CLASS II Food recall · Reported 13 Dec 2017 · FDA Enforcement Report

Sweetening Enhancer , the product is packaged as follows recalled

FLAVORx is recalling Sweetening Enhancer , the product is packaged as follows: Fillmaster Auto Sweetening. The recall was initiated on 13 Oct 2017 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesFillmaster Auto Sweetening Enhancer AQ, 4oz Bottle, Lot #3281712 / Exp. Date 12/2018 Fillmaster Auto Sweetening Enhancer AQ, 4oz Bottle, Lot #4281712 / Exp. Date 03/2019 Fillmaster Auto Sweetening Enhancer AQ, 4oz Bottle, Lot #5181712 / Exp. Date 03/2019 Fillmaster Auto Sweetening Enhancer AQ, 4oz Bottle, Lot #8151712 / Exp. Date 03/2019 Fillmaster Auto Sweetening Enhancer AQ, 4oz Bottle, Lot #8311712 / Exp. Date 03/2019 Fillmaster Auto Sweetening Enhancer AQ, 4oz Bottle, Lot #9011712 / Exp. Date 03/2019

Quantity recalled420 bottles

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-0428-2018
FDA event ID: 78554
Recalling firm: FLAVORx, Columbia, MD
Brand: Sweetening Enhancer
Classification: Class II
Status: Terminated
Recall initiated: 13 Oct 2017
FDA classified: 6 Dec 2017
Reported: 13 Dec 2017
Type: Voluntary: Firm initiated
Customers notified by: E-Mail
Reason category: Potency & Assay
Product category: Other

Timeline

13 Oct 2017	Recall initiated by company
6 Dec 2017	Classified by FDA	+54 days
13 Dec 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

FLAVORx Inc. has decided to recall the following product FLAVORx Sweetening Enhancer, which is a food additive used as a Pharmacy Compounding Material, because of subsequent testing of the product in there ongoing stability program indicated that there was microbial growth in their sweetening enhancer product.

Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.

Product as listed by the FDA

FLAVORx Sweetening Enhancer , the product is packaged as follows: Fillmaster Auto Sweetening Enhancer AQ, 4oz Bottle, Lot #3281712 / Exp. Date 12/2018 Fillmaster Auto Sweetening Enhancer AQ, 4oz Bottle, Lot #4281712 / Exp. Date 03/2019 Fillmaster Auto Sweetening Enhancer AQ, 4oz Bottle, Lot #5181712 / Exp. Date 03/2019 Fillmaster Auto Sweetening Enhancer AQ, 4oz Bottle, Lot #8151712 / Exp. Date 03/2019 Fillmaster Auto Sweetening Enhancer AQ, 4oz Bottle, Lot #8311712 / Exp. Date 03/2019 Fillmaster Auto Sweetening Enhancer AQ, 4oz Bottle, Lot #9011712 / Exp. Date 03/2019 #50 per box 4oz bottles Package type: Amber Glass Boston Round Bottles

Where it was distributed

Thru out the United Sates and two foreign countries

Questions about this recall

Why was it recalled?

Which lots are affected?

Fillmaster Auto Sweetening Enhancer AQ, 4oz Bottle, Lot #3281712 / Exp. Date 12/2018 Fillmaster Auto Sweetening Enhancer AQ, 4oz Bottle, Lot #4281712 / Exp. Date 03/2019 Fillmaster Auto Sweetening Enhancer AQ, 4oz Bottle, Lot #5181712 / Exp. Date 03/2019 Fillmaster Auto Sweetening Enhancer AQ, 4oz Bottle, Lot #8151712 / Exp. Date 03/2019 Fillmaster Auto Sweetening Enhancer AQ, 4oz Bottle, Lot #8311712 / Exp. Date 03/2019 Fillmaster Auto Sweetening Enhancer AQ, 4oz Bottle, Lot #9011712 / Exp. Date 03/2019

Where was it sold?

Thru out the United Sates and two foreign countries

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

Other products in this recall event

2 other products · FDA event 78554

Reported	Class	Recall	Company	Reason	Where
13 Dec 2017	CLASS II	Sweetening Enhancer , the product is packaged as follows recalledSweetening Enhancer	FLAVORx	Potency & Assay	MD
13 Dec 2017	CLASS II	Sweetening Enhancer , the product is packaged as follows recalledSweetening Enhancer	FLAVORx	Potency & Assay	MD

More recalls from FLAVORx

All 3

Reported	Class	Recall	Company	Reason	Where
13 Dec 2017Food	CLASS II	Sweetening Enhancer , the product is packaged as follows recalledSweetening Enhancer	FLAVORx	Potency & Assay	MD
13 Dec 2017Food	CLASS II	Sweetening Enhancer , the product is packaged as follows recalledSweetening Enhancer	FLAVORx	Potency & Assay	MD

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