Sunset Natural Products Recalls Libene Dietary Supplement Under Consent Decree
Sunset Natural Products Inc. is recalling Libene Dietary Supplement pursuant to a consent decree requiring the destruction of products manufactured or distributed 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 and is a voluntary precautionary action mandated by a consent decree to ensure compliance with cGMP standards. The source text does not report any illnesses, injuries, or specific high-risk pathogens, fitting the criteria for a moderate severity score.
Plain-English summary
Sunset Natural Products Inc. is recalling Libene Dietary Supplement (unknown container size) pursuant to a consent decree with the U.S. Food and Drug Administration. The decree prohibits the company and its owners from marketing dietary supplements until they recall and destroy all products manufactured, prepared, processed, packed, labeled, held, and/or distributed between April 2, 2014, and the date of the decree's entry on September 25, 2015. The firm is also required to hire a cGMP expert and receive written permission from the FDA to resume operations.
The recall covers products distributed to Florida, Nevada, and the Dominican Republic. A known lot number is 160615. The source text does not specify the quantity of units recalled or report any illnesses or injuries associated with the product.
Consumers who have purchased Libene Dietary Supplement should stop using the product and follow the instructions provided by the recalling firm or the FDA regarding disposal or return, as the product is subject to destruction under FDA supervision.
The recalled product
- Product
- Libene Dietary Supplement (unknown container size)
- Manufacturer
- Sunset Natural Products Inc.
- Category
- Food — Dietary Supplement
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 # 160615
Distribution
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.
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