# FDA recall D-1235-2014

> **Haute Health, LLC** · Class I · drug recall initiated 2013-09-27.

## Product

Prolifta Dietary Supplement Prolifta, 400mg/capsule, Packaged in 1 and 2 capsule blister packs and 4, 12, and 24 capsule bottles   Made in the USA Distributed by: Prolifta LLC 1+877.239.8231  www.proliftaherbal.com.

## Reason for recall

Marketed without an Approved NDA/ANDA: Dietary supplement may contain amounts of an active ingredient found in some FDA-approved drugs for erectile dysfunction (ED) making the dietary supplement an unapproved drug.

## Distribution

Nationwide and internationally via internet sales.

## Key facts

- **Recall number:** D-1235-2014
- **Recalling firm:** Haute Health, LLC
- **Classification:** Class I
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2013-09-27
- **Report date:** 2014-04-23
- **Termination date:** 2015-01-29

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Williamstown, NJ, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1235-2014

## Citation

> AI Analytics. FDA recall D-1235-2014. Retrieved 2026-06-16 from https://api.ai-analytics.org/recall/D-1235-2014. Source: US FDA. Licensed CC0.

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