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Drug FDA Class I Completed Mislabeling

UMOVY ACIDO HIALURONICO, Conenido: 30 capletas de 850mg, distribuido por: EREN NATURAL S.A. DE C.V, Zappan, Jal. C.P, UPC 7503046054134

Umary-USA.com Published Jun 25, 2025

Risk level

Class I

Dangerous or defective — could cause serious health problems or death.

Severity score 80/100

What should you do?

  • Check whether you have this product, using the lot codes, UPCs, and dates listed below.
  • Do not eat, serve, or sell the affected product.
  • Return it to the place of purchase for a refund, or throw it away in a sealed bag so people and animals can’t get to it.
  • Contact Umary-USA.com or your place of purchase with questions, and see the source record below for full details.
Reason for recall

Marketed without approved NDA/ANDA- Laboratory analysis found product to be tainted with undeclared ingredients: Dexamethasone and Diclofenac.

Hazards

Dexamethasone · primaryDiclofenac

Affected products (1)

UMOVY ACIDO HIALURONICO, Conenido: 30 capletas de 850mg, distribuido por: EREN NATURAL S.A. DE C.V, Zappan, Jal. C.P, UPC 7503046054134

1,704 30-count bottles

Code info: All Lots; All Expiration Dates.

Affected areas

Nationwide

Timeline

  1. Initiated
    May 21, 2025
  2. Published
    Jun 25, 2025
Recall number
D-0493-2025
Agency
U.S. Food and Drug Administration
Country
US
Source data (openFDA JSON) About FDA enforcement reports

FDA records come from the openFDA drug enforcement-report dataset — the agency's full weekly enforcement list. Most entries are not issued as consumer press releases, so they won't appear on fda.gov/recalls or in a web search. The source record link above resolves this exact recall by its number.