PlainRecalls
CriticalClass ITerminated

FDA Drug recall · Reported December 25, 2013

Evil Root 1200 mg, supplied in 6 capsules per bottle, Manufacturer: Tibet Shengyang Health Medicine Co.,Ltd. Address: No. 98, Min zu Road, Lhasa

Marketed without an Approved NDA/ANDA: product found to contain undeclared sildenafil

Recall #
D-376-2014
Affected scope
32 bottles of 6 capsules each
Initiated
August 14, 2013
Compiled from official public sources by the editorial team.
Verify with FDA Drug →
View my saved recalls

Fabscout Entertainment, Inc recalled Evil Root 1200 mg, supplied in 6 capsules per bottle, Manufacturer: Tibet Shengyang Healt… - a critical-severity action.

Evil Root 1200 mg, supplied in 6 capsules per bottle, Manufacturer: Tibet Shengyang Healt… was recalled by Fabscout Entertainment, Inc in December 25, 2013. Reason: Marketed without an Approved NDA/ANDA: product found to contain undeclared sildenafil. Check the official notice for the remedy. Verify recall #D-376-2014 with the FDA Drug before acting.

The recall

Fabscout Entertainment, Inc issued this critical-severity FDA Drug recall-Marketed without an Approved NDA/ANDA: product found to contain undeclared sildenafil.

Critical
severity level
Class I
classification
December 25, 2013
reported

Sourced from official FDA Drug enforcement records. Verify recall #D-376-2014 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.

Recall Insight

This FDA Drug action (record #D-376-2014) was formally reported on December 25, 2013, with the manufacturer initiating the action on August 14, 2013. It is classified under Critical severity (Class I), with a current status of Terminated. Fabscout Entertainment, Inc is listed as the recalling firm, operating out of Ft Lauderdale, FL. Federal records list the affected scope as 32 bottles of 6 capsules each.

The documented reason for this recall is: Marketed without an Approved NDA/ANDA: product found to contain undeclared sildenafil Distribution data in the federal record shows the product reached: CA, FL and UT. 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 - 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.

Children & Baby Products recalls over time

Where this recall sits in its category - 3,731 children & baby products recalls on record

0100200300400500600 20052008201120142017202020232026 146
Severity2487872426High severity (most serious)Moderate severityLow severity
Where this recall sits in the database

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.

Severity

Critical

Affected scope

32 bottles of 6 capsules each

Related Recalls

6

0 from same agency

Product description

Evil Root 1200 mg, supplied in 6 capsules per bottle, Manufacturer: Tibet Shengyang Health Medicine Co.,Ltd. Address: No. 98, Min zu Road, Lhasa

Reason for recall

Marketed without an Approved NDA/ANDA: product found to contain undeclared sildenafil

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-376-2014
Date reported December 25, 2013
Date initiated August 14, 2013
Recalling firm Fabscout Entertainment, Inc
Firm location Ft Lauderdale, FL
Affected scope 32 bottles of 6 capsules each
Distribution CA, FL and UT

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-376-2014) 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?
Evil Root 1200 mg, supplied in 6 capsules per bottle, Manufacturer: Tibet Shengyang Health Medicine Co.,Ltd. Address: No. 98, Min zu Road, Lhasa. Recalled by Fabscout Entertainment, Inc. Units affected: 32 bottles of 6 capsules each.
Why was this product recalled?
Marketed without an Approved NDA/ANDA: product found to contain undeclared sildenafil
Which agency issued this recall?
This recall was issued by the FDA Drug on December 25, 2013. Severity: Critical. Recall number: D-376-2014.
Where was the recalled product distributed?
Distribution: CA, FL and UT.
How do I check if my product is affected by a recall?
Check the product description and recall number (D-376-2014) 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.

Compare this recall with AMASKY Nursing Pillows Recalled Due to Risk of Serious Inju… →

Browse all Children & Baby Products recalls →

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 December 25, 2013. 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.