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

USPlabs, LLC: USPlabs OxyELITE Pro Super Thermo DIETARY SUPPLEMENT Manufactured for USPlabs, LLC (Dallas, TX 75220), distributed in the following sizes: 2 count capsules; 10 count capsules; 21 count c

Is my product affected?

USPlabs OxyELITE Pro Super Thermo DIETARY SUPPLEMENT Manufactured for USPlabs, LLC (Dallas, TX 75220), distributed in the following sizes: 2 count capsules; 10 count capsules; 21 count capsules; 90 count capsules; and 180 count capsules.

  • UPC 094922417275
  • UPC 094922417251
  • UPC 094922417268
  • UPC 094922426604
  • UPC 094922395573
  • UPC 094922447906
  • UPC 094922447852

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

What happened

USPlabs, LLC is recalling OxyELITE Pro Super Thermo dietary supplement in multiple package sizes (2, 10, 21, 90, and 180 count capsules) after receiving a recall notification letter from the FDA. The recall affects approximately 2,166,328 units that were distributed worldwide, including in Ecuador, Russia, the UAE, South America, Dominican Republic, Kuwait, Philippines, Indonesia, Egypt, Panama, China, and Argentina. The product contains Aegeline and has been associated with serious adverse health events, specifically serious liver damage and acute liver failure.

The affected products are identified by their UPC codes: 094922417275 (2 count), 094922417251 (10 count), 094922417268 (10 count), 094922426604 (21 count), 094922395573 (90 count), 094922447906 (90 count, pink label), and 094922447852 (180 count). The source document does not specify what consumers should do if they have purchased this product.

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: 2,166,328 units Lot/code info: 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

Source

Official record: FDA (Food enforcement) ↗

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

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