Oasis Capsules Recalled for Undeclared Sibutramine and Phenolphthalein
Bee Extremely Amazed LLC is recalling Oasis 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 severity score of 5 according to the rubric.
Plain-English summary
Bee Extremely Amazed LLC is recalling 581 bottles of Oasis Capsules, 500mg, 45-count bottles. The product was marketed as a dietary supplement but was found to be tainted with undeclared sibutramine and phenolphthalein.
Sibutramine is an appetite suppressant that was withdrawn from the US market for safety reasons. Phenolphthalein is an ingredient found in over-the-counter laxative products that was withdrawn from the US market due to concerns of carcinogenicity. The presence of these ingredients makes the product an unapproved drug.
The recall covers all lots of the product, which was distributed nationwide. Consumers should stop using the product and contact the recalling firm for further instructions.
The recalled product
- Product
- Oasis Capsules, 500mg, 45-count bottles, Manufactured for: MWN Health 37 N Orange Ave Suite 500 Orlando FL 32801 (407)930-4043
- Manufacturer
- Bee Extremely Amazed LLC
- Category
- Drug — Dietary Supplement
- Affected units
- 581
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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