Prime Capsules Recalled for Undeclared Sibutramine and Phenolphthalein
Bee Extremely Amazed LLC is recalling Prime Capsules because they contain undeclared sibutramine and phenolphthalein, making them unapproved drugs.
The agency’s classification
FDA (Drugs): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
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 5/5 (Critical).
Highest-severity recall. The hazard can cause serious injury or death. Stop using the product now and follow the agency's instructions.
Our severity reasoning: The agency classification is FDA Class I, which mandates a minimum severity score of 5 according to the rubric.
Plain-English summary
Bee Extremely Amazed LLC is recalling Prime Capsules, 500mg, 60-count bottles, distributed by Zagonfly. The recall involves 1,104 bottles distributed nationwide across all lots.
The product was marketed as a dietary supplement without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA). Testing revealed the product is tainted with undeclared sibutramine, an appetite suppressant previously withdrawn from the US market for safety reasons, and phenolphthalein, an ingredient previously withdrawn due to concerns of carcinogenicity. These undeclared ingredients make the product an unapproved drug.
Consumers who purchased Prime Capsules should stop using the product and contact the distributor or manufacturer for further instructions.
The recalled product
- Product
- Prime Capsules, 500mg, 60-count bottles, Distributed By Zagonfly 3129 25th St. #392 Columbus, IN 47203
- Manufacturer
- Bee Extremely Amazed LLC
- Category
- Drug — Dietary Supplement
- Affected units
- 1,104
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 lots
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 14 recalled by Bee Extremely Amazed LLC 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 14 products in this recall →Related recalls
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