FDA Recalls 7-Ment Alpha Advanced Mass Builder for Unapproved Steroid Ingredient
The FDA is recalling 7-Ment Alpha Advanced Mass Builder capsules because they contain an unapproved synthetic hormone ingredient.
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 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 I, which mandates a minimum severity score of 4 according to the rubric.
Plain-English summary
The U.S. Food and Drug Administration (FDA) is recalling 7-Ment Alpha Advanced Mass Builder capsules. The product is manufactured by Anabolic Science Labs, LLC for Wyked Labs LLC. The recall involves 3,808 bottles of the 90-count capsule product.
The recall is being conducted because the product contains a synthetic hormone or prohormone ingredient, specifically a methylated anabolic steroid. This ingredient makes the product an unapproved new drug, as it was marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA).
The product was distributed nationwide in the United States and in Singapore. All lots of the product are affected. Consumers should stop using the product and return it to the place of purchase or contact the recalling firm for instructions.
The recalled product
- Product
- 7-MENT ALPHA ADVANCED MASS BUILDER (7a-methyl-estra-4-en-3,17-dione 10 mg), Capsules, 90 count bottle, Manufactured for: Wyked Labs LLC, Winter Park, FL 32789
- Manufacturer
- Anabolic Science Labs, LLC
- Category
- Drug — Supplement
- Affected units
- 3,808
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 7 recalled by Anabolic Science Labs, 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.
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