CLASS I Drug recall · Reported 15 Jun 2016 · FDA Enforcement Report
Fuel UP High Octane, capsules, a) package, b) recalled by Reesna
Reesna is recalling Fuel UP High Octane, capsules, a) package, b), c) bottle Www.Fueluppills.Com, distributed nationwide in the US. The recall was initiated on 11 Dec 2015 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-0960-2016
- FDA event ID
- 72830
- Recalling firm
- Reesna, Canoga Park, CA
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- 11 Dec 2015
- FDA classified
- 6 Jun 2016
- Reported
- 15 Jun 2016
- Type
- Voluntary: Firm initiated
- Customers notified by
- Telephone
- Reason category
- Labeling Errors
Timeline
| 11 Dec 2015 | Recall initiated by company | |
| 6 Jun 2016 | Classified by FDA | +178 days |
| 15 Jun 2016 | Published in enforcement report | +9 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: Tainted Product Marketed As a Dietary Supplement: Products were found to be tainted with undeclared hydroxythiohomosildenafil, an analogue of Sildenafil, an FDA-approved drug for the treatment of male Erectile Dysfunction (ED), making them unapproved new drugs.
Product as listed by the FDA
FUEL UP HIGH OCTANE, capsules, a) 1-count package, b) 5-count bottle, c) 10-count bottle WWW.FUELUPPILLS.COM
Where it was distributed
Nationwide and United Kingdom
Questions about this recall
Why was it recalled?
Marketed Without An Approved NDA/ANDA: Tainted Product Marketed As a Dietary Supplement: Products were found to be tainted with undeclared hydroxythiohomosildenafil, an analogue of Sildenafil, an FDA-approved drug for the treatment of male Erectile Dysfunction (ED), making them unapproved new drugs.
Which lots are affected?
Exp. 12/18
Where was it sold?
Nationwide and United Kingdom
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
1 other product · FDA event 72830This product is part of a recall event; the main page for the event is Fuel UP Plus, capsules, a) package, b) recalled by Reesna.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS I | Fuel UP Plus, capsules, a) package, b) recalled by Reesna | Reesna | Labeling Errors | Nationwide |
More recalls from Reesna
All 2| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS I | Fuel UP Plus, capsules, a) package, b) recalled by Reesna | Reesna | Labeling Errors | Nationwide |