Dietary Supplement Recalled for Undeclared Diclofenac and Omeprazole
SoloVital's Umary Hyaluronic Acid supplement was recalled because FDA testing found it contains undeclared Diclofenac and Omeprazole. The product, marketed without approved NDA/ANDA, affected 1,331 bottles distributed nationwide.
The agency’s classification
FDA (Drugs): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 5/5 (Critical).
Highest-severity recall. The hazard can cause serious injury or death. Stop using the product now and follow the agency's instructions.
Our severity reasoning: FDA Class I classification indicates a reasonable probability of serious adverse health consequences. The confirmed presence of undeclared pharmaceutical ingredients in a product labeled as a dietary supplement poses significant risk due to potential adverse reactions, drug-drug interactions, and contraindications for consumers.
Plain-English summary
SoloVital is recalling Umary Acido Hialuronico dietary supplement, 850 mg caplets in 30-count bottles, due to the presence of undeclared pharmaceutical ingredients. FDA analysis identified Diclofenac and Omeprazole in the product, neither of which are listed on the label.
The product was marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA). Approximately 1,331 bottles were distributed nationwide throughout the United States. All lots within the current expiration date are affected by this recall.
Diclofenac is a nonsteroidal anti-inflammatory drug (NSAID), and Omeprazole is a proton pump inhibitor. The undeclared presence of these medications poses significant risk of adverse reactions, drug interactions, and contraindications. Consumers who have purchased this product should not use it and should contact a healthcare provider if they have already consumed any of it.
The recalled product
- Product
- Umary Acido Hialuronico, Suplemento Alimenticio, 850 mg caplets, packaged in 30-count bottles.
- Manufacturer
- SoloVital
- Category
- Drug — Dietary Supplement
- Hazard
- Affected units
- 1,331
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- All lots within Expiry
Distribution
Distributed nationwide across the United States.
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