The Recall Desk
SevereFDA (Drugs)·D-0990-2015·Announced 2015-05-13

FDA Recalls Professional Formexx Black Due to Unapproved Steroid Ingredient

Anabolic Science Labs is recalling Professional Formexx Black capsules because they contain an unapproved synthetic hormone ingredient.

What this means for you

Illness, injury, or structural failure has been reported. 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 per the rubric.

Plain-English summary

The U.S. Food and Drug Administration (FDA) is recalling Professional Formexx Black capsules manufactured by Anabolic Science Labs, LLC. The product is a 60-count bottle of capsules containing AromaMaXX 250mg.

The recall is being conducted because the product contains a synthetic hormone or prohormone ingredient, specifically a methylated anabolic steroid. This presence 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 recall covers 22,353 bottles distributed nationwide in the United States and in Singapore. All lots of the product are affected. Consumers should stop using the product and contact the manufacturer for further instructions.

The recalled product

Product
PROFESSIONAL FORMEXX BLACK (AromaMaXX 250mg: 13-dimethyl-1,2,7,8,9,11,12,14,15,16-decahydro-cyclopenta[a]phenanthrene-3,6,17-trione,4-Androsten 4,17-beta-diol-3one), Capsules, 60 count bottle, Manufactured for: ANABOLIC SCIENCE LABS WINTER PARK, FL 32789
Affected units
22,353

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 →