CLASS II Food recall · Reported 4 Jan 2017 · FDA Enforcement Report

Hepasil, (various bulk amounts) recalled by Sunset Natural Products

Sunset Natural Products is recalling Hepasil, (various bulk amounts), distributed in Florida, Nevada. The recall was initiated on 13 Oct 2015 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesAs 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 # 400414 Exp. Date 04/17, Lot # 070514 Exp. Date 05/17, Lot # 100614 Exp. Date 06/17, Lot # 110614 Exp. Date 06/17, Lot # 120614 Exp. Date 06/17, Lot # 130614 Exp. Date 06/17, Lot # 140614 Exp. Date 06/17, Lot # 150614 Exp. Date 06/17, Lot # 130515 Exp. Date 03/18, Lot # 190515 Exp. Date 05/18

Quantity recalled2,650,000 capsules

Do not eat it. Return it to the store for a refund or throw it away. If you have symptoms after eating it, contact a doctor.

Recall details

Recall number: F-0934-2017
FDA event ID: 74054
Recalling firm: Sunset Natural Products, Miami, FL
Brand: Hepasil
Classification: Class II
Status: Terminated
Recall initiated: 13 Oct 2015
FDA classified: 28 Dec 2016
Reported: 4 Jan 2017
Type: FDA Mandated
Customers notified by: Letter
Reason category: Manufacturing (CGMP) Deviations
Product category: Other

Timeline

13 Oct 2015	Recall initiated by company
28 Dec 2016	Classified by FDA	+442 days
4 Jan 2017	Published in enforcement report	+7 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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.

Product as listed by the FDA

Hepasil, (various bulk amounts)

Where it was distributed

Products distributed to Florida, Nevada and the Dominican Republic

Florida Nevada

Questions about this recall

Is Hepasil, (various bulk amounts) recalled?

Yes. Sunset Natural Products recalled Hepasil, (various bulk amounts) on 13 Oct 2015. The recall is Class II and its status is Terminated. Recall number F-0934-2017.

Why was it recalled?

Which lots are affected?

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 # 400414 Exp. Date 04/17, Lot # 070514 Exp. Date 05/17, Lot # 100614 Exp. Date 06/17, Lot # 110614 Exp. Date 06/17, Lot # 120614 Exp. Date 06/17, Lot # 130614 Exp. Date 06/17, Lot # 140614 Exp. Date 06/17, Lot # 150614 Exp. Date 06/17, Lot # 130515 Exp. Date 03/18, Lot # 190515 Exp. Date 05/18

Where was it sold?

Products distributed to Florida, Nevada and the Dominican Republic

What should I do if I have it?

Do not eat it. Return it to the store for a refund or throw it away. If you have symptoms after eating it, contact a doctor.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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