F-0971-2017 Class II Terminated

Recalled by Sunset Natural Products Inc. — Miami, FL

FDA food recall F-0971-2017 was initiated by Sunset Natural Products Inc. on Oct 13, 2015 and is designated Class II. 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… The recall status is terminated (terminated Apr 10, 2017). Affected quantity: 12,310,000 capsules.

Recall Details

Product Type
Food
Report Date
Jan 4, 2017
Initiation Date
Oct 13, 2015
Termination Date
Apr 10, 2017
Voluntary/Mandated
FDA Mandated
Product Quantity
12,310,000 capsules

Product Description

Aloe Vera 500 mg, bulk capsules

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.

Distribution Pattern

Products distributed to Florida, Nevada and the Dominican Republic

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 # 170414 Exp. Date 05/17, Lot # 260414 Exp. Date 05/17, Lot # 270414 Exp. Date 05/17, Lot # 430414 Exp. Date 05/17, Lot # 440414 Exp. Date 07/17, Lot # 450414 Exp. Date 06/17, Lot # 170514 Exp. Date 06/17, Lot # 180514 Exp. Date 06/17, Lot # 340514 Exp. Date 08/17, Lot # 350514 Exp. Date 08/17, Lot # 360514 Exp. Date 09/17, Lot # 370514 Exp. Date 08/17, Lot # 050814 Exp. Date 09/17, Lot # 060814 Exp. Date 10/17, Lot # 070814 Exp. Date 10/17, Lot # 080814 Exp. Date 10/17, Lot # 030914 Exp. Date 10/17, Lot # 040914 Exp. Date 10/17, Lot # 050914 Exp. Date 10/17, Lot # 060914 Exp. Date 10/17, Lot # 190914 Exp. Date 09/17, Lot # 220914 Exp. Date 09/17, Lot # 240914 Exp. Date 09/17, Lot # 380914 Exp. Date 10/17, Lot # 390914 Exp. Date 11/17, Lot # 400914 Exp. Date 11/17, Lot # 410914 Exp. Date 11/17, Lot # 501014 Exp. Date 11/17, Lot # 511014 Exp. Date 11/17, Lot # 521014 Exp. Date 11/17, Lot # 531014 Exp. Date 11/17

Source

Dataset
openFDA food recall enforcement reports
FDA record
This recall in openFDA (JSON)
Enforcement Report
Search FDA's Enforcement Report for F-0971-2017
openFDA file date
Oct 23, 2026
Loaded by RegDataLab
Oct 23, 2026

These dates say when openFDA published the data file and when RegDataLab last loaded it.