Sunset Natural Products Inc. recalls Hidroxol dietary supplements manufactured from April 2, 2014, due to a consent decree with FDA. All affected lots must be destroyed under FDA supervision.
Pursuant to a consent decree that prohibits the company and its owners for marketing dietary supplements until they, among other things, recall and destroy the dietary supplements that have been manufactured or distributed since April 2, 2014, hire a cGMP expert and receive written permission from FDA to resume operations.
Sunset Natural Products Inc. is recalling all Hidroxol dietary supplements made from April 2, 2014, because the company violated FDA regulations. This recall is part of a consent decree requiring the company to destroy all affected products under FDA supervision.
The hazard comes from the company's violation of FDA regulations, which led to a consent decree requiring the destruction of all affected products. This is not a safety risk but a legal compliance issue under the FDA's oversight.
Anyone who purchased Hidroxol dietary supplements between April 2, 2014, and September 25, 2015, from Sunset Natural Products Inc. is affected. The risk is low as the recall is a regulatory compliance action, not a safety hazard.
Check the product label for lot numbers: 410614, 020814, 150914, 260914, 181214, 210115, 330115, 150215, 540315, 200415, 530615, or 010715. The product was manufactured between April 2, 2014, and September 25, 2015.
Look for lot numbers on the label: 410614, 020814, 150914, 260914, 181214, 210115, 330115, 150215, 540315, 200415, 530615, or 010715.
If the product is affected, destroy it following FDA's procedures for recall destruction.
Sunset Natural Products Inc. violated FDA regulations, leading to a consent decree that requires the destruction of all affected products.
Affected lot numbers include: 410614, 020814, 150914, 260914, 181214, 210115, 330115, 150215, 540315, 200415, 530615, and 010715.
The recall was issued on September 25, 2015, as part of a consent decree entered that date.
We’ve drafted a message you can send Sunset Natural Products to request your refund or repair — edit it as you like.
Subject: Recall F-1029-2017 — Sunset Natural Products Sunset Natural Products Hello, I own a Sunset Natural Products that is covered by recall F-1029-2017 from Sunset Natural Products. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.