Sunset Natural Products recalls Maca 250 mg bulk capsules manufactured from April 2, 2014, due to a consent decree requiring destruction under FDA supervision. Affected lots include 190814 (exp 08/17) and 030115 (exp 02/18).
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 Maca 250 mg bulk capsules made from April 2, 2014, because they violated FDA regulations. This recall is part of a consent decree that requires the company to destroy all affected products under FDA supervision.
The hazard stems from the company's violation of FDA regulations, which led to a consent decree requiring them to recall and destroy all affected products. The recall is not due to a safety risk in the product itself but rather a legal compliance issue.
Anyone who owns or uses Maca 250 mg bulk capsules manufactured between April 2, 2014, and September 25, 2015. People who have the specific lots listed (190814 or 030115) are most at risk.
Check for Maca 250 mg bulk capsules with lot numbers 190814 (expires 08/17) or 030115 (expires 02/18). Products manufactured between April 2, 2014, and September 25, 2015, are affected.
Look for lot numbers 190814 or 030115 on the packaging to confirm if the product is affected.
If you have the affected lots, destroy them immediately to comply with the recall.
Sunset Natural Products violated FDA regulations and must destroy all affected products under a consent decree to comply with legal requirements.
Lots 190814 (expires 08/17) and 030115 (expires 02/18) manufactured between April 2, 2014, and September 25, 2015.
No, only products with the specific lot numbers listed are 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-0999-2017 — Sunset Natural Products Sunset Natural Products Hello, I own a Sunset Natural Products that is covered by recall F-0999-2017 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.