Sunset Natural Products Inc. recalls Gludo bulk capsules manufactured from April 2, 2014 onward due to FDA consent decree requiring destruction. Known lots and expiration dates listed.
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 Inc. is recalling all Gludo bulk capsules made or distributed starting April 2, 2014. This recall follows a consent decree with the FDA that requires the company to destroy these supplements under FDA supervision.
The hazard comes from a consent decree with the FDA that prohibits the company from marketing dietary supplements until they destroy all recalled products. The recall is not due to a safety issue but a legal requirement to comply with FDA regulations.
Anyone who owns or uses Gludo bulk capsules made or distributed from April 2, 2014 onward. People most at risk are those who have the specific lots listed in the recall notice.
Check for Gludo bulk capsules with lot numbers: 030614 (exp. 07/17), 460814 (exp. 09/17), 080914 (exp. 10/17), 090914 (exp. 10/17), 021114 (exp. 11/17), 050115 (exp. 02/18), or 030415 (exp. 05/18).
Identify the lot number on the Gludo bulk capsule packaging to determine if it is in the recalled list.
If the product is in the recalled list, destroy it immediately to comply with the FDA consent decree.
Sunset Natural Products Inc. must destroy these products as part of a consent decree with the FDA that prohibits them from marketing dietary supplements until they comply with FDA regulations.
The affected lots are: 030614 (exp. 07/17), 460814 (exp. 09/17), 080914 (exp. 10/17), 090914 (exp. 10/17), 021114 (exp. 11/17), 050115 (exp. 02/18), and 030415 (exp. 05/18).
No, if your Gludo bulk capsules are not in the listed lots, they are not affected by this recall.
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-0986-2017 — Sunset Natural Products Sunset Natural Products Hello, I own a Sunset Natural Products that is covered by recall F-0986-2017 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.
