Sunset Natural Products recalls bulk Argindione capsules manufactured since April 2014 due to FDA compliance requirements. Consumers should not use these supplements until the company resolves its regulatory issues.
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 bulk Argindione capsules sold in quantities of 50,000 capsules. This recall is required by a consent decree that prohibits the company from marketing dietary supplements until they fix regulatory compliance issues with the FDA.
The company has been prohibited from marketing dietary supplements by a consent decree with the FDA until they address regulatory compliance. This recall is part of the company's obligation to stop selling supplements until they meet FDA requirements.
Anyone who purchased Argindione capsules from Sunset Natural Products since April 2, 2014. People using these supplements are at risk of continued regulatory violations until the company resolves its FDA compliance issues.
Check for Argindione capsules sold in bulk quantities of 50,000 capsules. Lot numbers 480514 (expiring May 17) and 320614 (expiring June 17) are included in this recall.
Identify if your capsules have lot numbers 480514 or 320614 with expiration dates of May 17 or June 17.
Sunset Natural Products must recall these capsules as part of a consent decree with the FDA that prohibits them from marketing dietary supplements until they resolve regulatory compliance issues.
The recall record does not specify a remedy, so no action is required beyond checking if your capsules are in the recalled lots.
The recall was issued for capsules manufactured or distributed since April 2, 2014, but the exact recall date is not stated in the record.
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-0537-2016 — Sunset Natural Products Sunset Natural Products Hello, I own a Sunset Natural Products that is covered by recall F-0537-2016 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.
