Umary Acido Hialuronico recall
FDA recall D-0620-2024 · initiated Jul 12, 2024
SoloVital recalled Umary Acido Hialuronico in Jul 2024 — an FDA Class I recall (D-0620-2024) because Marketed without an Approved NDA/ANDA: FDA analysis found product to be tainted with undeclared Diclofenac and Omeprazole.
Most serious — a reasonable probability that use will cause serious harm or death.
Why it was recalled
Marketed without an Approved NDA/ANDA: FDA analysis found product to be tainted with undeclared Diclofenac and Omeprazole.
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: 1,331 bottles
Details
- Product
- Umary Acido Hialuronico, Suplemento Alimenticio, 850 mg caplets, packaged in 30-count bottles.
- Recalling company
- SoloVital
- Classification
- Class I
- Status
- Ongoing
- Type
- Voluntary: Firm initiated
- Distribution
- Nationwide within the United States
- Initiated
- Jul 12, 2024
- FDA report date
- Aug 7, 2024
Frequently asked
- Was Umary Acido Hialuronico recalled?
- SoloVital recalled Umary Acido Hialuronico in Jul 2024 — an FDA Class I recall (D-0620-2024) because Marketed without an Approved NDA/ANDA: FDA analysis found product to be tainted with undeclared Diclofenac and Omeprazole. Most serious — a reasonable probability that use will cause serious harm or death.
- Why was Umary Acido Hialuronico recalled?
- Per the FDA enforcement record, the reason for recall D-0620-2024 was: Marketed without an Approved NDA/ANDA: FDA analysis found product to be tainted with undeclared Diclofenac and Omeprazole.
- Is a recalled Umary 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 Umary Acido Hialuronico are affected?
- Distributed: Nationwide within the United States. The recall covers these lots — All lots within Expiry. 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-0620-2024.