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FDA · DrugsClass I

Umary-USA.com drug recall: Unavy Acido Hialuronico

Undeclared allergens

Key facts

Agency
U.S. Food and Drug Administration (FDA)
Program
Drugs
Classification
Class I
Status
Completed
Event ID
96914
Recall initiated
May 21, 2025
Classified by FDA
Jun 24, 2025
Posted in Enforcement Report
Jun 25, 2025
Recalling firm
Umary-USA.com
Firm location
Nogales, AZ, United States
Initiated by
Voluntary: Firm initiated
Firm notified customers by
Press Release
Products in this event
2

What to do

Compare the product, lot or serial numbers below with what you have. If you use a prescription drug or medical device in this recall, talk to your pharmacist or health care provider before you stop using it, and follow the firm's instructions.

View the official FDA record ↗

Reason for recall

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

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

What the classification means

  • Class I: FDA's most serious category: there is a reasonable probability that using or being exposed to the product will cause serious health problems or death.

About this recall

The firm started this recall on May 21, 2025. FDA classified it 34 days later, on Jun 24, 2025. This recall event covers 2 separate products, each with its own FDA recall number. Distribution reported by FDA: U.S. Nationwide via internet.

Recalled products (2)

  • D-0492-2025 Class I Completed

    UNAVY ACIDO HIALURONICO, Conenido: 30 capletas de 850mg, distribuido por: EREN NATURAL S.A. DE C.V, Zappan, Jal. C.P, UPC 7 503046 054295

    Codes / lots: All Lots; All Expiration Dates.

    Quantity: 1,342 30-count bottles

  • D-0493-2025 Class I Completed

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

    Codes / lots: All Lots; All Expiration Dates.

    Quantity: 1,704 30-count bottles

Source and freshness

Source
U.S. Food and Drug Administration (FDA) Enforcement Report, via the openFDA drug enforcement dataset
Official notice
FDA Enforcement Report, event 96914
Raw record
openFDA API (JSON)
Dataset last updated by FDA
Nov 3, 2026
Imported by RecallRadar
Nov 4, 2026

Enforcement Report entries describe recalls FDA has classified. They are not always the same as a company press release. If something here differs from FDA's record, FDA's record is correct — please tell us.