Recall Register

Food recall: Benefiber Fiber Supplement, Orange Natural Flavor, Non-Thickening Powder, Sugar Free, packaged in 5.7-oz. (35…

Class II FDA enforcement event 65111. Recall start date: . Status in the FDA record: Terminated. Termination date: .

Reason for recall, in the words of FDA

The products are being recalled due to the receipt of a relatively high number of consumer complaints.

Class II, in the words of FDA

a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote

Novartis Consumer Health started this food recall on 7 May 2013. The firm address in the FDA record is in Lincoln, NE. FDA put the recall in Class II. FDA event 65111 has 6 product records. The first FDA enforcement report date is 9 Oct 2013. The record gives the status Terminated, with the termination date 26 Nov 2014.

It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.

FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on . openFDA export of .

Distribution

In the words of FDA.

Product was distributed nationwide and included military distribution. Foreign distribution was made to Panama and Belize.

Recalling firm

Novartis Consumer Health, Lincoln, NE.

Recalling firm: The firm that the FDA record names for a recall.

FDA records how the recall started: Voluntary: Firm initiated.

Products

6 product records in the event.

FDA event 65111: product records
Recall numberProductQuantityClassStatusReport date
F-1959-2013Benefiber Fiber Supplement, Orange Natural Flavor, Non-Thickening Powder, Sugar Free, packaged in 5.7-oz. (35 servings) bottles, UPC 300670068356, 9.4-oz (58 servings) bottles, UPC 300670068585, and 18.7-oz. (115 servings) bottles, UPC 300670068158. Distributed by: Novartis Consumer Health, Inc., Parsippany, NJ…226,381 consumer unitsClass IITerminated9 Oct 2013
F-1960-2013Benefiber Plus Heart Health Non-Thickening Powder, Sugar Free, packaged in 6.4-oz (48 servings) bottles, UPC 300673002487. Distributed by: Novartis Consumer health, Inc., Parsippany, NJ 07054-0622. Made in France.170,220/6.4-oz. (48 servings) bottlesClass IITerminated9 Oct 2013
F-1961-2013Benefiber Fiber Drink Mix, Cherry Pomegranate, Sugar Free, packaged in 5.0-oz. boxes containing 24/0.21-oz. stick packs, UPC 300670107246. Distributed by: Novartis Consumer Health, Inc., Parsippany, NJ 07054-0622. Made in France.162,408/5.0-oz. (24-ct) boxesClass IITerminated9 Oct 2013
F-1962-2013Benefiber Fiber Drink Mix, Kiwi Strawberry, Sugar Free, packaged in 5.0-oz. boxes containing 24/0.21-oz. stick packs, UPC 300670106249. Distributed by: Novartis Consumer Health, Inc., Parsippany, NJ 07054-0622. Made in France.152,016/5.0-oz. (24-ct) boxesClass IITerminated9 Oct 2013
F-1963-2013Benefiber Fiber Supplement Plus Calcium, Orange Natural Flavor, Sugar Free, packaged in 10.76-oz (48 Servings) bottles, UPC 300670108489. Distributed by: Novartis Consumer Health, Inc., Parsippany, NJ 07054-0622. Made in France.110,664/10.76-oz (48 Servings) bottlesClass IITerminated9 Oct 2013
F-1964-2013Benefiber Non-Thickening Powder, Sugar Free, packaged in the following configurations: (1) 2.8-oz. (20 servings) bottles, UPC 300670044206; (2) 4.6-oz. (32 servings) bottles, UPC 300670044329; (3) 5.4-oz. (38 servings) bottles, UPC 300670044381; (4) 8.6-oz. (62 servings) bottles, UPC 300670044626; (5) 12.3-oz. (90…19,900,520 consumer unitsClass IITerminated9 Oct 2013

openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports. Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.

Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.

Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.

Class II: The middle of the three FDA recall classes.

The event in context

Food events that started in 2013
546
Share of these events in Class II
52%
Product records in this event
6Median of the firm: 5
Events of the firm on the register
11

Other events of the firm

Other FDA enforcement events of Novartis Consumer Health
InitiatedProduct (first record)TypeClassRecords
18 Dec 2013Benefiber fiber supplement stick packs, sugar free and taste free, packaged in the following configurations: (1) BenefibFoodClass II1
3 Sep 2013Loratadine, USP 10 mg, Antihistamine, packaged in blister packs. All manufactured by Novartis Consumer Health, Inc, LincDrugClass III1
6 Aug 2013Maalox Extra Strength Antacid with Anti-Gas (calcium carbonate and simethicone) chewable tablets, 1000 mg/60 mg, AssorteDrugClass III9
6 Aug 2013Benefiber, Fiber plus Calcium Supplement, Wild Berry Chewables 90ct, sugar free, chewable tablets bottle. Novartis ConsuFoodClass III5
18 Jun 2013Theraflu Flu & Sore Throat (acetaminophen 650 mg, pheniramine maleate 20 mg, phenylephrine hydrochloride 10 mg) powder pDrugClass II16
6 Jun 2013Excedrin Extra Strength (Acetaminophen 250 mg, Aspirin (NSAID) 250 mg and Caffeine 65 mg), a) 2-ct tablets in pouches b)DrugClass II4
15 May 2013Maximum Strength Comtrex Day/Night Cold & Cough, Acetaminophen 325mg, Chlorpheniramine Maleate 2mg, Dextromethorphan HBRDrugClass III7
19 Apr 2013Lamisil AT (terbinafine hydrochloride cream 1% antifungal), 24 g (.85 oz) tube, Novartis Consumer Health, Parsippany, NJDrugClass III1
7 Mar 2013Myoflex (trolamine salicylate) 10%, Pain Relieving Cream, a) 2-oz tube, b) 4-oz. tube, OTC. The firm name on the label iDrugClass III5
19 Feb 2013Novartis Lamisil AT Cream, Terbinafine Hydrochloride Cream 1% Antifungal, Novartis Consumer Health, Inc., Parsippany, NJDrugClass III5

Novartis Consumer Health: all 11 events

Official channels

Cite this page

Recall Register. FDA enforcement event 65111. https://recallregister.com/fda/ii/65111/. Source: openFDA enforcement reports. Data through .

Sources

Source
openFDA food enforcement reports
Licence
CC0 1.0
Export date
28 Sep 2026
Newest FDA report date on the register
23 Sep 2026

FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.

Questions

Where was the product distributed?
The FDA record gives this distribution: Product was distributed nationwide and included military distribution. Foreign distribution was made to Panama and Belize.
What quantity of product is in FDA event 65111?
The event has 6 product records. The first record gives this quantity: 226,381 consumer units
How did the recall start?
The FDA record says: Voluntary: Firm initiated
How many food recalls of 2013 have the same class?
52% of the 546 food events that started in 2013 are in Class II.