CLASS I Drug recall · Reported 25 Jun 2025 · FDA Enforcement Report
Unavy Acido Hialuronico, Conenido: 30 capletas de 850mg recalled
Umary-USA.com is recalling Unavy Acido Hialuronico, Conenido: 30 capletas de 850mg, distribuido por: Eren Natural, distributed nationwide in the US. The recall was initiated on 21 May 2025 and the FDA has classified it as Class I.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0492-2025
- FDA event ID
- 96914
- Recalling firm
- Umary-USA.com, Nogales, AZ
- Classification
- Class I
- Status
- Completed
- Recall initiated
- 21 May 2025
- FDA classified
- 24 Jun 2025
- Reported
- 25 Jun 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Press Release
- Reason category
- Labeling Errors
Timeline
| 21 May 2025 | Recall initiated by company | |
| 24 Jun 2025 | Classified by FDA | +34 days |
| 25 Jun 2025 | Published in enforcement report | +1 day |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Marketed without approved NDA/ANDA- Laboratory analysis found product to be tainted with undeclared ingredients: Dexamethasone, Diclofenac and Omeprazole.
Product as listed by the FDA
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
Where it was distributed
U.S. Nationwide via internet.
Questions about this recall
Why was it recalled?
Marketed without approved NDA/ANDA- Laboratory analysis found product to be tainted with undeclared ingredients: Dexamethasone, Diclofenac and Omeprazole.
Which lots are affected?
All Lots; All Expiration Dates.
Where was it sold?
U.S. Nationwide via internet.
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class I mean?
Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
1 other product · FDA event 96914| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS I | Umovy Acido Hialuronico, Conenido: 30 capletas de 850mg recalled | Umary-USA.com | Labeling Errors | Nationwide |
More recalls from Umary-USA.com
All 2| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS I | Umovy Acido Hialuronico, Conenido: 30 capletas de 850mg recalled | Umary-USA.com | Labeling Errors | Nationwide |