The Recall Desk
ModerateFDA (Food)·F-1035-2017·Announced 2017-01-04

Sunset Natural Products Recalls LOISIM Dietary Supplement Under Consent Decree

Sunset Natural Products Inc. is recalling LOISIM Dietary Supplement pursuant to a consent decree requiring the destruction of products manufactured since April 2014.

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 II, which typically involves a situation where use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences. The source does not report specific injuries or illnesses, and the action is driven by a consent decree rather than a specific reported safety incident.

Plain-English summary

Sunset Natural Products Inc. is recalling LOISIM Dietary Supplement of unknown container size. This action is being taken pursuant to a consent decree that prohibits the company and its owners from marketing dietary supplements until specific conditions are met. The decree requires the firm to recall and destroy all dietary supplements manufactured, prepared, processed, packed, labeled, held, and/or distributed between April 2, 2014, and the date the decree was entered on September 25, 2015. The recall is conducted under FDA supervision.

The consent decree also requires the company to hire a cGMP expert and receive written permission from the FDA to resume operations. The source text does not specify a particular health hazard, such as contamination or mislabeling, associated with this specific recall action, but rather cites the legal requirement to destroy products manufactured during the specified period.

Products were distributed to Florida, Nevada, and the Dominican Republic. The known lot number is 111114. Consumers who possess this product should stop using it and follow the instructions provided by the recalling firm or the FDA regarding disposal or return, as the products are subject to destruction under the decree.

The recalled product

Product
LOISIM Dietary Supplement (unknown container size)
Manufacturer
Sunset Natural Products Inc.
Category
Food — 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 (11)

  • As persuant to the Consent Decree
  • the firm agreed to "recall and destroy
  • under FDA's supervision
  • in accordance with the procedures provided in paragraph 6
  • ALL dietary supplements that were manufactured
  • prepared
  • processed
  • packed
  • labeled
  • held and/or distributed between April 2
  • 2015. Known lot: Lot # 111114

Distribution

Distributed in 2 states:

Part of a larger recall action

This product is one of 163 recalled by Sunset Natural Products Inc. 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 163 products in this recall →

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