FDA Drugs recall ·
UMOVY ACIDO HIALURONICO, Conenido: 30 capletas de 850mg… recall
This is an FDA Class I recall — the most serious type.
- Recall number
- D-0493-2025
- Date
- (initiated May 21, 2025)
- Company / brand
- Umary-USA.com
243 W Crawford St, Nogales, AZ, United States - Category
- Drugs › Class I
- Classification
- Class I
- Status
- Completed
- Units affected
- 1,704 30-count bottles
- Hazard tags
- Undeclared allergen
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
UMOVY ACIDO HIALURONICO, Conenido: 30 capletas de 850mg, distribuido por: EREN NATURAL S.A. DE C.V, Zappan, Jal. C.P, UPC 7503046054134
Why was it recalled?
Marketed without approved NDA/ANDA- Laboratory analysis found product to be tainted with undeclared ingredients: Dexamethasone and Diclofenac.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
All Lots; All Expiration Dates.
Distribution
U.S. Nationwide via internet.
What does Class I mean?
Class I is the most serious FDA recall class: there is a reasonable probability that using or being exposed to the product will cause serious adverse health consequences or death.
Source: FDA (drugs), recall D-0493-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.