The Recall Desk
Agency classClass IIIOur severity:LowFDA (Food)·F-1906-2013·Announced 2013-09-25

Novartis Recalls Benefiber Fiber Supplement Due to Illegible Packaging Labels

Novartis Consumer Health is recalling 419,040 units of Benefiber chewable tablets because the lot number and expiration date may be illegible on the outer plastic bottle packaging.

The agency’s classification

FDA (Food): Class III

Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 1/5 (Low).

Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.

Our severity reasoning: The recall is classified as FDA Class III, which indicates the product is not likely to cause adverse health consequences. The hazard is limited to packaging legibility issues.

Plain-English summary

Novartis Consumer Health, Inc. is recalling 419,040 units of Benefiber, Fiber Supplement, Assorted Fruit, Sugar Free, 100ct chewable tablets. The recall involves specific lots with expiration dates ranging from May 2011 to December 2011. The product was distributed nationwide.

The reason for the recall is that the lot number and/or expiration date may be illegible on the outer plastic bottle packaging. This labeling issue prevents consumers from verifying the specific lot and expiration date of the product.

Consumers who have purchased these specific lots of Benefiber chewable tablets should check the outer plastic bottle packaging for the affected lot numbers and expiration dates listed in the recall notice. If the product matches the recalled lots, consumers should stop using it and contact the manufacturer for further instructions.

The recalled product

Product
Benefiber, Fiber Supplement, Assorted Fruit, Sugar Free, 100ct chewable tablets. Novartis Consumer Health, Inc, Parsippany, NJ.
Manufacturer
Novartis Consumer Health
Category
Food — Dietary Supplement
Hazard
Affected units
419,040

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

  • Lot Number and Expiration date 10110708
  • 5/12/2011
  • 10110806
  • 5/10/2011
  • 10111858
  • 6/8/2011
  • 10112132
  • 6/17/2011
  • 10113256
  • 7/25/2011
  • 10116303
  • 9/9/2011
  • 10116444
  • 9/8/2011
  • 10118336
  • 10/6/2011
  • 10118337
  • 10119374
  • 10/31/2011
  • 10119376

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 5 recalled by Novartis Consumer Health under a single FDA (Food) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 5 products in this recall →

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