FDA Recalls Supplements Sold on Amazon Over Contamination Concerns

Laboratory analysis by the FDA confirmed that the product contains the active ingredients omeprazole and diclofenac.

A bottle of the Umary supplement under recall. FDA

On Nov. 21, the U.S. Food and Drug Administration (FDA) announced the recall of hyaluronic acid supplements sold on Amazon.

The company MXBBB is voluntarily recalling one lot of “Umary” acid hyaluronic, 30 caplets (850 mg), for consumers. Laboratory analysis by the FDA confirmed that the product contains the active ingredients omeprazole and diclofenac.

What Are Diclofenac and Omeprazole?

Diclofenac, an NSAID (non-steroidal anti-inflammatory drug), poses potential risks such as increased cardiovascular events, including heart attack and stroke, and severe gastrointestinal damage, such as bleeding, ulcers, and potentially fatal perforation of the stomach and intestines.

“This hidden drug ingredient may also interact with other medications and significantly increase the risk of adverse events, particularly when consumers use multiple NSAID-containing products,” the FDA said.

Omeprazole, a proton pump inhibitor (PPI) used to treat stomach acid-related disorders, may cause serious side effects, including skin reactions, abdominal pain, diarrhea, nausea, and headaches.

“This hidden ingredient may mask stomach issues such as erosion, ulcers, and stomach cancer, and it can also interact with other medications and should not be taken with certain medications,” the FDA said.

As of publication time, MXBBB has not received any reports of adverse events associated with this recall.

What Supplements Are Being Recalled?

The affected bottles have a UPC code of 7502265120323, a lot number of 24183, and an expiration date of July 1, 2028.

According to the FDA, 321 units of the product were distributed to customers.

“MXBBB is notifying its customers by Amazon and is arranging for the return of all recalled products. Consumers that have Umary which is being recalled should stop using/return to place of purchase for a full refund,” the FDA stated in its release.

“Consumers with questions regarding this recall can contact MXBBB by email [email protected] seven days a week, 24-hours a day.”

Multiple Recalls of Umary Products This Year

This isn’t the first time this year that Umary products have been found to have the same issues. The FDA has issued multiple warnings this year regarding Umary products due to the presence of undeclared drug ingredients.

In June 2024, the FDA warned consumers against using Umary products after tests revealed hidden ingredients, again including diclofenac and omeprazole, which were not listed on the labels.

The FDA issued additional warnings in July and September 2024 after detecting more undeclared substances in products labeled Umary or Amazy by companies such as SoloVital and Main Products. The agency again highlighted that these hidden ingredients could interact with other medications, increasing the risk of severe adverse events, especially when combined with other NSAID-containing products.

Consumers are urged to stop using Umary products and consult healthcare professionals if they have concerns or experience adverse reactions. The FDA also encourages reporting side effects through its MedWatch Safety Information and Adverse Event Reporting Program.

From NTD News