FDA Recall D-0492-2025
Umary-USA.com · Nogales, AZ
Class I — life-threatening Completed 358 days on record
Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence or death.
Product
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
Reason for recall
Marketed without approved NDA/ANDA- Laboratory analysis found product to be tainted with undeclared ingredients: Dexamethasone, Diclofenac and Omeprazole.
Recall record
- Recall number
D-0492-2025- Classification
- Class I
- Status
- Completed
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Press Release
- Distribution
- U.S. Nationwide via internet.
- Recall initiated
- 2025-05-21
- Classified by FDA Center
- 2025-06-24
- FDA published
- 2025-06-25
- Recalling firm
- Umary-USA.com
- Firm location
- Nogales, AZ