The Recall Desk
CriticalFDA (Drugs)·D-0472-2017·Announced 2017-02-22

MS Bionic Recalls MegaJex Herbal Supplement Containing Unapproved ED Drugs

MS Bionic is recalling MegaJex Herbal Supplement because it contains sildenafil and tadalafil, active ingredients in approved erectile dysfunction drugs, without FDA approval.

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

MS Bionic is recalling 100 bottles of MegaJex Herbal Supplement, Maximum Formula for Men, Fast acting, Increase Stamina, 20 capsules. The product was distributed in California. All lots have an expiration date of 12/2019.

The recall is being conducted because the product was marketed without an Approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA). The supplement contains sildenafil and tadalafil, which are active pharmaceutical ingredients in FDA-approved drugs used to treat erectile dysfunction (ED).

Consumers who purchased this product should stop using it and contact the recalling firm for further instructions.

The recalled product

Product
MegaJex Herbal Supplement, Maximum Formula for Men, Fast acting, Increase Stamina, 20 capsules, MS Bionics, Gardena, CA
Manufacturer
MS Bionic
Category
Drug — Herbal Supplement
Hazard
Affected units
100

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 exp. date 12/2019

Distribution

Distributed in 1 state:

Related recalls

Same hazard · unapproved drug ingredients

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