USPlabs is voluntarily conducting a national recall of all lots and sizes of the OxyElite Pro dietary supplement products, according to the U.S. Food and Drug Administration.
These products contain Aegeline, a synthesized version of a natural extract from the Bael tree.
Epidemiological evidence shows that use of these products has been associated with serious adverse health consequences, namely serious liver damage or acute liver failure, concentrated in Hawaii.
Investigations are ongoing into a potential causal relationship. The company agrees with the FDA that a national recall is appropriate as a precautionary measure. Product was distributed nationwide through retail stores, mail orders and direct delivery.
The Centers For Disease Control says there have been 56 cases of liver illnesses, most of them in Hawaii. The product was already pulled off Hawaii store shelves last month.
The following OxyElite products are covered in the recall:
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
No other products produced by USPlabs are subject to recall. Consumers who have purchased the products should immediately discontinue use of the product and return it to where they purchased it for a refund. Contact your health care professional if you have experienced any adverse effects.
Consumers can contact USPlabs at 1(800) 890-3067 (Monday-Friday, 9 a.m. - 5 p.m. EST) or email@example.com. Adverse reactions may be reported to the FDA MedWatch Adverse Event Reporting program online at http://www.fda.gov/medwatch/getforms.htm, by regular mail, or by FDA's MedWatch Hotline 1-800-FDA-1088.