Elevated risk U.S. Food and Drug Administration

Unavy Acidio Hialuronico and Umovy Acidio Hialuronico recall: The product contains undeclared Dexamethasone, Diclofenac and Omeprazole

Recall published 1+ years ago

The product contains undeclared Dexamethasone, Diclofenac and Omeprazole

Unavy & Umovy Prescription & OTC drugs — recalled prescription & otc drugsUnavy & Umovy Prescription & OTC drugs — recalled prescription & otc drugs (photo 2)Unavy & Umovy Prescription & OTC drugs — recalled prescription & otc drugs (photo 3)Unavy & Umovy Prescription & OTC drugs — recalled prescription & otc drugs (photo 4)
4 photos published by U.S. Food and Drug Administration with the recall notice.

The hazard: Undeclared allergen or ingredient

The food itself is fine. What is wrong is the label, and for the households that rely on that label it is a real risk.

What the notice says: Corticosteroid use can impair a person’s ability to fight infections and can cause high blood sugar levels, muscle injuries, psychiatric problems, and lead to cardiovascular events.

Why it matters: An ingredient that U.S. law requires to be declared is present but missing from the label. People who avoid that ingredient cannot make a safe choice from the packaging.

Symptoms and when to call a doctor

An undeclared allergen is a danger only to people allergic or intolerant to that ingredient. For everyone else the food is safe. Reactions range from an itchy mouth, hives, stomach cramps or vomiting through to anaphylaxis — swelling of the lips, tongue or throat, a tight chest, wheezing, a sudden drop in blood pressure or collapse. If anaphylaxis is suspected, use an epinephrine auto-injector straight away and call 911, even if the symptoms seem to settle, because a second wave can follow hours later.

This page is general information, not medical advice. If you feel unwell, a clinician who can see you is the only person able to judge your case.

Recall details

Published
May 21, 2025
Risk level
Elevated risk
Issued by
U.S. Food and Drug Administration
Brand
Unavy & Umovy
Product type
Prescription & OTC drugs
Distribution
Nationwide

Products covered by this recall

Unavy Acidio Hialuronico (30 caplets/850 mg) and Umovy Acidio Hialuronico (30 caplets/850 mg)

What the company announced

FOR IMMEDIATE RELEASE – Date: May 21 2025, Nogales, AZ, UMARY USA is voluntarily recalling all lots of Unavy Ácido HIALURÓNICO (30 caplets/850 mg) and Umovy Ácido HIALURÓNICO (30 caplets/850 mg) , to the consumer level. FDA laboratory analysis confirmed that these products are tainted with the drug ingredients Diclofenac, Dexamethasone and Omeprazole . Products containing Diclofenac, Dexamethasone or Omeprazole cannot be marketed as dietary supplements. UNAVY ÁCIDO HIALURÓNICO and UMOVY ÁCIDO HIALURÓNICO are unapproved new drugs for which safety and efficacy have not been established and, therefore, subject to recall.

Risk Statement: Dexamethasone is a corticosteroid commonly used to treat inflammatory conditions. Corticosteroid use can impair a person’s ability to fight infections and can cause high blood sugar levels, muscle injuries, psychiatric problems, and lead to cardiovascular events. When corticosteroids are taken for a prolonged period, or at high doses, they can suppress the adrenal gland (a disorder in which the adrenal glands do not produce enough hormones) and adverse consequences can range from limited adverse consequences to death. Additionally, abrupt discontinuation can cause withdrawal symptoms. Diclofenac is a non-steroidal anti-inflammatory drug (commonly referred to as NSAIDs). Consumption of undeclared diclofenac could result in serious adverse events that include cardiovascular, gastrointestinal, renal, and anaphylaxis in patients taking concomitant NSAIDs and/or anticoagulants, in those who have allergies to diclofenac, or those with underlying illnesses. Omeprazole is a proton pump inhibitor (commonly referred to as PPI) used to treat gastric (stomach) acid-related disorders. Consumption of undeclared omeprazole may mask stomach issues such as erosions, ulcers, and stomach cancer. Consumption of undeclared dexamethasone, diclofenac, and omeprazole can also interact with other medications and cause serious side effects. Umary- usa.com has not received any reports of adverse events related to this recall.

