The Recall Desk
Agency classClass IIIOur severity:ModerateFDA (Food)·F-1163-2016·Announced 2016-05-11

Iowa Select Herbs Recalls Cold Be Gone for Misbranding and Adulteration

Iowa Select Herbs LLC is recalling Cold Be Gone products 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 issues are regulatory (misbranding, unapproved new drug status, adulteration) rather than acute physical hazards like choking or fire.

Plain-English summary

Iowa Select Herbs LLC is recalling Cold Be Gone products in various sizes, including 1/2 fl. Oz., 15 ml, 1 fl. Oz., and 30 ml bottles. The recalled items are identified by Lot 87366 and have an expiration date of 01/2020. The company is based in Cedar Rapids, Iowa.

The recall was initiated 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 quantities involved are 108 bottles of 1/2 fl. Oz., 6 bottles of 15 ml, 184 bottles of 1 fl. Oz., 1 bottle of 30 ml, and 1 bottle of unknown size.

The products were distributed to retail stores in California, Florida, Georgia, Iowa, Michigan, Missouri, Montana, New York, and South Carolina. They were also sold to consumers nationwide and internationally in Denmark, Canada, the UK, Australia, and Serbia. Consumers should stop using the product and follow instructions from the recalling firm or the FDA.

The recalled product

Product
Iowa Select Herbs LLC, Cold Be Gone, www.iowaselectherbs.com, (a) 1/2 fl. Oz., (b) 15 ml, (c) 1 fl. Oz., (d) 30 ml (e) unknown size, Cedar Rapids, IA 52402
Manufacturer
Iowa Select Herbs LLC
Category
Drug — Dietary Supplement
Hazard

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 - 87366
  • Expires - 01/2020

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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