FDA Expands Nationwide Recall of Supplements "Tainted With Drug Ingredients"

While your doctor might recommend adding a supplement to your daily routine, you'll want to do your due diligence when researching brands. These pills and powders aren't regulated under the same standards as other food and drug products, meaning that their quality is sometimes called into question. The U.S. Food and Drug Administration (FDA) has the authority to take action against "any adulterated or misbranded" supplements after they hit the market. Just last week, a recall was prompted when the agency found that all lots of Umary Acido Hialuronica (Hyaluronic Acid) supplements were "tainted with drug ingredients." Now, the recall has been expanded to include additional supplements sold on Amazon.

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In a July 22 recall notice, California-based company Main Products, Inc. announced the voluntary recall of all lots of its Umary Acido Hialuronico, Suplemento Alimenticio/Hyaluronic Acid Dietary Supplement. The recalled bottles contain 30 tablets with 850 mg strength. The supplements were sold to treat pain and distributed online via Main Products, Inc. on Amazon. The previous FDA recall from July 15 applied to the same Umary supplements that were distributed online by SoloVital.com.

The Umary supplement recall was initiated after FDA laboratory analysis confirmed that the products were "tainted with the drug ingredients" diclofenac and omeprazole.

"Products containing diclofenac and omeprazole cannot be marketed as dietary supplements," the July 22 FDA notice states. "Umary is an unapproved new drug for which safety and efficacy have not been established and, therefore, subject to recall."ae0fcc31ae342fd3a1346ebb1f342fcb

According to the FDA, omeprazole is a proton pump inhibitor (PPI) that is used to treat stomach acid-related disorders. The drug can cause different conditions, including "serious skin reactions, abdominal pain, diarrhea, nausea, and headache," the notice states.

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

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Diclofenac, on the other hand, belongs to the class of drugs called non-steroidal anti-inflammatory drugs (NSAIDs).

"There is a reasonable probability that consumption of high levels of undeclared diclofenac could result in serious adverse events that include cardiovascular, gastrointestinal, renal, and anaphylaxis in patients taking concomitant NSAIDs and/or anticoagulants, such as Warfarin, in those who have allergies to diclofenac, or those with underlying cardiovascular, gastrointestinal, renal, and hepatic illnesses," the FDA warns.

Main Products, Inc. is emailing customers to arrange for the return of recalled products. In the meantime, if you have any of these Umary supplements at home, the FDA asks that you stop using them. You can either return the supplements to Amazon or mail them to the address provided in the recall notice.

If you have taken these supplements and experienced any problems that may be related to use, the FDA advises you to contact your healthcare provider or physician. Adverse events should also be reported to the FDA's MedWatch Adverse Event Reporting program online or via regular mail or fax.

Consumer questions can be posed to Main Products, Inc. directly at [email protected]. The company will respond to emails within 24 to 48 hours, the FDA notice states.