D-0492-2025 Class I
FDA drug recall D-0492-2025 was initiated by Umary-USA.com on May 21, 2025 and is designated Class I. Reason for recall: Marketed without approved NDA/ANDA- Laboratory analysis found product to be tainted with undeclared ingredients: Dexamethasone, Diclofenac and Omeprazole. Affected quantity: 1,342 30-count bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- June 25, 2025
- Initiation Date
- May 21, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1,342 30-count bottles
Product Description
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.
Distribution Pattern
U.S. Nationwide via internet.
Code Information
All Lots; All Expiration Dates.