FDA Recalls Unapproved Nootropa Cognitive Enhancement Supplement
Palmer Natural Products is recalling Nootropa Cognitive Enhancement Supplement because it was marketed without an approved NDA/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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classification is FDA Class II, which corresponds to a severity score of 4 (Severe) per the rubric.
Plain-English summary
Palmer Natural Products is recalling Nootropa Cognitive Enhancement Supplement, 400 mg Aniracetam Capsules, 60 count bottle. The recall involves 672 bottles of the product.
The FDA is recalling the product because it was marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA), making it an unapproved drug.
The product was distributed in Florida, Idaho, California, and Hong Kong, and can be ordered online. Consumers should stop using the product and contact the recalling firm for instructions.
The recalled product
- Product
- NOOTROPA COGNITIVE ENHANCEMENT SUPPLEMENT, 400 mg Aniracetam Capsules 60 count bottle, OTC Manufactured & Packaged in the USA for NOOTROPA.COM. DEVELOPED BY: Digital Superfuture Limited Arntel Building 9B 148 Des Voeux Rd. Hong Kong.
- Manufacturer
- Palmer Natural Products
- Category
- Drug — Unapproved Drug
- Hazard
- Affected units
- 672
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)
- Lot HJLA
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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