Sunset Natural Products Recalls Ashwaganda Dietary Supplement Under Consent Decree
Sunset Natural Products Inc. is recalling Ashwaganda dietary supplements pursuant to a consent decree requiring the destruction of products manufactured or distributed since April 2014.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classification is FDA Class II, and the recall is mandated by a consent decree requiring the destruction of all products manufactured since 2014, which aligns with the 'Severe' criteria for significant regulatory intervention and potential risk.
Plain-English summary
Sunset Natural Products Inc. is recalling Ashwaganda dietary supplements of unknown container size. This action is being taken pursuant to a consent decree entered on September 25, 2015, which prohibits the company and its owners from marketing dietary supplements until specific corrective actions are completed.
The consent decree requires the firm to recall and destroy, under FDA supervision, all dietary supplements manufactured, prepared, processed, packed, labeled, held, and/or distributed between April 2, 2014, and the date of the decree's entry. The firm must also hire a cGMP expert and receive written permission from the FDA to resume operations. Known lot number 120215 is identified in the recall documentation.
Products were distributed to Florida, Nevada, and the Dominican Republic. Consumers who have purchased these products should stop using them and follow the instructions provided in the consent decree regarding the recall and destruction process.
The recalled product
- Product
- Ashwaganda 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 # 120215
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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