The Recall Desk

FDA (Drugs) recall action 87624

Ummzy, LLC recalled 3 products on 2021-07-28

The FDA (Drugs) publishes a recall like this one as 3 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 3 pages.

Products
3
Announced
2021-07-28
Critical
2
Units
—

Why these products were recalled

Marketed Without An Approved NDA/ANDA: Products found to contain undeclared tadalafil and/ or sildenafil and vardenafil making them unapproved drugs for which the safety and efficacy have not been established and therefore subject to recall.

The agency’s own wording, quoted from the enforcement report.

1–3 of 3

  • CriticalFDA (Drugs)··2021-07-28

    Krazy Night Capsules Contain Undeclared Prescription Drug Ingredients

    Krazy Night capsules (1-count blister cards and 10-count boxes) are being recalled nationwide because they contain undeclared tadalafil, sildenafil, and/or vardenafil without FDA approval. These unapproved drugs have not undergone safety and efficacy review.

    Product
    Krazy Night capsule, packaged in a) 1-count per blister card and b) 10-count boxes, Manufactured by: SUM MARKETING LLC, Made in USA UPC 746695241860
    Category
    Distribution
    0 states
  • SevereFDA (Drugs)··2021-07-28

    Thumbs Up 7 Red Capsules Recalled for Undeclared Active Pharmaceutical Ingredients

    Ummzy LLC is recalling Thumbs Up 7 Red 70K capsules because they contain undeclared tadalafil and/or sildenafil and vardenafil, making them unapproved drugs with unestablished safety and efficacy.

    Product
    Thumbs up 7 Red 70K capsules, 10-count boxes, Distributed Ummzy LLC, Made in USA, UPC 617135894680.
    Category
    Distribution
    0 states
  • CriticalFDA (Drugs)··2021-07-28

    Shogun-X Capsules Recalled for Undeclared Prescription Drug Ingredients

    Shogun-X capsules have been recalled because they contain undeclared tadalafil, sildenafil, and/or vardenafil—prescription drugs not listed on the label. These are unapproved drugs whose safety and efficacy have not been established.

    Product
    Shogun-X capsules, 10-count boxes, Manufactured by Power Life Distributors, Made in USA, UPC 118122030185
    Category
    Distribution
    0 states
Ummzy, LLC recalled 3 products on 2021-07-28 · The Recall Desk