Iowa Select Herbs Recalls Pygeum Bark Due to Misbranding and Adulteration
Iowa Select Herbs LLC is recalling Pygeum Bark products 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 agency classification is FDA Class III, which indicates the product is unlikely to cause adverse health consequences. The recall is driven by regulatory violations (misbranding/adulteration) rather than reported acute injuries or high-risk pathogens.
Plain-English summary
Iowa Select Herbs LLC is recalling Pygeum Bark products, including 4 fl oz bottles and unknown sizes, manufactured in Cedar Rapids, Iowa. The recall is being conducted pursuant to a consent decree for injunctive relief.
The FDA has determined that the recalled products are misbranded, unapproved new drugs, and adulterated dietary supplements. The specific lot number is Lot-32407 with an expiration date of 12/2019.
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 should stop using the product and contact the recalling firm for instructions.
The recalled product
- Product
- Iowa Select Herbs LLC, Pygeum Bark, www.iowaselectherbs.com, (a) 4 fl Oz. (b) unknown size, Cedar Rapids, IA 52402
- Manufacturer
- Iowa Select Herbs LLC
- Category
- Food — Dietary Supplement
- Hazard
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-32407 Exp - 12/2019
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.
See all 104 products in this recall →Related recalls
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