GU Energy Gels: Vanilla Bean, Gel; GUGEL 1 Pkt; item # 123017, UPC: 769493100023; GUGEL…

Advanced Food Concepts recalled this product and the FDA reported the enforcement action on 8 August 2018 as Class III. The recall was initiated by the firm. Firm was notified by L-Leucine supplier that product may contain cyclamates. Testing of the product confirmed this and a recall was initiated.

The record

Every field below is published by the FDA in the openFDA food enforcement database. Check the FDA notice before acting on any recall: this page is a reading of the public record, not a substitute for it.

Product

GU Energy Gels: Vanilla Bean, Gel; GUGEL 1 Pkt; item # 123017, UPC: 769493100023; GUGEL 8Pkt Box, item # 123032, UPC: 769493900012; GUGEL 15 Serve Pkt, item # 124099, UPC: 769493100870; GUGEL 24Pkt Box; item number 123049, UPC:. 769493200020.

UPC

769493100023

Reason for recall

Firm was notified by L-Leucine supplier that product may contain cyclamates. Testing of the product confirmed this and a recall was initiated.

Recalling firm

Advanced Food Concepts

Firm location

Berkeley, California, United States

Classification

Class III

Status

Terminated

Recall number

F-1699-2018

Quantity

22, 848, 401 (All Domestically)

Distribution

worldwide distribution

Initiated

18 July 2018

Reported by FDA

8 August 2018

Terminated

14 November 2019

Firm notified by

Letter

Product codes

All lots

Reading this record

Five things about this record are not in the record itself, and each one changes how it should be read.

• Class III means the FDA judged that the product was unlikely to cause harm but violated FDA labelling or manufacturing regulation. The class is assigned by an agency health hazard evaluation under 21 CFR 7.41, not by the firm.
• The firm started this recall itself. Most FDA food recalls are voluntary, and a recall is a food safety plan working rather than failing. The circumstances in which the agency asks for one instead are set out in 21 CFR 7.45.
• This is one of 43 records covering the same recall event. The FDA opens one enforcement record per product code, so a recall of a product line appears here many times. Counting these records as 43 separate recalls, which almost every published figure does, overstates it by a factor of 43. All 43 of them are listed on this page.
• The recall ran for 16 months, from 18 July 2018 to termination on 14 November 2019. Termination means the agency judged that all reasonable effort had been made, under 21 CFR 7.55, and it says nothing about whether product remained in circulation.
• The FDA published the enforcement report 3 weeks after the firm began the recall.
• The product description on this record names no food this site can classify, so it appears on no food-type page. That is a limit of the description rather than of the recall.

Every product in this recall

The FDA opened 43 enforcement records for this one recall, one per product code. This page carries all of them; the 42 below each have their own page with that product’s lot codes and distribution, and search engines are pointed here for the recall as a whole.

Other records from Advanced Food Concepts

The FDA opens one enforcement record per product code, so several of these are frequently one recall event. 42 other records name this firm.

All 43 records for Advanced Food Concepts

All 2018 recalls · All FDA food recall data