The Recall Desk
SevereFDA (Drugs)·D-333-2013·Announced 2013-05-22

FDA Recalls Unapproved Libigrow XXXTREME Capsules Containing Undeclared Ingredients

The FDA is recalling Libigrow XXXTREME Capsules because they were marketed without approval and may contain undeclared sildenafil, tadalafil, and analogues.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The agency classified this as an FDA Class I recall, which the rubric defines as a minimum severity of 4 (Severe) due to the potential for serious adverse health consequences from undeclared active ingredients.

Plain-English summary

The U.S. Food and Drug Administration (FDA) is recalling Libigrow XXXTREME Capsules, Maximum Strength Formula, 1000 mg. The product is supplied in 1, 5, and 10 count blister packs and was distributed nationwide by Kretek International, Inc. The manufacturer is Performance Plus Marketing, Inc.

The recall was initiated because the product was marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA). The FDA determined that the product may contain undeclared sildenafil, tadalafil, and analogues of these FDA-approved active ingredients, making them unapproved drugs.

Consumers who have purchased these capsules should stop using them and return them to the place of purchase for a refund or contact the recalling firm for further instructions.

The recalled product

Product
libigrow XXXTREME Capsules, MAXIMUM STRENGTH FORMULA, 1000 mg, supplied in 1, 5 and 10 count blister packs, Distributed By Kretek International, Inc. Moorpark, CA 930210 1 count blister: UPC 705105830735, 5 count blister: UPC 610585435939, 10 count blister: UPC 610585435922
Manufacturer
Performance Plus Marketing, Inc.
Category
Drug — Unapproved Dietary Supplement
Hazard
Affected units
686,000

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 (11)

  • 1 count blister: Lot# 01MNU0912
  • Exp: 09/15
  • Lot# 01X0412-1
  • Exp: 04/15
  • Lot# 021647
  • Exp: 12/13
  • 5 count blister: Lot# 05X0412
  • Exp: 04/16
  • 10 count blister: Lot# 10X0412
  • Lot# 10M0111
  • Exp: 01/14.

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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