The Recall Desk
ModerateFDA (Food)·F-1148-2016·Announced 2016-05-11

Iowa Select Herbs Recalls Black Cohosh Root for Misbranding and Adulteration

Iowa Select Herbs LLC is recalling Black Cohosh Root under a consent decree because the product is misbranded, an unapproved new drug, and an adulterated dietary supplement.

What this means for you

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 recall is classified as FDA Class III, which the rubric indicates is typically a score of 1 or 2. The hazard involves regulatory violations (misbranding/adulteration) without reported injuries, fitting the Moderate category for low-risk or voluntary/precautionary issues.

Plain-English summary

Iowa Select Herbs LLC is recalling 2 bottles of Black Cohosh Root (1 fl. Oz.) under a consent decree for injunctive relief. The product is identified by Lot 19972 and has an expiration date of 08/2019.

The recall was ordered because the product is misbranded, an unapproved new drug, and an adulterated dietary supplement. The recalled 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.

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, Black Cohosh Root, www.iowaselectherbs.com, 1 fl. Oz., Cedar Rapids, IA 52402
Affected units
2

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 (2)

  • Lot - 19972
  • Expires - 08/2019

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 →