Recall Register

Food, drugs, devices › Novartis Consumer Health

Food recall: Benefiber, Fiber plus Calcium Supplement, Wild Berry Chewables 90ct, sugar free, chewable tablets bottle. Novartis Consu

FDA enforcement event 66013 · Class III · initiated 6 Aug 2013 · status Terminated · terminated 4 Nov 2014

FoodVoluntary: Firm initiated5 product recordsLincoln, NE

FDA enforcement event 66013 is a food recall by Novartis Consumer Health of Lincoln, NE, initiated 6 Aug 2013 and classified Class III, with 5 product records.

FDA defines Class III as a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences. 11% of the 546 food enforcement events initiated in 2013 carry the same class.

Status: Terminated, terminated 4 Nov 2014. Initiation: voluntary: firm initiated. Novartis Consumer Health has 11 enforcement events on this register, with a median of 5 product records per event.

Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.

Recalling firm

Novartis Consumer Health, Lincoln, NE.

Reason for recall

"The lot number and/or expiration date may be illegible on the outer plastic bottle packaging."

Distribution

"Distribution was made nationwide."

Product records

Recall numberProductQuantityClassStatusReport date
F-1903-2013Benefiber, Fiber plus Calcium Supplement, Wild Berry Chewables 90ct, sugar free, chewable tablets bottle. Novartis Consumer Health, Inc, Parsippany, NJ.26,604 unitsClass IIITerminated25 Sep 2013
F-1904-2013Benefiber, Fiber Supplement, Orange Creme Chewables, Sugar Free, 36ct and 100ct chewable tablet bottles. Novartis Consumer Health, Inc, Parsippany, NJ.165,480 unitsClass IIITerminated25 Sep 2013
F-1905-2013Benefiber, Fiber Supplement, 72ct and 114 caplet bottles. Novartis Consumer Health, Inc, Parsippany, NJ.504,456 unitsClass IIITerminated25 Sep 2013
F-1906-2013Benefiber, Fiber Supplement, Assorted Fruit, Sugar Free, 100ct chewable tablets. Novartis Consumer Health, Inc, Parsippany, NJ.419,040 unitsClass IIITerminated25 Sep 2013
F-1907-2013Benefibre, Orange Creme Chewables, 36ct and 100ct chewable tablet bottles. Foreign labeling: Novartis Consumer Health Canada Inc, Mississauga, ON.70,380 unitsClass IIITerminated25 Sep 2013

Context

11%of 2013 food events are Class III546 events that year
5product records in this eventfirm median: 5
11events on this register for the firm

Other enforcement events for 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
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
7 May 2013Benefiber Fiber Supplement, Orange Natural Flavor, Non-Thickening Powder, Sugar Free, packaged in 5.7-oz. (35 servings) FoodClass II6
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

All 11 events for Novartis Consumer Health

Questions and answers

Why was this food recalled?

FDA's record gives the reason for recall as: "The lot number and/or expiration date may be illegible on the outer plastic bottle packaging."

What does Class III mean?

FDA classifies recalls by relative degree of health hazard. Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.

Where was the product distributed?

FDA's distribution pattern field reads: "Distribution was made nationwide."

Is the recall still ongoing?

FDA lists the status as Terminated; the termination date is 4 Nov 2014. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.

Where does this data come from?

openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.

Provenance

Source: openFDA food enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.