Sunset Natural Products Inc. recalls all Oyster Dietary Supplements manufactured from April 2, 2014, due to a consent decree with FDA requiring destruction. This recall follows a legal order to stop marketing supplements until compliance is achieved.
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 is recalling all Oyster Dietary Supplements made from April 2, 2014, because the company violated FDA regulations. This recall is part of a legal agreement requiring the company to destroy all affected products under FDA supervision.
The hazard comes from a legal violation where the company failed to follow FDA regulations for dietary supplements. This led to a consent decree that requires the company to stop marketing products until they meet FDA standards and destroy all affected items.
Anyone who owns or used Sunset Natural Products' Oyster Dietary Supplements made between April 2, 2014, and September 25, 2015. People who bought these supplements after the recall was issued are not affected.
Check for the product name 'Oyster Dietary Supplement' with an unknown container size. The recall covers all units manufactured from April 2, 2014, up to September 25, 2015, identified by lot number 440914.
Identify the product by checking for the lot number 440914 on the container.
Under FDA supervision, destroy all recalled Oyster Dietary Supplements to comply with the consent decree.
The company violated FDA regulations and must destroy all products made from April 2, 2014, as part of a consent decree to stop marketing supplements until they meet FDA standards.
Destroy the product under FDA supervision as required by the consent decree. Check for the lot number 440914 to confirm it's affected.
No, the product is not safe to use because the company violated FDA regulations and must be destroyed under 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-1033-2017 — Sunset Natural Products Sunset Natural Products Hello, I own a Sunset Natural Products that is covered by recall F-1033-2017 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.
