The Recall Desk
Agency classClass IIOur severity:HighFDA (Food)·F-0418-2023·Announced 2023-03-15

Given Imaging SmartBar Cereal Bar Recalled for Potential Tobacco Beetle Contamination

Given Imaging Ltd. is recalling SmartBar Cereal Bars because they may be contaminated with tobacco beetles. Consumers should not consume the affected product.

The agency’s classification

FDA (Food): Class II

Class II is 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.

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 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is an FDA Class II recall involving foreign material (tobacco beetle) contamination in a food product with no reported illnesses. Per the rubric, this constitutes a risk-of-harm product where injury has not yet been reported, warranting a score of 3.

Plain-English summary

Given Imaging Ltd. is recalling SmartBar Cereal Bars because they may be contaminated with tobacco beetles.

The affected product is SmartBar Cereal Bar with net weight 2.53 oz (72 g). Affected units bear lot numbers 73614B, 74200B, or 74800B, with corresponding expiration dates of 19-Jan-2023, 10-Jun-2023, or 20-Jul-2023. Approximately 2,665 units are subject to this recall. The product was manufactured in Israel for Given Imaging Ltd. (Mansfield, MA) and distributed in all U.S. states as well as Australia, Canada, New Zealand, Sweden, Switzerland, Taiwan, and the United Kingdom.

Consumers should not consume the affected product. Those who have consumed the affected product and have health concerns should consult their healthcare provider.

The recalled product

Product
Given Imaging SmartBar Cereal Bar; Net Weight 2.53 oz (72 g); Ingredients: glucose syrup, soy crisps, oats, pea protein, puffed wheat (wheat, sugar), concentrated pineapple juice, fructose, dried cranberries (cranberries, sugar, sunflower oil), dried apples, brown sugar, invert…
Manufacturer
Given Imaging Ltd.
Affected units
2,665

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 (5)

  • Model Number: FGS-0505 Lot Numbers: 73614B
  • 74200B
  • 74800B Expiration Dates: 19-Jan 2023
  • 10-Jun-2023
  • 20-Jul-2023 GTIN: 04260167482705

Distribution

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