Unapproved Aniracetam and Choline Capsules Recalled by FDA
Palmer Natural Products is recalling 250 bottles of Aniracetam and Choline capsules because they were marketed without an approved NDA or ANDA.
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 typically involves a situation where use of, or exposure to, the product may cause temporary or medically reversible health consequences. The specific hazard is the marketing of unapproved drugs, which is a regulatory violation rather than a direct physical injury risk like contamination.
Plain-English summary
Palmer Natural Products is recalling 250 bottles of Aniracetam and Choline capsules. The product contains Aniracetam 460 mg and Choline 76 mg, with 180 capsules per bottle. It is distributed by BoostYourGrade, LLC in Orlando, Florida.
The FDA is recalling these products because they are unapproved drugs that were marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA). The recall includes all lot codes.
The product was distributed in Florida, Idaho, California, and Hong Kong, and can also be ordered online. Consumers who have this product should stop using it and contact the recalling firm for instructions.
The recalled product
- Product
- Aniracetam and Choline, Aniracetam 460 mg, Choline 76 mg, 180 capsules per bottler, non-Rx, distributed by BoostYourGrade, BoostYourGrade, LLC Orlando, FL
- Manufacturer
- Palmer Natural Products
- Category
- Drug — Unapproved Drug
- Hazard
- Affected units
- 250
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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