Sunset Natural Products Recalls Aloe Vera Dietary Supplements Under Consent Decree
Sunset Natural Products Inc. is recalling Aloe Vera dietary supplements pursuant to a consent decree requiring the destruction of products manufactured 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, which corresponds to a Severe severity score under the rubric, particularly given the mandatory destruction of products under a consent decree.
Plain-English summary
Sunset Natural Products Inc. is recalling Aloe Vera, 300 mg, Dietary Supplements. This action is taken pursuant to a consent decree that prohibits the company and its owners from marketing dietary supplements until specific conditions are met, including the recall and destruction of all dietary supplements 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 recall covers products distributed to Florida, Nevada, and the Dominican Republic. Known lot numbers include 150115, 160115, 350115, 340215, 400315, 340415, 070615, 420615, 430615, 030815, 240815, and 250815. The consent decree also requires the firm to hire a cGMP expert and receive written permission from the FDA to resume operations.
Consumers who have purchased these products should stop using them and follow the instructions provided by the recalling firm or the FDA regarding the destruction of the supplements.
The recalled product
- Product
- Aloe Vera, 300 mg, Dietary Supplement
- 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 (20)
- 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 # 150115
- 160115
- 350115
- 340215
- 400315
- 340415
- 070615
- 420615
- 430615
- 030815
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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