The Recall Desk
CriticalFDA (Drugs)·D-0988-2015·Announced 2015-05-13

FDA Recalls Estrastain Pro-Anabolic Mass and Hardening Complex Capsules

Anabolic Science Labs LLC is recalling Estrastain Pro-Anabolic Mass and Hardening Complex capsules because they contain unapproved synthetic hormone ingredients.

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

Anabolic Science Labs, LLC is recalling Estrastain Pro-Anabolic Mass and Hardening Complex capsules. The product is manufactured for Wyked Labs LLC and contains Estra-4,9,11-triene-3,17-dione and 2a-3a-epithio-17a-methyl-5a-androstan-17b-ol. The recall involves 12,166 bottles of 60-count capsules.

The FDA is recalling these products because they were marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA). The recall is due to the presence of synthetic hormone and prohormone ingredients, specifically methylated anabolic steroids, which makes them unapproved new drugs.

The affected products were distributed nationwide in the United States and in Singapore. 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
ESTRASTAIN PRO-ANABOLIC MASS AND HARDENING COMPLEX (Estra-4,9,11-triene-3,17-dione 15mg, 2a-3a-epithio-17a-methyl-5a-androstan-17b-ol 10 mg), Capsules, 60 count bottle, Manufactured for: Wyked Labs LLC, Winter Park, FL 32789
Affected units
12,166

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 →