The Recall Desk
Agency classClass IOur severity:SevereFDA (Drugs)·D-0984-2015·Announced 2015-05-13

FDA Recalls M1-Alpha Labs Mega Mass Builder for Unapproved Steroid Ingredient

The FDA is recalling M1-Alpha Labs 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 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 severity score of at least 4 according to the rubric.

Plain-English summary

The U.S. Food and Drug Administration (FDA) is recalling M1-Alpha Labs Mega Mass Builder capsules. The product is manufactured by Anabolic Science Labs, LLC, for Wyked Labs LLC. The recall involves 3,638 bottles of the 60-count capsule product.

The recall is being conducted because the product contains a synthetic hormone or prohormone ingredient, specifically 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. All lots are affected. Consumers should stop using the product and follow instructions from the recalling firm or the FDA regarding disposal or return.

The recalled product

Product
M1-ALPHA LABS MEGA MASS BUILDER (M1A, Methyl-1-Etiocholenolol- 20mg, Epietiocholanolone) Capsules, 60 count bottle, Manufactured for: Wyked Labs LLC, Winter Park, FL 32789
Affected units
3,638

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 →

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