Sunset Natural Products Recalls Lebytol Dietary Supplement Under Consent Decree
Sunset Natural Products Inc. is recalling Lebytol dietary supplements pursuant to a consent decree requiring the destruction of products manufactured or distributed since April 2, 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 rating under the rubric, particularly given the mandatory destruction of products under a consent decree.
Plain-English summary
Sunset Natural Products Inc. is recalling Lebytol, 30 capsules per bottle, pursuant to a consent decree with the U.S. Food and Drug Administration. The recall covers 2,400 bottles (72,000 capsules) distributed to Florida, Nevada, and the Dominican Republic. Specific lot numbers and expiration dates are listed in the agency's structured data, including lots expiring in 2017 and 2018.
The recall is mandated by a consent decree that 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 decree also requires the firm to hire a cGMP expert and receive written permission from the FDA to resume operations.
Consumers who have purchased Lebytol from Sunset Natural Products Inc. should stop using the product and follow the instructions provided by the recalling firm or the FDA for disposal or return, as the products must be destroyed under FDA supervision.
The recalled product
- Product
- Lebytol, 30 capsules per bottle
- 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 (15)
- 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 lots and expiration dates: Lot # 210714 Exp. Date 07/17
- Lot # 041214 Exp. Date 07/17
- Lot # 030315 Exp. Date 03/18
- Lot # 051114 Exp. Date 11/17
- Lot # 301214 Exp. Date 12/17
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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