The Recall Desk
ModerateFDA (Food)·F-1220-2016·Announced 2016-05-11

Iowa Select Herbs Recalls Sassafras Root Bark Due to Misbranding

Iowa Select Herbs LLC is recalling Sassafras Root Bark because it is misbranded, an unapproved new drug, and an adulterated dietary supplement.

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 issues are regulatory (misbranding and adulteration) rather than acute physical hazards like choking or fire.

Plain-English summary

Iowa Select Herbs LLC is recalling Sassafras Root Bark (Smilax uti lis), 7.5 fl. Oz. bottles. 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.

The recall was ordered pursuant to a consent decree for injunctive relief. The FDA determined that the products are misbranded, unapproved new drugs, and adulterated dietary supplements. The specific lot number is 30709, with an expiration date of 07/2019.

Consumers who have purchased this product should stop using it and return it to the place of purchase for a refund or contact the recalling firm for further instructions.

The recalled product

Product
Iowa Select Herbs LLC, Sassparilla Smilax uti lis, www.iowaselectherbs.com, 7.5 fl. Oz.., Cedar Rapids, IA 52402
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-30709 Expires-07/2019

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 →