CLASS I ONGOING Drug recall · Reported 7 Aug 2024 · FDA Enforcement Report
Umary Acido Hialuronico, Suplemento Alimenticio, 850 mg caplets recalled
SoloVital is recalling Umary Acido Hialuronico, Suplemento Alimenticio, 850 mg caplets, distributed nationwide in the US. The recall was initiated on 12 Jul 2024 and the FDA has classified it as Class I.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0620-2024
- FDA event ID
- 94978
- Recalling firm
- SoloVital, Chula Vista, CA
- Classification
- Class I
- Status
- Ongoing
- Recall initiated
- 12 Jul 2024
- FDA classified
- 29 Jul 2024
- Reported
- 7 Aug 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Labeling Errors
Timeline
| 12 Jul 2024 | Recall initiated by company | |
| 29 Jul 2024 | Classified by FDA | +17 days |
| 7 Aug 2024 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Marketed without an Approved NDA/ANDA: FDA analysis found product to be tainted with undeclared Diclofenac and Omeprazole.
Product as listed by the FDA
Umary Acido Hialuronico, Suplemento Alimenticio, 850 mg caplets, packaged in 30-count bottles.
Where it was distributed
Nationwide within the United States
Questions about this recall
Why was it recalled?
Marketed without an Approved NDA/ANDA: FDA analysis found product to be tainted with undeclared Diclofenac and Omeprazole.
Which lots are affected?
All lots within Expiry
Where was it sold?
Nationwide within the United States
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class I mean?
Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other Umary Acido Hialuronico recalls
All 2| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS I | Umary Acido Hialuronico, Suplemento Alimenticio, 850 mg caplets recalled | Main Products | Labeling Errors | Nationwide |