CLASS I Drug recall · Reported 28 May 2014 · FDA Enforcement Report

Sexy Monkey, 2000 mg blister recalled by Schindele Enterprises

Schindele Enterprises is recalling Sexy Monkey, 2000 mg blister, distributed in 13 states. The recall was initiated on 9 Jan 2014 and the FDA has classified it as Class I.

Check your package

Lot, batch or date codesNO LOT NUMBER, Exp 12/31/14

Quantity recalled2 blister packs

Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.

Recall details

Recall number: D-1336-2014
FDA event ID: 67228
Recalling firm: Schindele Enterprises, Nixa, MO
Classification: Class I
Status: Terminated
Recall initiated: 9 Jan 2014
FDA classified: 20 May 2014
Reported: 28 May 2014
Type: Voluntary: Firm initiated
Customers notified by: Press Release
Reason category: Labeling Errors

Timeline

9 Jan 2014	Recall initiated by company
20 May 2014	Classified by FDA	+131 days
28 May 2014	Published in enforcement report	+8 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Marketed Without an Approved NDA/ANDA: These dietary supplements contain undeclared sildenafil, an analogue of sildenafil, and/or tadalafil.

Product as listed by the FDA

SEXY MONKEY, 2000 mg, 1 count blister, Distributed by A Herbal Bio, Inc., Bayside, NY.

Where it was distributed

Distributed to PA, IL, TX, IA, GA, CT, FL, CA, LA, NY, MD, NV, and WI

California Connecticut Florida Georgia Iowa Illinois Louisiana Maryland Nevada New York Pennsylvania Texas Wisconsin

Questions about this recall

Is Sexy Monkey, 2000 mg blister recalled?

Yes. Schindele Enterprises recalled Sexy Monkey, 2000 mg blister on 9 Jan 2014. The recall is Class I and its status is Terminated. Recall number D-1336-2014.

Why was it recalled?

Marketed Without an Approved NDA/ANDA: These dietary supplements contain undeclared sildenafil, an analogue of sildenafil, and/or tadalafil.

Which lots are affected?

NO LOT NUMBER, Exp 12/31/14

Where was it sold?

Distributed to PA, IL, TX, IA, GA, CT, FL, CA, LA, NY, MD, NV, and WI

What should I do if I have it?

Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.

What does Class I mean?

Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

More recalls from Schindele Enterprises

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28 May 2014Drug	CLASS I	MiracleZEN Platinum, 1 pill recalled by Schindele Enterprises	Schindele Enterprises	Labeling Errors	13 states
28 May 2014Drug	CLASS I	Magic For Men recalled by Schindele Enterprises	Schindele Enterprises	Labeling Errors	13 states
28 May 2014Drug	CLASS I	Xzen Platinum, 750 mg recalled by Schindele Enterprises	Schindele Enterprises	Labeling Errors	13 states
28 May 2014Drug	CLASS I	Boost Ultra, sexual enhancement dietary supplement recalled	Schindele Enterprises	Labeling Errors	13 states
28 May 2014Drug	CLASS I	ExtenZe 600 mg recalled by Schindele Enterprises	Schindele Enterprises	Labeling Errors	13 states