Sunset Natural Products recalls Bioxtron dietary supplements manufactured from April 2, 2014, due to a consent decree with FDA requiring destruction of all products. Affected lots listed in the recall notice.
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 Bioxtron dietary supplements made from April 2, 2014, because the company violated FDA regulations. This recall is part of a consent decree that requires them to destroy all products and hire a cGMP expert before resuming operations.
The company violated FDA regulations by marketing dietary supplements without proper compliance. This led to a consent decree requiring them to recall and destroy all products made since April 2014 before they can resume operations.
Anyone who purchased Bioxtron dietary supplements between April 2, 2014, and September 25, 2015, is affected. Consumers who have the listed lot numbers are at risk of needing to destroy the products.
Check the lot number on the container. Affected lots include 190414, 210414, 220414, and other specific numbers listed in the recall notice. Products were sold between April 2, 2014, and September 25, 2015.
Look for the lot number on the container to determine if it is one of the affected lots listed in the recall notice.
If the product is affected, destroy it immediately to avoid potential regulatory violations.
Sunset Natural Products violated FDA regulations and entered a consent decree requiring them to recall and destroy all products made since April 2, 2014.
Affected lot numbers include 190414, 210414, 220414, 230414, 280514, and other specific numbers listed in the recall notice.
The recall was issued on September 25, 2015, as part of the consent decree entered that date.
The recall notice states that products must be destroyed under FDA supervision, but does not mention refunds or replacements.
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-1024-2017 — Sunset Natural Products Sunset Natural Products Hello, I own a Sunset Natural Products that is covered by recall F-1024-2017 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.
