Key Takeaway

Saw Palmetto Dietary Supplement (unknown container size) by Sunset Natural Products Inc. was recalled on October 13, 2015. The hazard: Pursuant to a consent decree that prohibits the company and its owners for marketing dietary supplements until they, among other things, recall and de...

FDA Food Class II Terminated

Saw Palmetto Dietary Supplement (unknown container size)

Recalled: October 13, 2015 ~Unknown units affected F-1020-2017

Description

Saw Palmetto Dietary Supplement (unknown container size)

Hazard / Reason

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.

Class II: Product that may cause temporary or medically reversible health consequences.

Class II indicates the product may cause temporary or medically reversible health effects. The probability of serious harm is considered remote.

Products Affected

Saw Palmetto Dietary Supplement (unknown container size)

Food

Saw Palmetto Dietary Supplement (unknown container size)

Food

Company Information

Sunset Natural Products Inc.

Miami, FL, United States

View all 173 recalls by Sunset Natural Products Inc. →

Distribution

Products distributed to Florida, Nevada and the Dominican Republic

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Frequently Asked Questions

Is this recall still active?

Check the status badge at the top of this page. "Ongoing" means the recall is still active and you should follow the remedy instructions. "Completed" or "Terminated" means the recall process has concluded, though the safety issue remains relevant for any unrepaired products.

How do I check if my product is affected?

Compare the model number, lot code, serial number, or date range listed in the recall notice with the information on your product's label or packaging. For vehicles, check your VIN at NHTSA.gov/Recalls.

What remedy is available for this recall?

Check the remedy section above or contact the manufacturer directly for current remedy options.

Where can I find the original recall notice?

This recall was issued by FDA Food. Visit the agency's official website for the original notice.

Data sourced from FDA Food Enforcement. Recall information may not reflect the most current status. RecallDex is not affiliated with any US government agency. Contact the manufacturer or relevant agency for the latest information.