Prolifta Dietary Supplement Prolifta — Class I drug recall D-1235-2014
Terminated recall by Haute Health, LLC, reported 2014-04-23, distributed nationwide. Marketed without an Approved NDA/ANDA: Dietary supplement may contain amounts of an active ingredient found in
| Recall number | D-1235-2014 |
|---|---|
| Product type | Drug |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Haute Health, LLC, Williamstown, NJ, United States |
| Recall initiated | 2013-09-27 |
| Classified | 2014-04-15 |
| Reported by FDA | 2014-04-23 |
| Terminated | 2015-01-29 |
| Distributed | Nationwide (US) |
| Quantity | 172,800 capsules |
| Reason classes | unapproved product |
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-1235-2014. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.