The Recall Desk
ModerateFDA (Drugs)·D-234-2013·Announced 2013-04-10

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. .
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

Distributed in 3 states:

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.

See all 7 products in this recall →

Same manufacturer · Palmer Natural Products

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