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Umary and Amazy are two popular branded dietary supplements sold for treatment of pain and general wellness that are associated with FDA warnings and voluntary recalls due to laboratory tests revealing unlabeled drug contents. The unreported drug substances are diclofenac (a traditional NSAID), omeprazole (a proton pump inhibitor (PPI)), and in some batches reported, dexamethasone (a corticosteroid). None of these drug substances were reported on the product label.

Umary and Amazy Product Recall Due to Hidden Drug Ingredients – 2024-2025

Recall Oct 25, 2025

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Category of the product: Dietary Supplements

Type of Recall: Warning and Voluntary Recall / Presence of Hidden Drug Ingredients

Date: 9/5/2024

Umary and Amazy are two popular branded dietary supplements sold for treatment of pain and general wellness that are associated with FDA warnings and voluntary recalls due to laboratory tests revealing unlabeled drug contents. The unreported drug substances are diclofenac (a traditional NSAID), omeprazole (a proton pump inhibitor (PPI)), and in some batches reported, dexamethasone (a corticosteroid). None of these drug substances were reported on the product label.  

Reason for warning the Products:

The undeclared ingredients can create serious health risks. Diclofenac is recognized as increasing the risks for serious cardiovascular events (heart attack and stroke) and serious gastrointestinal injury (including bleeding, ulceration and perforation) and can increase risk of serious adverse reactions with other NSAIDs or anticoagulants. Omeprazole can cause serious and severe skin reactions and gastrointestinal injury and can dull serious infections such as ulcers and cancer. Dexamethasone can suppress immunity and alter hormone levels, and stopping too fast, without weaning, can cause withdrawal. Lastly, the FDA reported receiving events from the public about each of the side effects in users of Umary and Amazy versions of the products. [1][2]

Root cause analysis:

The investigation concluded that the products were contaminated with concealed active pharmaceutical ingredients because of impotent sourcing quality assurance, testing, and manufacturing. There was inadequate verification of the ingredients and final testing of the finished products by the manufacturers to ensure the absence of prohibited drug ingredients, which resulted in contaminated finished products to have flooded the market.  [3]

Product information:

Brand / Manufacturer

Product Name

Form

Lot Numbers

Distribution Channels

SoloVital, Main Products,

Umary (various forms)

Capsules/Tablets

All lots/varieties

Amazon, SoloVital, retail stores, online

USA.COM, additional importers

Amazy (various forms)

Capsules/Tablets

All lots/varieties

Amazon, SoloVital, retail stores, online

 

(Other distributors and lot numbers may be affected; users should check with retailers and consult FDA listings for comprehensive SKU/lot information.)

Issues Identified

According to FDA analyses and adverse event surveillance, diclofenac, omeprazole, and sometimes also dexamethasone, were hidden drugs in products that were not declared to possess any pharmaceutical ingredients. Adulteration of this type increases the risk of health problems, especially for consumers who take other medications, have co-morbidities, elderly patients, and certain other populations. The FDA is treating all products (including Umary and Amazy) that contain these drugs to be adulterated.

Umary and Amazy Product Recall Due to Hidden Drug Ingredients – 2024-2025 (1)

FDA warning about the products:

  • The FDA defines these products as adulterated in the Food, Drug and Cosmetic Act (FD&C Act).
  • The hidden pharmaceuticals in supplements could pose life-threatening side effects and potential serious interactions.
  • The FDA has been actively recalling products, posting safety alerts, issuing warning letters, and educating consumers and healthcare professionals about the risks. [4]

Manufacturer / Consumer Guidance:

  • Consumers are advised to stop using Umary and Amazy products at once.
  • Consumers should return products to the place of purchase or otherwise contact the seller to obtain a refund, as appropriate.
  • Anyone who has used these products and experiences symptoms of stomach pain, chest pain, headache, skin reactions, or unexplained illness should seek medical attention and ask for evaluation and treatment for possible drug exposure.
  • Health care providers and consumers are strongly encouraged to report side effects or product concerns through the FA MedWatch Safety Information and Adverse Event Reporting Program. [5]

FRL Commentary:

This recall serves as an important reminder of the critical role of stringent ingredient verification, strong supplier controls, and final testing when manufacturing and selling dietary supplements. Regulatory oversight and Good Manufacturing practices (GMP), in conjunction with third-party analytical laboratories, are necessary to protect public health and ensure unapproved drug compounds are not sold to consumers.

Conclusion:

The recall of Umary and Amazy dietary supplements highlights the continuing struggle of how to best prevent adulteration in the dietary supplement industry. Consumers should be wary of any supplement that does not provide complete transparency of active ingredients, particularly supplements marketed for pain or other important health claims. Routine independent laboratory testing and better-quality oversight will always be necessary for consumer safety and regulatory compliance. Healthcare professionals should be aware of possible symptoms related to NSAID, PPI, and steroid exposure from dietary supplement use and advise patients accordingly.

For advanced ingredient verification and food safety analysis, contact Food Research Lab today to protect your brand and ensure consumer safety.

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