Sunset Natural Products is recalling Hepasil dietary supplements manufactured from April 2, 2014, due to a consent decree requiring destruction under FDA supervision. All lots produced between April 2014 and September 2015 are affected.
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 Hepasil dietary supplements made from April 2, 2014, because the company violated FDA regulations and must destroy all products under a consent decree. This recall affects all Hepasil supplements produced between April 2014 and September 2015.
The company violated FDA regulations by marketing dietary supplements without proper compliance, leading to a consent decree that requires all affected products to be destroyed. This recall is part of the company's obligation to comply with FDA rules and avoid future violations.
Anyone who purchased Hepasil dietary supplements between April 2, 2014, and September 25, 2015, is affected. Consumers who have these products should check the lot numbers and expiration dates listed in the recall notice.
Check the lot number and expiration date on the Hepasil product. Known lots include 400414 (exp. 04/17), 070514 (exp. 05/17), 100614 (exp. 06/17), and others listed in the recall notice.
Identify the lot number and expiration date on your Hepasil supplement to confirm if it is affected by this recall.
If your Hepasil supplement is from the affected lots listed in the recall, destroy it immediately to avoid potential regulatory violations.
Sunset Natural Products violated FDA regulations and must destroy all Hepasil supplements manufactured between April 2, 2014, and September 2015 as part of a consent decree.
Affected lots include 400414 (exp. 04/17), 070514 (exp. 05/17), 100614 (exp. 06/17), 110614 (exp. 06/17), 120614 (exp. 06/17), 130614 (exp. 06/17), 140614 (exp. 06/17), 150614 (exp. 06/17), 130515 (exp. 03/18), and 190515 (exp. 05/18).
No, the recall details and affected lots are provided in the official notice. Check the lot number and expiration date on your product to confirm if it is affected.
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-0934-2017 — Sunset Natural Products Sunset Natural Products Hello, I own a Sunset Natural Products that is covered by recall F-0934-2017 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.
