November 9, 2013 – USPlabs has announced a nationwide recall for all lots and sizes of OxyElite Pro, a pre-workout dietary supplement that was recently linked to an outbreak of acute hepatitis in Hawaii. These products contain aegeline, an adultered substance that has not proven to be safe. Consumers who have purchased OxyElite Pro products included in this recall have been urged to discontinue use immediately and return the supplements to the place of purchase for a full refund.
Free Confidential Lawsuit Evaluation: If you or a loved one has been injured by OxyElite Pro, you should contact our law firm immediately. You may be entitled to compensation by filing a suit against the manufacturer and we can help.
What’s the Problem?
According to an FDA press release, USPlabs issued the OxyElite Pro recall after learning that it had been linked to a cluster of hepatitis cases in Hawaii, and that the product may be adultered with an illegal ingredient. The press release also notified the company that if it did not initiate a voluntary recall, the FDA could enforce a nationwide OxyElite Pro recall by law. The action marks the second time the administration has exercised its recall authority under the Food Safety Modernization Act (FSMA).
Products affected by this recall include:
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
OxyElite Pro Hepatitis Outbreak Still Under Investigation
In a letter to USPlabs dated November 6, the FDA informed the company that it is still investigating at least 36 cases of acute hepatitis that have been linked to OxyElite Pro over the past six months. At least two patients were required to undergo liver transplant surgeries, and one woman – a 48-year-old mother of seven – died from her injuries. The investigation into the hepatitis outbreak is a collaboration between the Hawaii Department of Health (DOH), FDA, and the Centers for Disease Control and Prevention (CDC).
On October 11, the FDA issued a warning letter to USPlabs informing the company that OxyElite Pro and another product, VERSA-1, were found to be adulterated. The supplements contained aegeline, a new dietary ingredient that lacks a history of use or other evidence of safety. The letter stated that failure to immediately cease distribution of all aegeline-containing dietary supplements may result in enforcement action.
“Although the company knows of no valid concern about the safety of aegeline or OxyElite Pro, the company has made the business decision, in light of the adverse publicity, to reformulate the product and to discontinue the use of aegeline in the United States,” USPlabs chief compliance officer Kenneth Miles wrote in a Nov. 4 letter.
Do I Have an OxyElite Pro Lawsuit?
The Product Liability & Defective Drug Litigation Group at our law firm is an experienced team of trial lawyers that focus on the representation of plaintiffs in OxyElite Pro lawsuits. We are handling individual litigation nationwide and currently accepting new OxyElite Pro injury and death cases in all 50 states.
Free Confidential Case Evaluation: Again, if you were injured by OxyElite Pro side effects, you should contact our law firm immediately. You may be entitled to compensation by filing a suit and we can help.