Novartis Recalls Benefibre Orange Creme Chewables Due to Illegible Labeling
Novartis Consumer Health is recalling specific lots of Benefibre Orange Creme Chewables because the lot number and expiration date may be illegible on the packaging.
What this means for you
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 unlikely to cause adverse health consequences. The hazard is limited to packaging labeling issues (illegible text) rather than a direct safety threat like contamination or injury.
Plain-English summary
Novartis Consumer Health is voluntarily recalling 70,380 units of Benefibre Orange Creme Chewables in 36-count and 100-count bottles. The recall affects specific lots distributed nationwide, including those with foreign labeling from Novartis Consumer Health Canada Inc. The affected lot numbers and expiration dates are: 10101294 (12/31/2013), 10114155 (4/30/2014), 10097346 (8/31/2013), 10104669 (12/31/2013), 10117018 (1/31/2014), 10117019 (4/30/2014), and 10120625 (8/31/2014).
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 Benefibre Orange Creme Chewables should check their packaging for the affected lot numbers and expiration dates listed above. If the product matches the recalled lots, consumers should stop using it and contact Novartis Consumer Health for further instructions or a refund.
The recalled product
- Product
- Benefibre, Orange Creme Chewables, 36ct and 100ct chewable tablet bottles. Foreign labeling: Novartis Consumer Health Canada Inc, Mississauga, ON.
- Manufacturer
- Novartis Consumer Health
- Category
- Drug — Dietary Supplement
- Hazard
- Affected units
- 70,380
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 (12)
- Lot Number and Expiration date 36ct bottle: 10101294
- 12/31/2013
- 10114155
- 4/30/2014 100ct bottle: 10097346
- 8/31/2013
- 10104669
- 10117018
- 1/31/2014
- 10117019
- 4/30/2014
- 10120625
- 8/31/2014.
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.
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