The Recall Desk
ModerateFDA (Food)·F-1141-2016·Announced 2016-05-11

Iowa Select Herbs Recalls Ashwaganda Root Due to Misbranding and Adulteration

Iowa Select Herbs LLC is recalling Ashwaganda Root 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 agency classification is Class III, which the rubric defines as typically resulting in a score of 1 or 2 because it is unlikely to cause adverse health consequences. The recall is driven by regulatory violations (misbranding/adulteration) rather than reported acute injuries.

Plain-English summary

Iowa Select Herbs LLC is recalling specific bottles of Ashwaganda Root (Withania somnifera) in 1 fl. Oz. and 4 fl. Oz. (120 ml) sizes. The recalled products are identified by Lot 22349 and have an expiration date of 05/2019.

The recall was initiated pursuant to a consent decree for injunctive relief, which ordered the firm to recall all products because they 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, as well as to consumers nationwide and internationally in Denmark, Canada, the UK, Australia, and Serbia. Consumers should stop using the product and contact the recalling firm for further instructions.

The recalled product

Product
Iowa Select Herbs LLC, Ashwaganda Root (Withania somnifera), www.iowaselectherbs.com, (a) 1 fl. Oz. and (b) 4 fl. Oz. (120 ml), 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 - 22349
  • Expires - 05/2019

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 →