The Recall Desk
CriticalFDA (Drugs)·D-336-2013·Announced 2013-05-22

FDA Recalls Mojo Nights Capsules for Unapproved Active Ingredients

Performance Plus Marketing is recalling Mojo Nights Capsules because they may contain undeclared sildenafil, tadalafil, and analogues, making them unapproved drugs.

What this means for you

Highest-severity recall. Risk of serious injury or death is documented or strongly suspected. Stop using the product now and follow the agency's instructions.

Our severity reasoning: The agency classification is FDA Class I, which mandates a severity score of 5 according to the rubric.

Plain-English summary

Performance Plus Marketing, Inc. is recalling Mojo Nights Capsules, a male sexual enhancer product. The product is supplied in 1 and 5 count blister packs and was distributed nationwide by Mojo Health in Pompano Beach, Florida. The recall involves 219,000 capsules.

The FDA has determined that the product was marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA). The capsules may contain undeclared sildenafil, tadalafil, and analogues of these FDA-approved active ingredients. Consequently, the product is considered an unapproved drug.

Consumers who have purchased Mojo Nights Capsules should stop using the product and contact the distributor or manufacturer for further instructions. The affected lots include Lot# 01MJ0712 and 01MM0211 (1 count) with an expiration date of 07/15, and Lot# 05M0912 (5 count) with an expiration date of 10/15.

The recalled product

Product
Mojo nights Capsules, Male Sexual Enhancer, supplied in 1 and 5 count blister packs, Distributed By: Mojo Health, Pompano Beach, FL I count blister UPC - 718122119738; 5 count blister UPC - 705105836430;
Manufacturer
Performance Plus Marketing, Inc.
Category
Drug — Unapproved Sexual Enhancer
Hazard
Affected units
219,000

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 (4)

  • (1 count) Lot# 01MJ0712
  • (1 count) 01MM0211 Exp: 07/15
  • (5 count) Lot# 05M0912
  • Exp: 10/15

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 7 recalled by Performance Plus Marketing, Inc. 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 →

Related recalls

Same manufacturer · Performance Plus Marketing, Inc.

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Same hazard · undeclared ingredients

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