FDA Recalls EDGE Weight Release Capsules Containing Unapproved Drugs
Detox Transforms is recalling EDGE Amplified Weight Release capsules because the product contains undeclared phenolphthalein and fluoxetine, making it an unapproved drug.
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 corresponds to a Critical severity score of 5 according to the rubric.
Plain-English summary
The U.S. Food and Drug Administration (FDA) has issued a recall for EDGE Amplified Weight Release capsules, 400 mg, 60-count bottles. The product was developed by Signature and marketed by Detox Transforms. The recall involves 150 bottles distributed nationwide.
The recall was initiated because the product was found to contain undeclared phenolphthalein and fluoxetine. The presence of these undeclared ingredients means the product is considered an unapproved drug and was marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA).
Consumers who have purchased EDGE Amplified Weight Release capsules should stop using the product immediately. The source text does not specify specific lot numbers, stating that all lots are affected. Consumers should contact the recalling firm, Detox Transforms, for further instructions on disposal or return.
The recalled product
- Product
- EDGE Amplified Weight Release capsules, 400 mg, 60-count bottle, Developed by Signature, 1027 Highway 70 W, Suite 227, Garner, NC 27529, UPC 8 52175 00417 4.
- Manufacturer
- Detox Transforms
- Category
- Drug — Weight Loss Supplement
- Affected units
- 150
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)
- Lots: ALL
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 5 recalled by Detox Transforms 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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