Iowa Select Herbs Recalls Milk Thistle Supplement for Misbranding
Iowa Select Herbs LLC is recalling 12 bottles of Alcohol Free Milk Thistle 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 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The agency classification is FDA Class III, which the rubric defines as typically resulting in a score of 1 or 2 because it is unlikely to cause adverse health consequences.
Plain-English summary
Iowa Select Herbs LLC is recalling 12 bottles of Alcohol Free Milk Thistle, 16 fl. Oz. The recalled product is identified by Lot 32358 and has an expiration date of 04/2020. 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.
The recall is being conducted pursuant to a consent decree for injunctive relief. The firm was ordered to recall all products because they are misbranded, unapproved new drugs, and adulterated dietary supplements.
Consumers who purchased this product should stop using it and contact the recalling firm for further instructions.
The recalled product
- Product
- Iowa Select Herbs LLC, Alcohol Free, Milk Thistle, www.iowaselectherbs.com, 16 fl. Oz., Cedar Rapids, IA 52402
- Manufacturer
- Iowa Select Herbs LLC
- Category
- Food — Dietary Supplement
- Hazard
- Affected units
- 12
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 - 32358
- Expires - 04/2020
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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