Sunset Natural Products Inc. recalls Prusha bulk capsules manufactured from April 2, 2014, due to a consent decree requiring destruction under FDA supervision. Affected lots include those with expiration date 05/17.
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 Prusha bulk capsules made from April 2, 2014, because they violated FDA regulations and must destroy all such products. This recall is part of a legal settlement requiring the company to stop selling dietary supplements until they meet FDA compliance standards.
The hazard stems from the company's violation of FDA regulations, which led to a consent decree requiring the destruction of all recalled products. The company must stop marketing dietary supplements until they meet FDA compliance standards and receive written permission to resume operations.
Anyone who owns or uses Prusha bulk capsules manufactured between April 2, 2014, and September 25, 2015, is affected. Consumers most at risk are those who have the capsules with lot number 380514 and expiration date 05/17.
Check for lot number 380514 with an expiration date of May 17, 2017. The capsules were manufactured between April 2, 2014, and September 25, 2015, as per the consent decree.
Destroy all Prusha bulk capsules with lot number 380514 and expiration date 05/17.
Sunset Natural Products Inc. violated FDA regulations and must destroy all Prusha bulk capsules manufactured between April 2, 2014, and September 25, 2015, as part of a consent decree.
Destroy all Prusha bulk capsules with lot number 380514 and expiration date 05/17.
The recall record does not specify a deadline for destruction.
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-0980-2017 — Sunset Natural Products Sunset Natural Products Hello, I own a Sunset Natural Products that is covered by recall F-0980-2017 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.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
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.
