UMOVY ACIDO HIALURONICO recall
FDA recall D-0493-2025 · initiated May 21, 2025
Umary-USA.com recalled UMOVY ACIDO HIALURONICO in May 2025 — an FDA Class I recall (D-0493-2025) because Marketed without approved NDA/ANDA- Laboratory analysis found product to be tainted with undeclared ingredients: Dexamethasone and Diclofenac.
Most serious — a reasonable probability that use will cause serious harm or death.
Why it was recalled
Marketed without approved NDA/ANDA- Laboratory analysis found product to be tainted with undeclared ingredients: Dexamethasone and Diclofenac.
Sold unapproved, or found to contain something undeclared
The product should not have been on sale in this form — often a supplement found to contain a hidden prescription drug.
This is a manufacturing or quality failure, not a finding that the medicine is unsafe to take — across every recall we hold, none was issued for that reason. It does not mean the batch was harmless.
Is your product affected? Check the lot number
A recall covers only specific lots. Find the lot number and expiration date on your package and compare them to the affected codes below — if yours is not listed, it was not part of this recall.
Quantity recalled: 1,704 30-count bottles
Details
- Product
- UMOVY ACIDO HIALURONICO, Conenido: 30 capletas de 850mg, distribuido por: EREN NATURAL S.A. DE C.V, Zappan, Jal. C.P, UPC 7503046054134
- Recalling company
- Umary-USA.com
- Classification
- Class I
- Status
- Completed
- Type
- Voluntary: Firm initiated
- Distribution
- U.S. Nationwide via internet.
- Initiated
- May 21, 2025
- FDA report date
- Jun 25, 2025
Frequently asked
- Was UMOVY ACIDO HIALURONICO recalled?
- Umary-USA.com recalled UMOVY ACIDO HIALURONICO in May 2025 — an FDA Class I recall (D-0493-2025) because Marketed without approved NDA/ANDA- Laboratory analysis found product to be tainted with undeclared ingredients: Dexamethasone and Diclofenac. Most serious — a reasonable probability that use will cause serious harm or death.
- Why was UMOVY ACIDO HIALURONICO recalled?
- Per the FDA enforcement record, the reason for recall D-0493-2025 was: Marketed without approved NDA/ANDA- Laboratory analysis found product to be tainted with undeclared ingredients: Dexamethasone and Diclofenac.
- Is a recalled UMOVY ACIDO HIALURONICO dangerous to take?
- An FDA recall removes specific lots from the market for a defined reason and does not by itself mean the medicine is unsafe for everyone — your specific lot may never have been affected. Most serious — a reasonable probability that use will cause serious harm or death. Check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This reproduces public FDA data and is not medical advice.
- Which lots of UMOVY ACIDO HIALURONICO are affected?
- Distributed: U.S. Nationwide via internet.. The recall covers these lots — All Lots; All Expiration Dates.. Check the lot number and expiration date on your package against this list; if yours is not listed, it was not part of recall D-0493-2025.