FDA Recalls Unapproved Anabolic Steroid Product HALO-70 MEGA MASS BUILDER
The FDA is recalling HALO-70 MEGA MASS BUILDER capsules because they contain an unapproved synthetic hormone ingredient, making them unapproved new 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
The U.S. Food and Drug Administration (FDA) is recalling HALO-70 MEGA MASS BUILDER capsules. The product is manufactured by Anabolic Science Labs, LLC for Wyked Labs LLC. The recall involves 515 bottles of the 60-count capsule product.
The recall is being conducted because the product contains a synthetic hormone/prohormone ingredient (4-chloro-17a-methyl-androst-1,4-diene-3b,17b-diol), which is a methylated anabolic steroid. The presence of 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. Consumers who have this product should stop using it and contact the recalling firm for instructions on how to return or dispose of the product.
The recalled product
- Product
- HALO-70 MEGA MASS BUILDER (4-chloro-17a-methyl-androst-1,4-diene-3b,17b-diol 35mg), Capsules, 60 count bottle, Manufactured for: Wyked Labs LLC, Winter Park, FL 32789
- Manufacturer
- Anabolic Science Labs, LLC
- Category
- Drug — Unapproved New Drug
- Affected units
- 515
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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