Agency classClass IOur severity:Severe FDA (Drugs)·D-332-2013·Announced 2013-05-22

FDA Recalls Libigrow Capsules for Undeclared Active Ingredients

Performance Plus Marketing, Inc. is recalling Libigrow capsules marketed without FDA approval. The product 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 classification is FDA Class I, which mandates a severity score of at least 4 per the rubric.

Plain-English summary

Performance Plus Marketing, Inc. is recalling Libigrow capsules, marketed as a performance enhancer, because the product was marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA). The capsules are supplied in 1, 5, and 10 count blister packs and were distributed nationwide by H & K Nutraceuticals in Los Angeles, California.

The recall is due to the potential presence of undeclared sildenafil, tadalafil, and analogues of these FDA-approved active ingredients. Because these ingredients are not declared on the label, the product is considered an unapproved drug. The recall involves approximately 610,000 capsules across various lot numbers and expiration dates.

Consumers who have purchased Libigrow capsules should stop using the product and contact the recalling firm for further instructions or a refund. The specific lot numbers and expiration dates are listed in the official recall notice.

The recalled product

Product: libigrow capsules, PERFORMANCE ENHANCER, supplied in 1, 5 and 10 count blister packs, Distributed By: H & K Nutraceuticals Los Angeles, CA 1 count blister: UPC 094922567611, 5 count blister: UPC 094922567628, 10 count blister: UPC 610585434253.
Manufacturer: Performance Plus Marketing, Inc.
Category: Drug — Unapproved Supplement
Hazard: undeclared-ingredients
unapproved-drug
Affected units: 610,000

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 (13)

1 count blister: Lot#: 791115
Exp: 12/13
Lot#: 01M0111
Exp: 01/14
Lot#: 01M0212-1
Exp: 02/15
Lot# 01M0212
Lot# 01M0611-2
Exp: 06/14
5 count blister: Lot# 05M0412
Exp: 04/16
10 count blister: Lot# 10M0412
Exp: 04/16.

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.

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Same hazard · undeclared ingredients