Class IITerminated in FDA datasetRecall initiated Oct 13, 2015

Horny Goat Weed, bulk capsules

Recalling firm: Sunset Natural Products Inc.

Why it was recalled

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…

Historical recall record. This is not a new recall announcement. “Terminated” describes the FDA recall process; it does not certify that an individual package is safe. FDA termination date: Apr 10, 2017.

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ProductHorny Goat Weed, bulk capsules

FDA code information

As persuant to the Consent Decree, the firm agreed to "recall and destroy, under FDA's supervision, in accordance with the procedures provided in paragraph 6, ALL dietary supplements that were manufactured, prepared, processed, packed, labeled, held and/or distributed between April 2, 2014 and the date of entry of this Decree." The Decree was entered on September 25, 2015. Known lots and expiration dates: Lot # 320414 Exp. Date 05/17, Lot # 590614 Exp. Date 07/17, Lot # 510814 Exp. Date 09/17, Lot # 210914 Exp. Date 09/17, Lot # 540914 Exp. Date 10/17, Lot # 570914 Exp. Date 10/17, Lot # 151014 Exp. Date 11/17, Lot # 350215 Exp. Date 03/18, Lot # 350415 Exp. Date 05/18, Lot # 020115 Exp. Date 01/18

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Full FDA record and distribution details

Original product description

Horny Goat Weed, bulk capsules

Extracted codes and context

Type	Code / value	Context
lot	`020115`	. Date 11/17, Lot # 350215 Exp. Date 03/18, Lot # 350415 Exp. Date 05/18, Lot # 020115 Exp. Date 01/18
lot	`151014`	. Date 09/17, Lot # 540914 Exp. Date 10/17, Lot # 570914 Exp. Date 10/17, Lot # 151014 Exp. Date 11/17, Lot # 350215 Exp. Date 03/18, Lot # 350415 Exp. Date 05/18, Lot # 020115 Exp. Date 01/18
lot	`210914`	. Date 05/17, Lot # 590614 Exp. Date 07/17, Lot # 510814 Exp. Date 09/17, Lot # 210914 Exp. Date 09/17, Lot # 540914 Exp. Date 10/17, Lot # 570914 Exp. Date 10/17, Lot # 151014 Exp. Date 11/17, Lot # 350215
lot	`320414`	ee was entered on September 25, 2015. Known lots and expiration dates: Lot # 320414 Exp. Date 05/17, Lot # 590614 Exp. Date 07/17, Lot # 510814 Exp. Date 09/17, Lot # 210914 Exp. Date 09/17, Lot # 540914
lot	`350215`	. Date 10/17, Lot # 570914 Exp. Date 10/17, Lot # 151014 Exp. Date 11/17, Lot # 350215 Exp. Date 03/18, Lot # 350415 Exp. Date 05/18, Lot # 020115 Exp. Date 01/18
lot	`350415`	. Date 10/17, Lot # 151014 Exp. Date 11/17, Lot # 350215 Exp. Date 03/18, Lot # 350415 Exp. Date 05/18, Lot # 020115 Exp. Date 01/18
lot	`510814`	ration dates: Lot # 320414 Exp. Date 05/17, Lot # 590614 Exp. Date 07/17, Lot # 510814 Exp. Date 09/17, Lot # 210914 Exp. Date 09/17, Lot # 540914 Exp. Date 10/17, Lot # 570914 Exp. Date 10/17, Lot # 151014
lot	`540914`	. Date 07/17, Lot # 510814 Exp. Date 09/17, Lot # 210914 Exp. Date 09/17, Lot # 540914 Exp. Date 10/17, Lot # 570914 Exp. Date 10/17, Lot # 151014 Exp. Date 11/17, Lot # 350215 Exp. Date 03/18, Lot # 350415
lot	`570914`	. Date 09/17, Lot # 210914 Exp. Date 09/17, Lot # 540914 Exp. Date 10/17, Lot # 570914 Exp. Date 10/17, Lot # 151014 Exp. Date 11/17, Lot # 350215 Exp. Date 03/18, Lot # 350415 Exp. Date 05/18, Lot # 020115
lot	`590614`	, 2015. Known lots and expiration dates: Lot # 320414 Exp. Date 05/17, Lot # 590614 Exp. Date 07/17, Lot # 510814 Exp. Date 09/17, Lot # 210914 Exp. Date 09/17, Lot # 540914 Exp. Date 10/17, Lot # 570914

Original FDA recall 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.

Recall details

Recall number: F-0974-2017
Event ID: 74054
FDA status: Terminated
Initiated: Oct 13, 2015
Reported: Jan 4, 2017
Classified: Dec 28, 2016
Terminated: Apr 10, 2017
Quantity: 1,100,000
Location: Miami, FL, United States
Initiation type: FDA Mandated
Notification: Letter

Where it was distributed

Products distributed to Florida, Nevada and the Dominican Republic

FDA source record · F-0974-2017

Data updated September 16, 2026. View official FDA data ↗

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