Recalled by USPlabs, LLC · Dallas, TX, United States
Class I — High risk. Reasonable probability of serious harm or death.
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.
See the recall's own reason text for the specifics. All other reasons recalls.
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.
Quantity: 1,065,783 units
Food: Dietary supplements
A recall covers only these codes. Compare them with the lot number, best-by date or UPC printed on your package.
3 count capsules, UPC #094922447883; 3 count capsules UPC #094922447876; 90 count capsules, UPC #094922395627; 180 count capsules UPC #094922447869
FDA's distribution note: 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.
Do not eat it. Class I means FDA judged there is a reasonable probability of serious illness or death. If the brand, size and lot or date code on your package match, throw the product away or return it to the store for a refund, and clean any surface or container it touched. If anyone has eaten it and feels unwell, contact a doctor and mention the recall. FDA lists this recall as terminated: the company has finished removing the product, so it should no longer be on shelves - but it can still be in a freezer or pantry.
FDA files each product of one recall action separately; these share the same FDA event.
Reason 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…
Reason 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…
Reason 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…
Reason 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…
Reason 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…
Reason 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…
Reason Label does not declare walnuts in English
Reason Label does not declare walnuts in English
Reason Label does not declare walnuts in English
Reason Possible Salmonella in Moringa Leaf Powder product.