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.
What this means for you
Highest-severity recall. Risk of serious injury or death is documented or strongly suspected. 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
- diclofenac
- omeprazole
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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