Severity
Critical
CriticalClass ITerminated
FDA Drug recall · Reported July 28, 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
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 effic…
Ummzy, LLC recalled Krazy Night capsule, packaged in a) 1-count per blister card and b) 10-count boxes, Manuf… - a critical-severity action.
Krazy Night capsule, packaged in a) 1-count per blister card and b) 10-count boxes, Manuf… was recalled by Ummzy, LLC in July 28, 2021. Reason: Marketed Without An Approved NDA/ANDA: Products found to contain undeclared tadalafil and/ or sildenafil and …. Check the official notice for the remedy. Verify recall #D-0662-2021 with the FDA Drug before acting.
The recall
Ummzy, LLC issued this critical-severity FDA Drug recall-Marketed Without An Approved NDA/ANDA: Products found to contain undeclared tadalafil and/ or sildenafil and ….
- Critical
- severity level
- Class I
- classification
- July 28, 2021
- reported
Sourced from official FDA Drug enforcement records. Verify recall #D-0662-2021 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Drug action (record #D-0662-2021) was formally reported on July 28, 2021, with the manufacturer initiating the action on March 30, 2021. It is classified under Critical severity (Class I), with a current status of Terminated. Ummzy, LLC is listed as the recalling firm, operating out of Palisades Park, NJ. Federal records list the affected scope as N/A.
The documented reason for this recall is: 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 theref… Distribution data in the federal record shows the product reached: USA Nationwide. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 5 from FDA Drug - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Drugs & Medications recalls over time
Where this recall sits in its category - 14,287 drugs & medications recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified high severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
N/A
Related Recalls
6
5 from same agency
Product description
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
Reason for recall
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.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Critical (Class I) |
| Status | Terminated |
| Recall number | D-0662-2021 |
| Date reported | July 28, 2021 |
| Date initiated | March 30, 2021 |
| Recalling firm | Ummzy, LLC |
| Firm location | Palisades Park, NJ |
| Affected scope | N/A |
| Distribution | USA Nationwide |
Profile values are sourced directly from the official FDA Drug enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (D-0662-2021) and product description against the item you own. Search the archive
- Confirm the current status with FDA Drug before acting, recall details can be updated.
- This is a Class I (high-risk) recall, stop using the product immediately and follow the disposal or return instructions. What to do next
This page summarizes the official FDA Drug record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Ummzy, LLC. Units affected: N/A.
Why was this product 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.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on July 28, 2021. Severity: Critical. Recall number: D-0662-2021.
Where was the recalled product distributed? ▼
Distribution: USA Nationwide.
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (D-0662-2021) against your product. Visit the official FDA Drug website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
Nearby Recalls in This Category
Other recalls in the same product category, useful for spotting patterns across the same defect class or manufacturer.
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Compare this recall with PRED MILD, prednisolone acetate ophthalmic suspension, USP,… →
Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Drug, reported July 28, 2021. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.