all 13 products in this recall →