Prolifta Dietary Supplement Recalled for Unapproved Erectile Dysfunction Ingredients
Haute Health, LLC is recalling Prolifta dietary supplements because they may contain unapproved active ingredients used in erectile dysfunction drugs.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classification is FDA Class I, which mandates a minimum severity score of 4 according to the rubric.
Plain-English summary
Haute Health, LLC is voluntarily recalling Prolifta Dietary Supplement, 400mg/capsule, in 1 and 2 capsule blister packs and 4, 12, and 24 capsule bottles. The recall involves 172,800 capsules distributed nationwide and internationally via internet sales. All lot codes and expiration dates are affected.
The FDA is recalling the product because it was marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA). The dietary supplement may contain amounts of an active ingredient found in some FDA-approved drugs for erectile dysfunction (ED), which makes the product an unapproved drug.
Consumers who have purchased Prolifta should stop using the product and contact Haute Health, LLC or Prolifta LLC at 1+877.239.8231 or visit www.proliftaherbal.com for further information.
The recalled 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.
- Manufacturer
- Haute Health, LLC
- Category
- Drug — Dietary Supplement
- Affected units
- 172,800
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- All lot codes and expiration dates.
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 3 recalled by Haute Health, LLC under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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