PlainRecalls
CriticalClass ITerminated

FDA Drug recall · Reported June 5, 2019

The Beast, The Beast can be taken under the situation of Heart disease and even after drinking, 4600 mg X 4 Capsules per packet.

Marketed without an Approved NDA/ANDA: The Beast contains undeclared sildenafil which was discovered through FDA analysis.

Recall #
D-1321-2019
Affected scope
1000 boxes
Initiated
May 6, 2019
Verify with FDA Drug →
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Stiff Boy LLC recalled The Beast, The Beast can be taken under the situation of Heart disease and even after dri… - a critical-severity action.

The Beast, The Beast can be taken under the situation of Heart disease and even after dri… was recalled by Stiff Boy LLC in June 5, 2019. Reason: Marketed without an Approved NDA/ANDA: The Beast contains undeclared sildenafil which was discovered through …. Check the official notice for the remedy. Verify recall #D-1321-2019 with the FDA Drug before acting.

The recall

Stiff Boy LLC issued this critical-severity FDA Drug recall-Marketed without an Approved NDA/ANDA: The Beast contains undeclared sildenafil which was discovered through ….

Critical
severity level
Class I
classification
June 5, 2019
reported

Sourced from official FDA Drug enforcement records. Verify recall #D-1321-2019 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.

Recall Insight

This FDA Drug action (record #D-1321-2019) was formally reported on June 5, 2019, with the manufacturer initiating the action on May 6, 2019. It is classified under Critical severity (Class I), with a current status of Terminated. Stiff Boy LLC is listed as the recalling firm, operating out of Englewood, NJ. Federal records list the affected scope as 1000 boxes.

The documented reason for this recall is: Marketed without an Approved NDA/ANDA: The Beast contains undeclared sildenafil which was discovered through FDA analysis. Distribution data in the federal record shows the product reached: 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, 6 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 - 14,436 drugs & medications recalls on record

05001,0001,5002,000 2006201220152018202120242026 413
Severity1902064468High severity (most serious)Moderate severityLow severity
Where this agency-classified recall sits among FDA Class I/II/III notices

Of 88,001 recalls with an agency hazard classification, 19,020 are high severity, 64,468 moderate, and 4,513 low. A further 16,157 CPSC/NHTSA recalls have no agency class and are excluded from this split. 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.

Product description

The Beast, The Beast can be taken under the situation of Heart disease and even after drinking, 4600 mg X 4 Capsules per packet.

Reason for recall

Marketed without an Approved NDA/ANDA: The Beast contains undeclared sildenafil which was discovered through FDA analysis.

Recall Profile

Structured summary of the FDA Drug recall record
Attribute Value
Agency U.S. Food and Drug Administration
Severity class Critical (Class I)
Status Terminated
Recall number D-1321-2019
Date reported June 5, 2019
Date initiated May 6, 2019
Recalling firm Stiff Boy LLC
Firm location Englewood, NJ
Affected scope 1000 boxes
Distribution 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-1321-2019) 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?
The Beast, The Beast can be taken under the situation of Heart disease and even after drinking, 4600 mg X 4 Capsules per packet.. Recalled by Stiff Boy LLC. Units affected: 1000 boxes.
Why was this product recalled?
Marketed without an Approved NDA/ANDA: The Beast contains undeclared sildenafil which was discovered through FDA analysis.
Which agency issued this recall?
This recall was issued by the FDA Drug on June 5, 2019. Severity: Critical. Recall number: D-1321-2019.
Where was the recalled product distributed?
Distribution: Nationwide.
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.

Nationwide recalls with similar severity or category timing

Drug and device notices outside this firm and state, matched by severity timing and product category.

Similar severity · nearest report date

Same archive severity grade (Critical), closest by report date among other firms and states.

Similar Drugs & Medications · nearest report date

Same product category, closest by report date among other firms and states (deduped against the severity set).

Compare this recall with Rohto Cooling Eye Drops Max Strength (naphazoline hydrochlo… → · All Drugs & Medications recalls

This recall: FDA Drug, reported June 5, 2019. Severity classes follow each agency's own taxonomy; related-recall context is computed across the full archive.

Methodology · Corrections · Archive as of August 2026