Iowa Select Herbs Recalls Psoralea Seed for Misbranding and Adulteration
Iowa Select Herbs LLC is recalling Psoralea Seed under a consent decree 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 classified this as an FDA Class III recall, 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 Psoralea Seed (Psoralea corylifolia), 1 gallon, manufactured in Cedar Rapids, Iowa. The recall is being conducted pursuant to a consent decree for injunctive relief. The specific lot affected is Lot-49697 with an expiration date of 02/2019.
The FDA determined that the recalled products are misbranded, unapproved new drugs, and adulterated dietary supplements. The agency's classification for this recall is Class III.
The product was distributed to retail stores in California, Florida, Georgia, Iowa, Michigan, Missouri, Montana, New York, and South Carolina. It was also sold to consumers nationwide and internationally in Denmark, Canada, the United Kingdom, Australia, and Serbia. Consumers should stop using the product and follow the instructions provided by the recalling firm or the FDA.
The recalled product
- Product
- Iowa Select Herbs LLC, Psoralea Seed (Psoralea corylifolia), 1 gallon, www.iowaselectherbs.com, 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 (1)
- Lot-49697 Exp - 02/2019
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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