The Recall Desk
Agency classClass IIIOur severity:ModerateFDA (Food)·F-1207-2016·Announced 2016-05-11

Iowa Select Herbs Recalls Organic Papaya Leaf Capsules for Misbranding

Iowa Select Herbs LLC is recalling Organic Papaya Leaf capsules 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 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, adulteration) rather than acute physical injury risks.

Plain-English summary

Iowa Select Herbs LLC is recalling 36 bottles of Organic Papaya Leaf (paw paw/papain), 500 mg, 60 Capsules. The recall was initiated pursuant to a consent decree for injunctive relief, which ordered the firm to recall all products.

The recalled product is being recalled because it is misbranded, an unapproved new drug, and an adulterated dietary supplement. 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 who have purchased this product should stop using it and contact the recalling firm for further instructions.

The recalled product

Product
Iowa Select Herbs LLC, Organic Papaya Leaf (paw paw/papain), 500 mg, 60 Capsules, www.iowaselectherbs.com, Cedar Rapids, IA 52402
Manufacturer
Iowa Select Herbs LLC
Category
Food — Dietary Supplement
Hazard
Affected units
36

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)

  • Unknown

Distribution

Distributed nationwide across the United States.

The notice also names 9 states specifically:

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 →

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