CLASS I Drug recall · Reported 30 Apr 2014 · FDA Enforcement Report
RezzRX capsules, Single Blister Pack recalled by Fossil Fuel Products
Fossil Fuel Products is recalling RezzRX capsules, Single Blister Pack, distributed nationwide in the US. The recall was initiated on 18 Nov 2013 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-1248-2014
- FDA event ID
- 66878
- Recalling firm
- Fossil Fuel Products, Dallas, GA
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- 18 Nov 2013
- FDA classified
- 18 Apr 2014
- Reported
- 30 Apr 2014
- Type
- Voluntary: Firm initiated
- Customers notified by
- Press Release
- Reason category
- Labeling Errors
Timeline
| 18 Nov 2013 | Recall initiated by company | |
| 18 Apr 2014 | Classified by FDA | +151 days |
| 30 Apr 2014 | Published in enforcement report | +12 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: Fossil Fuel Products, is recalling RezzRX due to undeclared hydroxylthiohomosildenafil and aminotadalafil.
Product as listed by the FDA
RezzRX capsules, Single Blister Pack and 20 count bottle, Distributed By: Fossil Fuel Products, LLC Atlanta, GA 30309
Where it was distributed
Nationwide.
Questions about this recall
Why was it recalled?
Marketed Without an Approved NDA/ANDA: Fossil Fuel Products, is recalling RezzRX due to undeclared hydroxylthiohomosildenafil and aminotadalafil.
Which lots are affected?
Lots QL110408B046, QL110714A102 Exp. 11/13
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 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.