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.
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 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
- Manufacturer
- Iowa Select Herbs LLC
- Category
- Food — Dietary Supplement
- Hazard
- 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
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.
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