These products are marketed as dietary supplements for joint pain and arthritis. UNAVY ÁCIDO HIALURÓNICO is packaged in a white plastic container with a black background label, and white and yellow writing on it. The bottle has 30 caplets/ 850 mg. The affected product includes all lots and expiration dates. UMOVY ÁCIDO HIALURÓNICO is a black plastic bottle with a black label with white and blue lettering on the label. The bottle has 30 caplets/ 850mg. The affected product includes all lots and expiration dates. Product was distributed Nationwide via internet, exclusively via umary-usa.com .

Umary-usa.com is notifying its distributors and customers by Press release and email and is arranging for return and refund of all recalled products. Consumers who have any of these products, should immediately work with their physician and/or health care provider to safely discontinue use of these products. Consumers with questions regarding this recall can contact umary-usa.com at [email protected] , available seven days a week, 24 hours a day. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

Complete and submit the report Online : www.fda.gov/medwatch/report.htm1

Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm 2 or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.

Reproduced from the company announcement posted on fda.gov. Links and contact forms in the original are not repeated here; the official notice below has them.

Check your product

The notice names 1 code you can read straight off the package. Type the one printed on yours and the list below narrows to it.

Package size

Match the net weight or the piece count on the front of the pack.

  • 850 mg

Codes are lifted verbatim from the FDA — Company recall announcements notice. A code that is missing here may still be covered — the official notice is the complete list.

What to do about Allergen

Unavy & Umovy — The food itself is fine. What is wrong is the label, and for the households that rely on that label it is a real risk.

  1. Read the official notice above for the exact ingredient involved, then check whether anyone in your home avoids it.
  2. Warn anyone else who eats from your kitchen, including schools and childminders.
  3. Report any reaction to the FDA so it is recorded against this recall.
  4. If nobody here avoids it, the product is safe to eat; the refund is still available if you would rather return it.

Getting a refund without the pack

The commonest reason people skip the refund is that they have already thrown the item away. That rarely matters.

  • A photo of the label and lot code is accepted by most grocers, and so is a card statement line showing the purchase.
  • Store credit is often offered first. You can ask for the original payment method instead, and it is normally granted.
  • No photo either? Ask anyway. Grocery chains settle recall refunds at the service desk because disputing them costs more than paying them.
  • For a multi-pack or a case, ask for the full purchase price rather than a per-unit figure — the recall covers what you paid.

Remedy named in the notice: Umary-usa.com is notifying its distributors and customers by Press release and email and is arranging for return and refund of all recalled products.

Company contact: UMARY USA — Consumers: [email protected] — Media: Hugo Ramirez, 520-342-7385

The official notice

This page summarises a notice published by U.S. Food and Drug Administration. The agency notice is the authoritative version — read it before you act, and treat it as the final word if anything here looks different.

Open the FDA — Company recall announcements record U.S. Food and Drug Administration recalls

Questions people ask about this recall

Why was Unavy & Umovy prescription & otc drugs recalled?

The product contains undeclared Dexamethasone, Diclofenac and Omeprazole Corticosteroid use can impair a person’s ability to fight infections and can cause high blood sugar levels, muscle injuries, psychiatric problems, and lead to cardiovascular events.

How do I know if I have the recalled product?

The notice does not publish package codes for this recall. Compare the product name, size and the purchase window against the official FDA — Company recall announcements record, and contact the company if you are unsure.

What should I do with it right now?

Read the official notice above for the exact ingredient involved, then check whether anyone in your home avoids it.

Can I get my money back?

The notice says: Umary-usa.com is notifying its distributors and customers by Press release and email and is arranging for return and refund of all recalled products.

Where was the recalled product sold?

It was distributed nationwide.

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