CLASS I Drug recall · Reported 22 May 2013 · FDA Enforcement Report

libigrow Xxxtreme Capsules, Maximum Strength Formula recalled

Performance Plus Marketing is recalling libigrow Xxxtreme Capsules, Maximum Strength Formula, 1000 mg, supplied in 1, 5, distributed nationwide in the US. The recall was initiated on 17 Dec 2012 and the FDA has classified it as Class I.

Check your package

Lot, batch or date codes1 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, Exp: 04/16; Lot# 10M0111, Exp: 01/14.
Quantity recalled686,000 capsules

Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.

Recall details

Recall number
D-333-2013
FDA event ID
63916
Recalling firm
Performance Plus Marketing, Commerce, CA
Classification
Class I
Status
Terminated
Recall initiated
17 Dec 2012
FDA classified
16 May 2013
Reported
22 May 2013
Type
Voluntary: Firm initiated
Customers notified by
Telephone
Reason category
Labeling Errors

Timeline

17 Dec 2012Recall initiated by company
16 May 2013Classified by FDA+150 days
22 May 2013Published in enforcement report+6 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Marketed Without an Approved NDA/ANDA: product may contain undeclared sildenafil, tadalafil and analogues of these FDA approved active ingredients, making them unapproved drugs

Product as listed by the FDA

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.

Where it was distributed

Nationwide

Nationwide

Questions about this recall

Is libigrow Xxxtreme Capsules, Maximum Strength Formula, 1000 mg, supplied in 1, 5 recalled?

Yes. Performance Plus Marketing recalled libigrow Xxxtreme Capsules, Maximum Strength Formula, 1000 mg, supplied in 1, 5 on 17 Dec 2012. The recall is Class I and its status is Terminated. Recall number D-333-2013.

Why was it recalled?

Marketed Without an Approved NDA/ANDA: product may contain undeclared sildenafil, tadalafil and analogues of these FDA approved active ingredients, making them unapproved drugs

Which lots are affected?

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, Exp: 04/16; Lot# 10M0111, Exp: 01/14.

Where was it sold?

Nationwide

What should I do if I have it?

Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.

What does Class I mean?

Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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