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.
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 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
- 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.
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