The Recall Desk
Agency classClass IIOur severity:SevereFDA (Food)·F-1972-2018·Announced 2018-10-03

Men's Health Supplement Recalled for Undeclared Ingredients

Confidence Inc. is recalling For-Men-10 dietary supplements because they contain undeclared ingredients, including HPMC and artificial colors.

The agency’s classification

FDA (Food): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The agency classified this recall as FDA Class II. Per the rubric, FDA Class II recalls are assigned a severity score of 4 (Severe), particularly when no specific hospitalization reports are cited to lower the score to a different tier, and the classification itself mandates a minimum of 4.

Plain-English summary

Confidence Inc./Confidence U.S.A. Inc. is recalling 2,016 bottles of FP0392, For-Men-10, All Natural Formula to Overall Men's Health, a dietary supplement containing 60 tablets. The product is identified by Lot # 020116 and UPC 8 92483 00139 7.

The recall was initiated because the product contains undeclared ingredients. These include Hydroxypropyl Methylcellulose (HPMC), Titanium Dioxide, Polyethylene Glycol (PEG), Triacetin, FD&C Yellow #6 (Sunset Yellow FCF), FD&C Red #40 (Allura Red AC), and FD&C Blue #1 (Aluminum Lake). The agency has classified this recall as Class II.

The affected product was distributed in New York, Michigan, Tennessee, Florida, Illinois, Wisconsin, New Jersey, Maryland, Texas, California, Virginia, Louisiana, Mississippi, Washington, South Carolina, Ohio, Nevada, Nebraska, Pennsylvania, and Hawaii. Consumers should stop using the product and return it to the place of purchase for a refund.

The recalled product

Product
FP0392, For-Men-10, All Natural Formula to Overall Men's Health, A Dietary Supplement, 60 Tablets, UPC: 8 92483 00139 7
Manufacturer
Confidence Inc./Confidence U.S.A. Inc.
Category
Food — Dietary Supplement
Hazard
Affected units
2,016

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)

  • Lot# 020116

Distribution

Distributed in 20 states:

Part of a larger recall action

This product is one of 2 recalled by Confidence Inc./Confidence U.S.A. Inc. under a single FDA (Food) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

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