Iowa Select Herbs Recalls Gymnema Sylvestre Supplements for Misbranding
Iowa Select Herbs LLC is recalling Gymnema Sylvestre supplements 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 the rubric indicates is typically a score of 1 or 2. The hazards involve regulatory violations (misbranding, adulteration) without reported illnesses or injuries, fitting the Moderate category for low-risk contamination or labeling issues.
Plain-English summary
Iowa Select Herbs LLC is recalling Gymnema Sylvestre (Gymnena sylvestre) dietary supplements in 2 fl. oz. and 4 fl. oz. bottles. The recall is being conducted pursuant to a consent decree for injunctive relief.
The recalled products are identified as misbranded, unapproved new drugs, and adulterated dietary supplements. The specific lot number is m10866, with an expiration date of 02/2019. The quantity involved is 12 bottles of the 2 fl. oz. size and 16 bottles of the 4 fl. oz. size.
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 follow instructions from the recalling firm or the FDA.
The recalled product
- Product
- Iowa Select Herbs LLC, Gymnema Sylvestre (Gymnena sylvestre), www.iowaselectherbs.com, (a) 2 fl. Oz. (b) 4 fl. Oz., 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 (2)
- Lot - m10866
- Expires - 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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