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FDA (Food enforcement)Recalled 2013-11-09closedclass i

USPlabs, LLC: USPlabs OxyELITE Pro Ultra-Intense Thermo Advanced Formula DIETARY SUPPLEMENT Manufactured for USPlabs, LLC (Dallas, TX 75220), sold in the following sizes: 3 count; 90 count; and 180 co

Is my product affected?

USPlabs OxyELITE Pro Ultra-Intense Thermo Advanced Formula DIETARY SUPPLEMENT Manufactured for USPlabs, LLC (Dallas, TX 75220), sold in the following sizes: 3 count; 90 count; and 180 count.

  • UPC 094922447883
  • UPC 094922447876
  • UPC 094922395627
  • UPC 094922447869

Check against the official notice below — it lists the full affected range.

What happened

USPlabs, LLC is recalling OxyELITE Pro Ultra-Intense Thermo Advanced Formula dietary supplement products after receiving a notification from the FDA. The recall affects approximately 1,065,783 units sold worldwide in 3-count, 90-count, and 180-count capsule packages. The products are being recalled because they contain Aegeline and have been associated with serious adverse health events, including serious liver damage and acute liver failure.

The recalled products were distributed internationally to Ecuador, Russia, the UAE, South America, Dominican Republic, Kuwait, Philippines, Indonesia, Egypt, Panama, China, and Argentina. Consumers can identify affected products by the following UPCs: 094922447883 and 094922447876 (3-count), 094922395627 (90-count), and 094922447869 (180-count). The source document does not specify what consumers should do with recalled products.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

USPlabs, LLC received a 423(a), Notification of Opportunity to Initiate a Voluntary Recall, letter from FDA and is recalling products containing Aegeline and associated with serious adverse health events, namely serious liver damage or acute liver failure.

Details from the source

Reason for recall: USPlabs, LLC received a 423(a), Notification of Opportunity to Initiate a Voluntary Recall, letter from FDA and is recalling products containing Aegeline and associated with serious adverse health events, namely serious liver damage or acute liver failure. Distribution: Worldwide distribution including the following Worldwide distribution including the following international countries: Ecuador, Russia, UAE, South America, Dominican Republic, Kuwait, Philippines, Indonesia, Egypt, Panama, China, and Argentina. Quantity: 1,065,783 units Lot/code info: 3 count capsules, UPC #094922447883; 3 count capsules UPC #094922447876; 90 count capsules, UPC #094922395627; 180 count capsules UPC #094922447869

Source

Official record: FDA (Food enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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