Sunset Natural Products recalls Hepasil dietary supplements produced since April 2014 due to FDA consent decree requirements. Consumers should stop using and destroy affected lots.
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 manufatured or distributed since April 2, 2014, hire a cGMP expert and receive written permission from FDA to resume operations.
Sunset Natural Products is recalling Hepasil dietary supplements produced since April 2014. This recall follows a consent decree with the FDA that requires the company to destroy these products before resuming operations.
The hazard stems from a consent decree with the FDA that prohibits the company from marketing dietary supplements until they destroy products made since April 2014 and meet other regulatory requirements. The recall is a legal requirement to prevent future violations.
Anyone who purchased Hepasil dietary supplements in bulk of 500,000 capsules from Sunset Natural Products. Consumers most at risk are those who have used products made since April 2014.
Check for Hepasil dietary supplements in bulk of 500,000 capsules with lot number 080315 and expiration date 03/18. Products made since April 2014 are affected.
Immediately stop using Hepasil dietary supplements produced since April 2014.
Sunset Natural Products must destroy Hepasil supplements made since April 2014 as part of a consent decree with the FDA to comply with regulatory requirements.
Check for Hepasil dietary supplements in bulk of 500,000 capsules with lot number 080315 and expiration date 03/18.
Destroy the Hepasil supplements produced since April 2014 as required by the consent decree.
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-0617-2016 — Sunset Natural Products Sunset Natural Products Hello, I own a Sunset Natural Products that is covered by recall F-0617-2016 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.
