FDA Recalls Popular Amazon-Sold Supplements for Dangerous Hidden Drug Ingredients

Clear Facts

• The U.S. Food and Drug Administration (FDA) has expanded a recall for all lots of Umary Acido Hialuronica (Hyaluronic Acid) supplements, found to be “tainted with drug ingredients.”
• The recall now includes additional supplements sold by Main Products, Inc. on Amazon, after FDA laboratory analysis confirmed the presence of diclofenac and omeprazole, drugs not authorized for dietary supplements.
• Main Products, Inc. is coordinating with customers for the return of recalled items. Consumers have been advised to stop using these products and to consult their healthcare providers if they’ve experienced any related health issues.

When considering adding a supplement to your daily routine, it’s crucial to thoroughly investigate the brands. These supplements are not regulated by the same standards as other food and drug products, which can present some quality concerns. The FDA has the authority to act against “any adulterated or misbranded” supplements once they are on the market.

A recall was initiated last week when the FDA discovered that all lots of Umary Acido Hialuronica (Hyaluronic Acid) supplements were “tainted with drug ingredients.” This recall has since expanded to include additional supplements sold on Amazon by Main Products, Inc.

On July 22, the California-based company voluntarily recalled its Umary Acido Hialuronico, Suplemento Alimenticio/Hyaluronic Acid Dietary Supplement. This recall includes bottles of 30 tablets with 850 mg strength, sold for pain relief via Amazon.

The FDA revealed that these supplements were “tainted with the drug ingredients” diclofenac and omeprazole. The FDA statement indicated that “products containing diclofenac and omeprazole cannot be marketed as dietary supplements.” No safety or efficacy has been established for Umary, making it subject to recall.

According to the FDA, omeprazole is a proton pump inhibitor (PPI) used for treating stomach acid-related conditions. This drug could result in “serious skin reactions, abdominal pain, diarrhea, nausea, and headache,” the warning says. The FDA explains that this hidden ingredient might conceal stomach issues like erosions, ulcers, and stomach cancer, and it could also interact with other medications.

Diclofenac is classified as a non-steroidal anti-inflammatory drug (NSAID). Consuming high levels of undeclared diclofenac could lead to serious adverse events including cardiovascular, gastrointestinal, renal, and anaphylaxis in patients taking NSAIDs and/or anticoagulants, like Warfarin, those who are allergic to diclofenac, or individuals with underlying cardiovascular, gastrointestinal, renal, and hepatic illnesses.

Main Products, Inc. is emailing customers to facilitate the return of recalled products. If you have these Umary supplements at home, the FDA strongly advises you to stop using them. You can return the supplements to Amazon or return them to the address provided in the recall notice.

If you have consumed these supplements and are experiencing any related issues, the FDA recommends reaching out to your healthcare provider or physician. Any adverse events should also be reported to the FDA’s MedWatch Adverse Event Reporting program.

For any consumer queries, Main Products, Inc. can be contacted directly at [email protected]. Their team strives to respond to emails within 24 to 48 hours, as per the FDA notice.

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