Sunset Natural Products Recalls Dygeszyme Dietary Supplement Under Consent Decree
Sunset Natural Products Inc. is recalling Dygeszyme 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, 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 action and potential non-compliance.
Plain-English summary
Sunset Natural Products Inc. is recalling Dygeszyme, a dietary supplement, 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 or distributed since April 2, 2014, hire a cGMP expert, and receive written permission from the FDA to resume operations.
The recall covers 150,000 capsules of Dygeszyme (50,000 capsule bulk). The products were distributed to Florida, Nevada, and the Dominican Republic. Known lots include Lot # 630514 (Exp. 05/17), Lot # 050614 (Exp. 06/17), and Lot # 100315 (Exp. 04/18).
Consumers who have purchased this product should stop using it and follow the instructions provided by the recalling firm or the FDA regarding disposal or return.
The recalled product
- Product
- Dygeszyme, (50,000 capsule bulk)
- Manufacturer
- Sunset Natural Products Inc.
- Category
- Food — Dietary Supplement
- Affected units
- 150,000
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 (13)
- 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 # 630514 Exp. Date 05/17
- Lot # 050614 Exp. Date 06/17
- Lot # 100315 Exp. Date 04/18
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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