The OxyElite Pro recall lawyer at The Senators Firm have many years of experience handling complex products liability cases, including numerous claims against the makers of dietary supplement products that have caused our clients to suffer serious injuries, including liver and kidney damage. If you or a loved one ingested OxyElite Pro and developed liver dysfunction or other serious injuries, let us put our experience to work for you.
What Is OxyElite Pro?
OxyElite Pro is purported to be a “dietary supplement” used to lose weight and build muscle. Over the last several years, the product has been “reformulated” by the manufacturer because of safety and other concerns. Prior to the early part of 2013, OxyElite Pro contained a stimulant-like substance called DMAA (1,3-dimethylamylamine). However, in the wake of suspicions about the origins of the DMAA as well as safety concerns raised by the United States military and others, the manufacturer “reformulated” OxyElite Pro in 2013, removing DMAA and adding a substance known as Aegeline, which is supposedly extracted from the leaves of the Bael (Aegle marmelos) tree.
Recalled OxyElite Pro Products:
- OxyElite Pro Super Thermo capsules
- OxyElite Pro Super Thermo Powder
- OxyElite Pro Ultra-Intense Thermo capsules
OxyElite Pro May Cause Serious Liver Damage
OxyElite Pro has recently been implicated in numerous cases of a serious liver disease known as “acute hepatitis.” Symptoms of hepatitis include fever, fatigue, loss of appetite, nausea, vomiting, abdominal pain, dark urine, clay colored bowel movements, joint pain, yellow eyes, and jaundice. Hepatitis may lead to irreversible and life-threatening liver failure.
On November 6, 2013, the FDA notified the manufacturer of OxyElite Pro, USPLabs, of scientific and medical data indicating a potential link between the use the product and multiple cases of serious liver diseases reported in Hawaii and investigated by the Centers for Disease Control. At least one death reportedly occurred and other patients had to undergo liver transplantation or be placed on the transplant list. The FDA also identified reports of liver damage after use of OxyElite Pro in a number of other states.
Learn More about OxyElite Pro:
- A recent CDC report discusses OxyElite Pro and its potential side effects.
- The Durbin Letter, sent to USPlabs regarding OxyElite Pro from Illinois Senator Richard Durbin
- Learn about the specific recalled OxyElite Pro items here.
- Read about the similarities between VERSA-1 and OxyElite Pro.
- Information about USPlabs LLC, the company behind OxyElite Pro.
- OxyElite Pro Litigation Updates.
The OxyElite Pro® Recall
On October 11, 2013, the FDA sent a “warning letter” to the manufacturer of OxyElite Pro in which it notified the company that the product was “adulterated” under federal law because it contained Aegeline, a new dietary ingredient “for which there is no history of use or other evidence of safety.” FDA also said that it had reviewed data “indicating a link” between the OxyElite Pro products and a number of liver illnesses, reported in Hawaii and other states, and “that failure to immediately cease distribution of these products may result in enforcement action by the FDA.”
On November 9, 2013, the manufacturer of OxyElite Pro “voluntarily” recalled certain lots of the product, including the following:
OxyElite Pro Super Thermo capsules
- 2 count capsules UPC #094922417275
- 10 count capsules UPC #094922417251
- 10 count capsules UPC #094922417268
- 21 count capsules UPC #094922426604
- 90 count capsules UPC #094922395573
- 90 count capsules “Pink label” UPC #094922447906
- 180 count capsules UPC #094922447852
OxyElite Pro Ultra-Intense Thermo capsules
- 3 count capsules UPC #094922447883
- 3 count capsules UPC #094922447876
- 90 count capsules UPC #094922395627
- 180 count capsules UPC #094922447869
OxyElite Pro Super Thermo Powder
- Fruit Punch 0.15 oz UPC #094922417237
- Fruit Punch 0.15 oz UPC #094922447517
- Fruit Punch 4.6 oz UPC #094922426369
- Fruit Punch 5 oz. UPC #094922447487
- Blue Raspberry 4.6 oz UPC #094922426376
- Grape Bubblegum 4.6 oz UPC #094922447500
- Green Apple 4.6 oz. UPC #094922426499
FDA Recommendations To Consumers
As of November 10, 2013, the FDA is advising consumers to discontinue using any dietary supplement products labeled as Oxy Elite Pro and VERSA-1 (another product that contains Aegeline). FDA further has advised consumers who believe they have been harmed by using a dietary supplement to contact their health care practitioner.
Contact An OxyElite Pro Recall Lawyer Today
If you or someone you love suffered serious liver illness or hepatitis after taking OxyElite Pro, you may be entitled to financial compensation. Contact an OxyElite pro recall lawyer see how we can help you get the compensation that you deserve.