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.
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
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
- 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
See all →- SevereImperia Elita Vitaccino Coffee Recalled for Unapproved Drug Ingredients
FDA (Drugs) · 2021-06-23
- CriticalBiotech Underground Tri-Ton Hardcore Formula Recalled for Unapproved Ingredients
FDA (Drugs) · 2017-08-23
- CriticalFDA Recalls Virilis Pro Dietary Supplement for Unapproved Drug Ingredients
FDA (Drugs) · 2014-04-23
- SevereBethel Advance capsules recalled for unapproved drug ingredients
FDA (Drugs) · 2013-12-25
Similar recalls
- CriticalFDA Recalls XtraHRD Male Enhancement Capsules for Unapproved Drug Ingredient
FDA (Drugs) · 2017-04-12
- CriticalFDA Recalls SexVoltz Herbal Supplement Containing Unapproved Tadalafil
FDA (Drugs) · 2013-09-11
- SevereFDA Recalls Unapproved MAX MAN Capsules Containing Sildenafil
FDA (Drugs) · 2018-02-07
- CriticalBody Basics Recalls Actra-SX Capsules Containing Unapproved Sildenafil
FDA (Drugs) · 2013-04-24
- CriticalFDA Recalls Vicerex Male Sexual Enhancer for Undeclared Tadalafil
FDA (Drugs) · 2014-04-16
- SevereSuper Power capsules recalled for containing unapproved sildenafil
FDA (Drugs) · 2013-05-22