Agency classClass IOur severity:Critical FDA (Drugs)·D-0989-2015·Announced 2015-05-13

FDA Recalls Unapproved Anabolic Steroid Supplements from Anabolic Science Labs

Anabolic Science Labs is recalling SWOLL-250 Super Mass Builder Quad Stack capsules because they contain unapproved synthetic hormone ingredients.

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 SWOLL-250 Super Mass Builder Quad Stack capsules manufactured by Anabolic Science Labs, LLC for Wyked Labs. The product is a 90-count bottle of capsules containing specific synthetic hormone and prohormone ingredients, including 18-Methylestr-4-en-3-one-17b-ol, 6-a-Chloro-androst-4-en-17b-ol-3-one, 13-ethyl-3-methoxy-gona-2,5(10)-diene-17-one, and 2,17a-dimethyl-5a-androsta-1-en-17b-ol-3-one.

The recall is being conducted because the products were marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA). The presence of these synthetic hormone and prohormone ingredients makes the product an unapproved new drug. A total of 10,829 bottles were distributed nationwide in the United States and in Singapore.

Consumers who have purchased this product should stop using it immediately. The source text does not provide specific instructions for disposal or return, but the FDA generally advises consumers to contact the manufacturer or a healthcare provider for guidance on how to safely dispose of unapproved drug products.

The recalled product

Product: SWOLL-250 SUPER MASS BUILDER QUAD STACK (18-Methylestr-4-en-3-one-17b-ol 15mg, 6-a-Chloro-androst-4-en-17b-ol-3-one 15mg, 13-ethyl-3-methoxy-gona-2,5(10)-diene-17-one 15mg, 2,17a-dimethyl-5a-androsta-1-en-17b-ol-3-one 3 mg), Capsules, 90 count bottle, Manufactured for: Wyked…
Manufacturer: Anabolic Science Labs, LLC
Category: Drug — Unapproved New Drug
Hazard: unapproved-drug
synthetic-hormone
Affected units: 10,829

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 →

Same manufacturer · Anabolic Science Labs, LLC

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