The Recall Desk
Agency classClass IOur severity:CriticalFDA (Drugs)·D-1336-2014·Announced 2014-05-28

Dietary Supplement Recalled for Undeclared Sildenafil and Tadalafil Analogs

Schindele Enterprises is recalling Sexy Monkey dietary supplements because they contain undeclared sildenafil, an analogue of sildenafil, and/or tadalafil.

The agency’s classification

FDA (Drugs): Class I

Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 5/5 (Critical).

Highest-severity recall. The hazard can cause serious injury or death. Stop using the product now and follow the agency's instructions.

Our severity reasoning: The agency classification is FDA Class I, which indicates a reasonable probability that use of or exposure to the violative product will cause serious adverse health consequences or death.

Plain-English summary

Schindele Enterprises dba Midwest Wholesale is recalling Sexy Monkey, 2000 mg, 1 count blister packs. The product is distributed by A Herbal Bio, Inc., in Bayside, NY. The recall involves 2 blister packs with an expiration date of 12/31/14 and no lot number.

The recall was initiated because the dietary supplements were marketed without an approved NDA/ANDA and contain undeclared sildenafil, an analogue of sildenafil, and/or tadalafil. These ingredients are prescription drugs that can have serious side effects, particularly when combined with other medications.

The product was distributed to Pennsylvania, Illinois, Texas, Iowa, Georgia, Connecticut, Florida, California, Louisiana, New York, Maryland, Nevada, and Wisconsin. Consumers should stop using the product and return it to the place of purchase for a refund or contact the recalling firm for instructions.

The recalled product

Product
SEXY MONKEY, 2000 mg, 1 count blister, Distributed by A Herbal Bio, Inc., Bayside, NY.
Manufacturer
Schindele Enterprises dba Midwest Wholesale
Category
Drug — Dietary Supplement
Hazard
Affected units
2

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (2)

  • NO LOT NUMBER
  • Exp 12/31/14

Distribution

Distributed in 13 states:

Part of a larger recall action

This product is one of 7 recalled by Schindele Enterprises dba Midwest Wholesale under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 7 products in this recall →

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