The Recall Desk
Agency classClass IIIOur severity:ModerateFDA (Food)·F-1226-2016·Announced 2016-05-11

Iowa Select Herbs Recalls Suma Root Due to Misbranding and Adulteration

Iowa Select Herbs LLC is recalling 1-gallon bottles of Suma Root because the product is misbranded, an unapproved new drug, and an adulterated dietary supplement.

The agency’s classification

FDA (Food): Class III

Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.

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 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The agency classification is FDA Class III, which is defined as unlikely to cause adverse health consequences. The recall is driven by regulatory violations (misbranding/adulteration) rather than reported acute physical harm.

Plain-English summary

Iowa Select Herbs LLC is recalling 3 bottles of Suma Root, 1 gallon size, manufactured in Cedar Rapids, IA. The product was distributed to retail stores in California, Florida, Georgia, Iowa, Michigan, Missouri, Montana, New York, and South Carolina, as well as to consumers nationwide and internationally in Denmark, Canada, the UK, Australia, and Serbia.

The recall is being conducted pursuant to a consent decree for injunctive relief. The firm was ordered to recall all products because they are misbranded, unapproved new drugs, and adulterated dietary supplements. The specific lot number is 21035, with an expiration date of 02/2019.

Consumers who have purchased this product should stop using it and contact the recalling firm for further instructions.

The recalled product

Product
Iowa Select Herbs LLC, Suma Root, www.iowaselectherbs.com, 1 gallon, Cedar Rapids, IA 52402
Manufacturer
Iowa Select Herbs LLC
Category
Food — Dietary Supplement
Hazard
Affected units
3

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-21035 Expires-02/2019

Distribution

Distributed nationwide across the United States.

The notice also names 9 states specifically:

Part of a larger recall action

This product is one of 104 recalled by Iowa Select Herbs LLC 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 104 products in this recall →

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