The Recall Desk
CriticalFDA (Drugs)·D-0986-2015·Announced 2015-05-13

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.

What this means for you

Highest-severity recall. Risk of serious injury or death is documented or strongly suspected. 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
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.

See all 7 products in this recall →