Benefiber Non-Thickening Powder, Sugar Free, packaged in the following configurations…
Novartis Consumer Health recalled this product and the FDA reported the enforcement action on 9 October 2013 as Class II. The recall was initiated by the firm. The products are being recalled due to the receipt of a relatively high number of consumer complaints.
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
- Benefiber 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 servings) bottles, UPC 300670044909; (6) 16.7-oz. (125 servings) bottles, UPC 300670044831; (7) 1.6-lb. (190 servings) bottles, UPC 300670044190; (8) 20.2-oz .(125+25=150 servings) bottles, UPC 300670174590; (9) 10.3-oz. (62+13=75 servings) bottles, UPC 300670175757; (10) Bulk .12-oz. (1 serving) stick pack, UPC 300679999996; (11) 3.45-oz. boxes containing 28/0.12-oz. stick packs, UPC 300670030285; and (12) 4.19-oz. boxes containing 28+6/0.12-oz. stick packs, UPC 300670030346. Distributed by: Novartis Consumer Health, Inc., Parsippany, NJ 07054-0622. Made in France.
- UPC
- 300670044206
- Reason for recall
- The products are being recalled due to the receipt of a relatively high number of consumer complaints.
- Recalling firm
- Novartis Consumer Health
- Firm location
- Lincoln, Nebraska, United States
- Classification
- Class II
- Status
- Terminated
- Recall number
- F-1964-2013
- Quantity
- 19,900,520 consumer units
- Distribution
- Product was distributed nationwide and included military distribution. Foreign distribution was made to Panama and Belize.
- Initiated
- 7 May 2013
- Reported by FDA
- 9 October 2013
- Terminated
- 26 November 2014
- Firm notified by
- Letter
- Product codes
- 2.8-oz. (20 servings) bottles: 10081233, 10084981, 10086954, 10087654, 10089097, 10090985, 10095687, 10095688, 10102413, 10102758, 10106405, 10107215, 10110117, 0112155, 10115504, 10119610, 10120346, 10123373, and 10124210; 4.6-oz. (32 servings) bottles: 10093120, 10099454, 10101273, 10102759, 10104643, 10107322, 10107334, 10109690, 10114152, and 10123951; 5.4-oz. (38 servings) bottles: 10079944, 10079945, 10084982, 10086957, 10087655, 10088811, 10089098, 10089099, 10090986, 10090987, 10095505, 10097339, 10101278, 10102700, 10104644, 10104645, 10104646, 10104647, 10107225, 10108800, 10112148, 10112149, 10116295, 10117967, 10118825, 10120029, 10120452, and 10122150; 8.6-oz. (62 servings) bottles: 10081004, 10081005, 10081006, 10081007, 10081008, 10081009, 10081010, 10081011, 10087657, 10087658, 10089129, 10089130, 10089131, 10090593, 10090992, 10090993, 10090998, 10090999, 10093121, 10094588, 10095506, 10099453, 10101280, 10102760, 10104648, 10104649, 10107227, 10107232, 10108547, 10108549, 10108550, 10112145, 10116296, 10117966, 10118824, 10120023, 10120341, 10120449, 10122151, and 10122152; 12.3-oz. (90 servings) bottles: 10081000, 10081001, 10081002, 10081003, 10084983, 10086955, 10086956, 10087662, 10087663, 10089133, 10089134, 10095507, 10097341, 10101281, 10109497, 10112175, 10115077, 10119609, 10120348, and 10122866; 16.7-oz. (125 servings) bottles: 10080810, 10081012, 10081013, 10081114, 10086958, 10087661, 10089135, 10089136, 10090988, 10090989, 10093124, 10095503, 10095510, 10102761, 10104650, 10104652, 10104654, 10107344, 10112146, 10112147, 10116297, 10117964, 10118823, 10120008, 10120345, 10120799, 10121700, 10122154, 10122956, and 10127499; 25.6-oz. (190 servings) bottles: 10081227, 10081228, 10081229, 10081230, 10081231, 10081232, 10084984, 10084985, 10084986, 10084987, 10084988, 10087659, 10087660, 10089137, 10089138, 10090994, 10090995, 10090996, 10095513, 10095514, 10102762, 10102763, 10104655, 10107381, 10108545, 10112153, 10113299, 10118822, 10120006, 10122129, 10122230, 10122458, and 10124273; 20.2-oz. (125+25=150 servings) bottles: 10100270, 10100272, and 10120315; 10.3-oz. (62+13=75 servings) bottles: 10106742, 10109551, 10111859, 10116666, and 10123229; Bulk .12-oz. (1-ct.) stick packs: 24621901, 24621902, 24621903, 24621904, 24807701, 24807702, 24807703, 24807704, 24807705, 24807706, 24807707, 24930501, 24930502, 24930503, 24930504, 25318601, 25318602, 25318603, and 25318604; 3.45-oz. (28-ct. stick pack) boxes: 10115152, 10115284, 10115617, 10116201, 10116301, 10116302, 10116604, 10121341, 10122650, 10127826, 10113682A, 10114422A, 24329201, 24329202, 24329203, 24329204, 24506601, 24506602, 24596603, 24596604, 24596605, 24767501, 24767502, 24767503, 24767504, 24767506, 24767507, 25239401, 25239402, 25239403, 25239404, 25239405, 25239406, 25239407, 25239408, 25239409, and 25239410; and 4.19-oz. (28+6 stick pack) boxes: 10107198, 10116607, 10116608, 10122652, and 10122934.
Reading this record
Five things about this record are not in the record itself, and each one changes how it should be read.
- Class II means the FDA judged a remote probability of serious harm, or a probability of temporary or medically reversible harm. 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 6 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 6 separate recalls, which almost every published figure does, overstates it by a factor of 6. All 6 of them are listed on this page.
- The recall ran for 19 months, from 7 May 2013 to termination on 26 November 2014. 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 5 months 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 6 enforcement records for this one recall, one per product code. This page carries all of them; the 5 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 Novartis Consumer Health
The FDA opens one enforcement record per product code, so several of these are frequently one recall event. 11 other records name this firm.
All 12 records for Novartis Consumer Health
All 2013 recalls · All FDA food recall data
Behind every recall is a clause somebody has to produce evidence for at their next audit. Krolda maps supplier documents to the clause they satisfy in FSSC 22000, IFS Food and 21 CFR 117, and routes the corrective action when the evidence is missing.
Early accessRecall records come from the openFDA food enforcement API, published by the U.S. Food and Drug Administration in the public domain. Krolda adds the hazard classification and the clause mapping; neither is an FDA determination. Always check the FDA notice before acting on a recall.