# FDA recall D-0959-2016

> **Reesna, Inc** · Class I · drug recall initiated 2015-12-11.

## Product

FUEL UP PLUS, capsules, a) 1-count package, b) 5-count bottle, c) 10-count bottle  WWW.FUELUPPILLS.COM

## 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.

## Distribution

Nationwide and United Kingdom

## Key facts

- **Recall number:** D-0959-2016
- **Recalling firm:** Reesna, Inc
- **Classification:** Class I
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2015-12-11
- **Report date:** 2016-06-15
- **Termination date:** 2016-06-09

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Canoga Park, CA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0959-2016

## Citation

> AI Analytics. FDA recall D-0959-2016. Retrieved 2026-05-26 from https://api.ai-analytics.org/recall/D-0959-2016. Source: US FDA. Licensed CC0.

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