The Recall Desk
Agency classClass IIIOur severity:LowFDA (Food)·F-1224-2016·Announced 2016-05-11

Iowa Select Herbs Recalls Solomon Seal Supplements for Misbranding

Iowa Select Herbs LLC is recalling Solomon Seal dietary supplements because they are misbranded, unapproved new drugs, and adulterated.

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 1/5 (Low).

Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.

Our severity reasoning: The agency classified this as an FDA Class III recall, which is defined as unlikely to cause adverse health consequences. The source text does not report any illnesses or injuries.

Plain-English summary

Iowa Select Herbs LLC is recalling 1-gallon bottles of Solomon Seal dietary supplements. 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 initiated pursuant to a consent decree for injunctive relief. The firm was ordered to recall the products because they are misbranded, unapproved new drugs, and adulterated dietary supplements. The affected lots are Lot-350150980313 and Lot-32862, both with an expiration date of 02/2019.

Consumers who have purchased this product should stop using it and contact the manufacturer for further instructions.

The recalled product

Product
Iowa Select Herbs LLC, Solomon Seal, www.iowaselectherbs.com, 1 gallon, Cedar Rapids, IA 52402
Manufacturer
Iowa Select Herbs LLC
Category
Food — Dietary Supplement
Hazard
Affected units
3

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-350150980313 Expires-02/2019
  • Lot-32862 Expires-02/2019

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 →

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