Highest risk U.S. Food and Drug Administration

UMARY Hyaluronic Acid tablets recall: The product contains undeclared diclofenac and omeprazole

Recall published 1+ years ago

The product contains undeclared diclofenac and omeprazole

Umary Prescription & OTC drugs — recalled prescription & otc drugs
Photo 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: NSAIDs may cause increased risk of cardiovascular events, such as heart attack and stroke, as well as serious gastrointestinal damage, including bleeding, ulceration, and fatal perforation of the stomach and intestines.

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
November 21, 2024
Risk level
Highest risk
Issued by
U.S. Food and Drug Administration
Brand
Umary
Product type
Prescription & OTC drugs
Distribution
Nationwide
Sold at
Amazon
UPC codes
7502265120323

Products covered by this recall

UMARY Hyaluronic Acid tablets

What the company announced

MXBBB is voluntarily recalling 1 lot of UMARY ACID HYALURONIC, 30 CAPLETS 850 MG to the consumer level. The products have been found to have omeprazole and diclofenac. FDA did a laboratory analysis that confirmed that Umary contains diclofenac and omeprazole.

Risk Statement: The product Diclofenac is a non-steroidal anti-inflammatory drug (commonly referred to as NSAIDs). NSAIDs may cause increased risk of cardiovascular events, such as heart attack and stroke, as well as serious gastrointestinal damage, including bleeding, ulceration, and 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. Omeprazole is a proton pump inhibitor (commonly referred to as PPI) used to treat gastric (stomach) acid-related disorders. PPI medicines may cause serious 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. MXBBB has not received any reports of adverse events related to this recall till date.

UMARY was distributed Nationwide Via Amazon.

The product is used as dietary supplement and is packaged in a plastic container. The affected UMARY Acid hyaluronic. UPC:7502265120323 30 caplets of 850mg include the following Lot number: 24183 and the expiration date: 07/01/28. 321 units were distributed.

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. 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.

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

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

Regular Mail or Fax: Download form 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 4 codes you can read straight off the package. Type the one printed on yours and the list below narrows to it.

UPC / barcode

Read the twelve digits under the barcode on the package.

  • 7502265120323

Lot or batch code

Usually ink-stamped near the seam, the cap or the bottom of the pack.

  • 30 CAPLETS 850 MG
  • 24183

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

Umary — 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. Report any reaction to the FDA so it is recorded against this recall.
  3. If nobody here avoids it, the product is safe to eat; the refund is still available if you would rather return it.
  4. If someone does avoid it, stop serving it and check anything already cooked with 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: Consumers that have Umary which is being recalled should stop using/return to place of purchase for a full refund.

Company contact: MXBBB — Consumers: Joshua Montoya, 915-258-6936, [email protected]

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 Umary prescription & otc drugs recalled?

The product contains undeclared diclofenac and omeprazole NSAIDs may cause increased risk of cardiovascular events, such as heart attack and stroke, as well as serious gastrointestinal damage, including bleeding, ulceration, and fatal perforation of the stomach and intestines.

How do I know if I have the recalled product?

Match the codes printed on your package against the notice: UPC 7502265120323; lot code 30 CAPLETS 850 MG, 24183. If the code on your package is not on that list, your unit is outside the recall.

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: Consumers that have Umary which is being recalled should stop using/return to place of purchase for a full refund.

Where was the recalled product sold?

It was distributed nationwide, including at Amazon.

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