Palmer Natural Products Recalls Unapproved Oxiracetam and Choline Capsules
Palmer Natural Products is recalling Oxiracetam & Choline capsules because they were marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA).
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
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 2/5 (Moderate).
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 risk of temporary or medically reversible adverse health consequences. The specific hazard is the marketing of unapproved drugs, which falls under moderate severity as no specific injuries or illnesses are reported in the source text.
Plain-English summary
Palmer Natural Products is voluntarily recalling Oxiracetam & Choline capsules in 30, 60, and 90-count bottles. The recall is being conducted because the products were marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA), meaning they are unapproved drugs.
The affected products were distributed in Florida, Idaho, California, and Hong Kong, and are also available for order online. The recall includes all lot codes for the 30-count, 60-count, and 90-count bottle sizes.
Consumers who have purchased these products should stop using them and contact the recalling firm for further instructions or a refund.
The recalled product
- Product
- Oxiracetam & Choline , Oxiracetam 460mg Choline 110mg capsules a) 30 count bottle, b) 60 count bottle, c) 90 count bottle, OTC, BoostYourGrade, LLC, Orlando, FL. 32826
- Manufacturer
- Palmer Natural Products
- Category
- Drug — Unapproved Drug
- Hazard
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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