FDA Recalls Unapproved Brain Defogger Capsules Sold Online
Palmer Natural Products is recalling Brain Defogger capsules because they were marketed without FDA approval. The product was sold in Florida, Idaho, California, and Hong Kong.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, which indicates a situation where use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences. The source text does not report any specific injuries or illnesses, aligning with a moderate severity rating for unapproved drug marketing.
Plain-English summary
The U.S. Food and Drug Administration (FDA) has issued a recall for Brain Defogger, Piracetam 390mg Choline 104mg capsules, 100 count bottle. The product is manufactured by Palmer Natural Products and marketed by BoostYourGrade, LLC in Orlando, Florida. The recall involves 4,103 bottles with all lot codes.
The recall was initiated because the products are unapproved drugs that were marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA). This means the safety, efficacy, and quality of the product have not been evaluated by the FDA.
The product was distributed in Florida, Idaho, California, and Hong Kong, and can also be ordered online. Consumers who have purchased this product should stop using it and contact the recalling firm for further instructions.
The recalled product
- Product
- Brain Defogger, Piracetam 390mg Choline 104mg capsules, 100 count bottle, OTC, BoostYourGrade, LLC, Orlando, FL. .
- Manufacturer
- Palmer Natural Products
- Category
- Drug — Unapproved Drug
- Hazard
- Affected units
- 4,103
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 lot codes.
Distribution
Part of a larger recall action
This product is one of 7 recalled by Palmer Natural Products under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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