The Recall Desk
ModerateFDA (Food)·F-1203-2016·Announced 2016-05-11

Iowa Select Herbs Recalls Alcohol-Free Papaya Leaf for Misbranding

Iowa Select Herbs LLC is recalling Alcohol-Free Papaya Leaf products because they are misbranded, unapproved new drugs, and adulterated dietary supplements.

What this means for you

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 hazard involves regulatory violations (misbranding and adulteration) rather than a specific acute physical injury risk like choking or fire.

Plain-English summary

Iowa Select Herbs LLC is recalling Alcohol-Free Papaya Leaf products in various sizes, including 2, 4, 12, 16, 32, and 128 fluid ounces, as well as unknown sizes. The recalled products are identified by Lot 52972 and have an expiration date of 04/20.

The recall is being conducted pursuant to a consent decree for injunctive relief. The FDA determined that the products are misbranded, unapproved new drugs, and adulterated dietary supplements.

The recalled product was distributed to retail stores in California, Florida, Georgia, Iowa, Michigan, Missouri, Montana, New York, and South Carolina. It was also distributed to consumers nationwide and internationally in Denmark, Canada, the UK, Australia, and Serbia. Consumers should stop using the product and contact the manufacturer for instructions on return or disposal.

The recalled product

Product
Iowa Select Herbs LLC, Alcohol-Free, Papaya Leaf, www.iowaselectherbs.com, (a) 2 fl. Oz. (b) 4 fl. Oz. (c) 12 fl. Oz. (d) 16 fl. Oz. (e) 32 fl. Oz. (f) 128 fl. Oz. (g) unknown size, Cedar Rapids, IA 52402

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 - 52972
  • Expires 04/20

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 →