Iowa Select Herbs Recalls Papaya Leaf Products for Misbranding and Adulteration
Iowa Select Herbs LLC is recalling Papaya 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 indicates the product is unlikely to cause adverse health consequences. The hazards are regulatory (misbranding, unapproved new drug, adulteration) rather than acute physical injury risks.
Plain-English summary
Iowa Select Herbs LLC is recalling various sizes of Papaya Leaf (Carica papaya) products. The recall was initiated pursuant to a consent decree for injunctive relief, which ordered the firm to recall all products.
The products are being recalled because they are misbranded, unapproved new drugs, and adulterated dietary supplements. The recalled items were 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 who have purchased these products should stop using them and contact the recalling firm for further instructions. The specific lot numbers and expiration dates associated with the recall are R1380ST (Expires 04/2020) and 52972 (Expires 04/2020).
The recalled product
- Product
- Iowa Select Herbs LLC, Papaya Leaf (Carica papaya), www.iowaselectherbs.com, (a) 2 fl. Oz. (b) 4 fl. Oz. (c) 16 fl. Oz. (d) 32 fl. Oz. (e) 32 & 16 fl. Oz. (f) 128 fl. Oz. (g) 164 fl. Oz. (h) unknown size, Cedar Rapids, IA 52402
- Manufacturer
- Iowa Select Herbs LLC
- Category
- Food — Dietary Supplement
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 (4)
- Lot - R1380ST
- Expires - 04/2020
- Lot - 52972
- 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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