Agency classClass IOur severity:Severe FDA (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.

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 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. 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…
Manufacturer: Performance Plus Marketing, Inc.
Category: Drug — Unapproved Dietary Supplement
Hazard: undeclared-ingredients
unapproved-drug
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 →

Same manufacturer · Performance Plus Marketing, Inc.

See all →

Critical
FDA Recalls Mojo Nights Capsules for Unapproved Active Ingredients
FDA (Drugs) · 2013-05-22
Critical
Casanova Capsules Recalled for Undeclared Sildenafil and Tadalafil
FDA (Drugs) · 2013-05-22
Critical
FDA Recalls Blue Diamond Pill for Undeclared Sildenafil and Tadalafil
FDA (Drugs) · 2013-05-22
Severe
Mojo nights SUPREME Capsules Recalled for Undeclared Active Ingredients
FDA (Drugs) · 2013-05-22
Severe
FDA Recalls Libigrow Capsules for Undeclared Active Ingredients
FDA (Drugs) · 2013-05-22

Same hazard · undeclared ingredients