Sunset Natural Products Recalls Healthy Male Dietary Supplement Under Consent Decree
Sunset Natural Products Inc. is recalling Healthy Male 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 rating under the rubric, particularly given the mandatory destruction of products under a consent decree.
Plain-English summary
Sunset Natural Products Inc. is recalling Healthy Male, 60 capsules per bottle, 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 the decree was entered on September 25, 2015. The company must also hire a cGMP expert and receive written permission from the FDA to resume operations.
The recall involves 816 bottles, containing a total of 49,000 capsules. The affected lots include Lot # 220714 (Expiration Date 07/17), Lot # 190115 (Expiration Date 01/18), and Lot # 320615 (Expiration Date 06/18). The 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 by the recalling firm or the FDA regarding the destruction of the supplements.
The recalled product
- Product
- Healthy Male, 60 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 (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 # 220714 Exp. Date 07/17
- Lot # 190115 Exp. Date 01/18
- Lot # 320615 Exp. Date 06/18
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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