The Recall Desk
ModerateFDA (Food)·F-1167-2016·Announced 2016-05-11

Iowa Select Herbs Recalls Damiana Leaf Due to Misbranding and Adulteration

Iowa Select Herbs LLC is recalling Damiana Leaf 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 indicates the product is unlikely to cause adverse health consequences, fitting the criteria for a moderate severity score involving labeling or regulatory violations without reported acute harm.

Plain-English summary

Iowa Select Herbs LLC is recalling Damiana Leaf (Turnera diffusa), 1 gallon bottles, manufactured in Cedar Rapids, Iowa. The recall is being conducted pursuant to a consent decree for injunctive relief.

The FDA determined that the recalled products are misbranded, unapproved new drugs, and adulterated dietary supplements. The specific lot number is 31265, with an expiration date of 04/2017.

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. Consumers should stop using the product and contact the firm for instructions on disposal or return.

The recalled product

Product
Iowa Select Herbs LLC, Damiana Leaf (Turnera diffusa), www.iowaselectherbs.com, 1 gallon, 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 - 31265
  • Expires - 04/2017

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 →