Iowa Select Herbs Recalls Lobelia Leaf Due to Misbranding and Adulteration
Iowa Select Herbs LLC is recalling Lobelia Leaf products under a consent decree because they are misbranded, unapproved new drugs, and adulterated dietary supplements.
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 typically corresponds to a score of 1 or 2. A score of 2 is assigned due to the legal basis of the recall (consent decree) and the nature of the violation (unapproved new drugs/adulteration), which exceeds a simple cosmetic or documentation error.
Plain-English summary
Iowa Select Herbs LLC is recalling Lobelia Leaf (Lobelia inflata), 1 fl. Oz. bottles, manufactured in Cedar Rapids, IA. The recall is being conducted pursuant to a consent decree for injunctive relief. The specific lot number is 31266, with an expiration date of 06/2019.
The FDA determined that the recalled products are misbranded, unapproved new drugs, and adulterated dietary supplements. The agency classified this recall as Class III, which indicates that use of or exposure to the violative product is not likely to cause adverse health consequences.
The recalled product was distributed to retail stores in California, Florida, Georgia, Iowa, Michigan, Missouri, Montana, New York, and South Carolina. It was also distributed to consumers nationwide and internationally in Denmark, Canada, the UK, Australia, and Serbia. Consumers should stop using the product and contact the recalling firm for instructions on how to return it.
The recalled product
- Product
- Iowa Select Herbs LLC, Lobelia Leaf, (Lobelia inflata) www.iowaselectherbs.com, 1 fl. Oz., Cedar Rapids, IA 52402
- Manufacturer
- Iowa Select Herbs LLC
- Category
- Food — Dietary Supplement
- Hazard
- Affected units
- 1
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 - 31266
- Expires - 06/2019
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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