Safety Report: TruVision Health Dietary Supplement Capsules - recalled due to unapproved Hordenine & octodrine, USA

United States

TruVision Health LLC is recalling several dietary supplement products because they contain the unapproved dietary ingredients hordenine and/or octodrine/DMHA (1,5-Dimethylhexylamine).  The products were distributed throughout the US, Canada, Australia, New Zealand, Germany, Ireland and England.

Hordenine is possibly unsafe when taken by mouth and might cause stimulating side effects such as rapid heart rate, high blood pressure, jitteriness, nervousness, nausea, vomiting or insomnia.  These adverse events are more likely to occur in sensitive sub-populations of people such as pregnant women and consumers with cardiovascular disease.  Currently, hordenine is not an approved dietary ingredient in dietary supplements.

Octodrine or DMHA (1,5-Dimethylhexylamine) appears to be similar to another stimulant called dimethylamylamine (DMAA), which was removed from the market in certain countries due to safety concerns. In animal studies, octodrine has been found to increase heart rate, myocardial contractility, and pain threshold.  Since no data exists on its metabolic pathway in humans, the use of octodrine during exercise is potentially dangerous.  DMHA is considered to be a substance that does not meet the statutory definition of a dietary ingredient and is an unsafe food additive.

The recalled products were packaged as capsules in blister packs and cardboard cartons or as stick packs in 30 count bags. The product bears the TruVision Health or the Truvy brand name. Lot numbers are located on the end flap of the carton or the back of the bag.
Products affected are:
SKU: 1004, Description: truCONTROL 60 Count, Lot: 13580
SKU: 1005, Description: TruControl 7 Day Trifold, Lot: WKW72353
SKU: 1006, Description: reFORM, Lot: 34159
SKU: 1010, Description: truControl with Dynamine 60 ct, Lot: WK65081
SKU: 8402, Description: TruWeight and Energy Gen 2+ 60 Count, Lot: WK71567
SKU: 8403, Description: TruWeight and Energy Gen 2+ Trifold, Lot: 25173
SKU: 10000, Description: Truvy 30-Day Experience Kit, Lot: 39643/42825
SKU: 10001, Description: Truvy 7-Day Experience Kit, Lot: 41404
SKU: 10002, Description: Truvy Boost 30-Day Experience Kit, Lot: 13993
SKU: 10003, Description: TruBoost 7 Day Experience Kit, Lot: 13985
SKU: 12000, Description: TruBoost Drink - Citrine Spark, Lot: PM17921F1
SKU: 12001, Description: TruBoost Drink - Ruby Rev, Lot: PM18821F1

Consumers who have purchased these products should stop using them immediately and they are urged to return them to TruVision Health LLC for a full refund (return shipping is paid by the consumer), an exchange, or they may discard the product.

This recall was initiated after an FDA inspection determined that the products were adulterated.

Some consumers of these products have reported experiencing chest pain, chills, diarrhea, dizziness/lightheadedness, fatigue, headache, high blood pressure, high heart rate, jitters, nausea, nervousness, rash, stomach pain or upset, sweating and vomiting.

In case you experience harm from these products, it is important to report it. It can help to detect & resolve issues and prevent others from being harmed, and it enables better surveillance. If symptoms persist, seek medical care.

Company name: TruVision Health
Brand name: Truvy TruVision reFORM
Product recalled: Various Dietary Supplement Capsules
Reason of the recall: Unapproved Hordenine and octodrine/DMHA (1,5-dimethylhexylamine)
FDA Recall date: April 27, 2023

Source: www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/truvision-health-recalls-dietary-supplement-products-because-possible-health-risk