Why it was recalled
Marketed without approved NDA/ANDA- Laboratory analysis found product to be tainted with undeclared ingredients: Dexamethasone and Diclofenac.
Product description
UMOVY ACIDO HIALURONICO, Conenido: 30 capletas de 850mg, distribuido por: EREN NATURAL S.A. DE C.V, Zappan, Jal. C.P, UPC 7503046054134
Lot numbers, UPCs & expiration codes
All Lots; All Expiration Dates.
Where it was sold
U.S. Nationwide via internet.
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0493-2025
- Classification
- Class I
- Status
- Completed
- Recall initiated
- May 21, 2025
- FDA report date
- Jun 25, 2025
- Quantity
- 1,704 30-count bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Umary-USA.com
Original FDA data
Every field from FDA enforcement report D-0493-2025, exactly as published.
Show all FDA fields
- City
- Nogales
- State
- AZ
- Status
- Completed
- Country
- United States
- Event ID
- 96914
- Address
- 243 W Crawford St
- Address (line 2)
- STE 40026
- Code information
- All Lots; All Expiration Dates.
- Postal code
- 85621-3208
- Report date
- Jun 25, 2025
- Product type
- Drugs
- Recall number
- D-0493-2025
- Classification
- Class I
- Recalling firm
- Umary-USA.com
- Product quantity
- 1,704 30-count bottles
- Reason for recall
- Marketed without approved NDA/ANDA- Laboratory analysis found product to be tainted with undeclared ingredients: Dexamethasone and Diclofenac.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- UMOVY ACIDO HIALURONICO, Conenido: 30 capletas de 850mg, distribuido por: EREN NATURAL S.A. DE C.V, Zappan, Jal. C.P, UPC 7503046054134
- Distribution pattern
- U.S. Nationwide via internet.
- Recall initiation date
- May 21, 2025
- Initial firm notification
- Press Release
- Center classification date
- Jun 24, 2025