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
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 2012 | Recall initiated by company | |
| 16 May 2013 | Classified by FDA | +150 days |
| 22 May 2013 | Published 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
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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|---|---|---|---|---|---|
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