UMOVY ACIDO HIALURONICO, Conenido: 30 capletas de 850mg, distribuido por: EREN NATURAL S.A. DE C.V, Zappan, Jal. C.P, UP
Summary
The FDA issued a Class I for UMOVY ACIDO HIALURONICO, Conenido: 30 capletas de 850mg, distribuido por: EREN N by Umary-USA.com. Reason: Marketed without approved NDA/ANDA- Laboratory analysis found product to be tainted with undeclared ingredients: Dexamethasone and Diclofenac..
Details
Source
Drug Recall
External ID
D-0493-2025
Action Date
2025-06-25
Status
Completed
Category
drug
Product Description
UMOVY ACIDO HIALURONICO, Conenido: 30 capletas de 850mg, distribuido por: EREN NATURAL S.A. DE C.V, Zappan, Jal. C.P, UPC 7503046054134
Lot/Code Info: All Lots; All Expiration Dates.
Quantity Affected: 1,704 30-count bottles
Reason for Recall
Marketed without approved NDA/ANDA- Laboratory analysis found product to be tainted with undeclared ingredients: Dexamethasone and Diclofenac.
Distribution
U.S. Nationwide via internet.
Type: Voluntary: Firm initiated
Recall Initiated: 2025-05-21
Company
Nogales, AZ
Context & Analysis
This is a Class I recall. Class I recalls are the most serious — there is a reasonable probability that use of or exposure to the product will cause serious health consequences or death.
This was one of 76 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
Umary-USA.com has 2 FDA actions in our database, including 2 recalls.
Frequently Asked Questions
What is a Class I recall?
A Class I recall is the most serious type. The FDA has determined there is a reasonable probability that the product will cause serious adverse health consequences or death. Consumers should stop using the product immediately.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Umary-USA.com) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Umary-USA.com have FDA actions?
Umary-USA.com has 2 FDA actions in our database, including 2 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0493-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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