UnratedDrug recall · FDA · Published March 30, 2021
Ummzy Krazy Night Capsules: Unapproved Drugs Risk
Ummzy recalls Krazy Night capsules (1-count blister cards and 10-count boxes) due to containing undeclared tadalafil/sildenafil/vardenafil without FDA approval. These products lack safety and efficacy data.
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.
Take action
Contact the company
📍Recalling firmUmmzy, LLC273 5th St, Unit A · Palisades Park, NJ 07650-2088
✎ GovInfoNow plain-language explainer
Ummzy is recalling Krazy Night capsules because they contain undeclared drugs like tadalafil and sildenafil without FDA approval. This means the products haven't been tested for safety or effectiveness, which could pose health risks. Read more at govinfonow.com/recall/36229-ummzy-krazy-night-capsules-unapproved-drugs-risk.
“Ummzy Krazy Night Capsules: Unapproved Drugs Risk.” GovInfoNow, updated October 4, 2026. https://govinfonow.com/recall/36229-ummzy-krazy-night-capsules-unapproved-drugs-risk. Based on FDA recall #D-0662-2021 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0662-2021%22&limit=1).
The FDA announced on March 30, 2021, that Ummzy, LLC voluntarily recalled Krazy Night capsules because they contained undeclared tadalafil, sildenafil, and vardenafil, making them unapproved drugs. The agency classified the recall as Class I.
How to tell if you have it
Krazy Night capsule
UPC 00746695241860
Packaged in 1-count blister cards and 10-count boxes
Manufactured by SUM MARKETING LLC
The hazard
The products were found to contain undeclared tadalafil, sildenafil, and vardenafil. The FDA stated that the safety and efficacy of these unapproved drugs have not been established.
Context
GovInfoNow's records show other recent recalls involving undeclared drug ingredients include StuffbyNainax MR 7 SUPER 700000 Capsules (2025-12-15), Buy-Herbal Kian Pee Wan Capsules (2026-03-21), and Agebox iKids-Growth Day Formula Capsules (2025-10-28).
How to tell if you have this one
Check for Krazy Night capsules in 1-count blister cards or 10-count boxes made by Ummzy. The product was manufactured in the USA with UPC 746695241860 and all lots within expiry.
Brand
Ummzy
Product
Krazy Night capsule, packaged in a) 1-count per blister card and b) 10-count boxes, Manufactured by: SUM MARKETING LLC
Category
Drug
FDA recall event · 3 products
All 3 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
Classification
Class I
Status
Terminated
Distribution
USA Nationwide
Recall number
Product, codes & lots
Quantity
D-0662-2021
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; All lots within expiry.
N/A
D-0663-2021
Shogun-X capsules, 10-count boxes, Manufactured by Power Life Distributors, Made in USA, UPC 118122030185; All lots within expiry.
364 boxes/10 capsules per box
D-0664-2021
Thumbs up 7 Red 70K capsules, 10-count boxes, Distributed Ummzy LLC, Made in USA, UPC 617135894680.; All lots within expiry.
163 boxes/10 capsules per box
Based on the official FDA remedy
What to do — step by step
Check Product Details
Look for Krazy Night capsules in 1-count blister cards or 10-count boxes with UPC 746695241860.
Where it went and when
Where it was distributed
Distributed nationwide.
Nationwide
Not listed
FDA distribution: “USA Nationwide” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 14 months after the firm started it.
1Firm started the recall
2FDA classified it Class I
3Published in FDA’s Enforcement Report
4FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #D-0662-2021 (March 30, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0662-2021 to see it in context.
Plain-language summary written by qwen3:4b on October 4, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.