CLASS I Drug recall · Reported 28 May 2014 · FDA Enforcement Report
Boost Ultra, sexual enhancement dietary supplement recalled
Schindele Enterprises is recalling Boost Ultra, sexual enhancement dietary supplement, distributed in 13 states. The recall was initiated on 9 Jan 2014 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-1335-2014
- FDA event ID
- 67228
- Recalling firm
- Schindele Enterprises, Nixa, MO
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- 9 Jan 2014
- FDA classified
- 20 May 2014
- Reported
- 28 May 2014
- Type
- Voluntary: Firm initiated
- Customers notified by
- Press Release
- Reason category
- Labeling Errors
Timeline
| 9 Jan 2014 | Recall initiated by company | |
| 20 May 2014 | Classified by FDA | +131 days |
| 28 May 2014 | Published in enforcement report | +8 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: These dietary supplements contain undeclared sildenafil, an analogue of sildenafil, and/or tadalafil.
Product as listed by the FDA
BOOST ULTRA, sexual enhancement dietary supplement, 12-capsule/bottle. Also packaged in 3 pill bottles and 1 pill packs. BoostUtra.com, Springfield, MO.
Where it was distributed
Distributed to PA, IL, TX, IA, GA, CT, FL, CA, LA, NY, MD, NV, and WI
CaliforniaConnecticutFloridaGeorgiaIowaIllinoisLouisianaMarylandNevadaNew YorkPennsylvaniaTexasWisconsin
Questions about this recall
Why was it recalled?
Marketed Without an Approved NDA/ANDA: These dietary supplements contain undeclared sildenafil, an analogue of sildenafil, and/or tadalafil.
Which lots are affected?
12 pill bottle and 3 pill bottle: Lot # B70130 Exp. 03/15; 1 pill pack: Lot # 06012011 Exp 06/14.
Where was it sold?
Distributed to PA, IL, TX, IA, GA, CT, FL, CA, LA, NY, MD, NV, and WI
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 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
6 other products · FDA event 67228This product is part of a recall event; the main page for the event is Sexy Monkey, 2000 mg blister recalled by Schindele Enterprises.
More recalls from Schindele Enterprises
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|---|---|---|---|---|---|
| Drug | CLASS I | MiracleZEN Platinum, 1 pill recalled by Schindele Enterprises | Schindele Enterprises | Labeling Errors | 13 states |
| Drug | CLASS I | Magic For Men recalled by Schindele Enterprises | Schindele Enterprises | Labeling Errors | 13 states |
| Drug | CLASS I | Xzen Platinum, 750 mg recalled by Schindele Enterprises | Schindele Enterprises | Labeling Errors | 13 states |
| Drug | CLASS I | ExtenZe 600 mg recalled by Schindele Enterprises | Schindele Enterprises | Labeling Errors | 13 states |
| Drug | CLASS I | Xzone Gold blister 750 mg recalled by Schindele Enterprises | Schindele Enterprises | Labeling Errors | 13 states |