HIPP Anti-Reflux Infant Formula Recalled for Lack of FDA Approval
3CS ORGANICS LLC is recalling HIPP Anti-Reflux AR Bio-Spezialnahrung because the product is not FDA approved and lacks complete English labeling.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, but the source text explicitly states no illnesses or injuries are reported and the hazard is related to regulatory approval and labeling rather than a specific pathogen or physical defect, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
3CS ORGANICS LLC is recalling HIPP Anti-Reflux AR Bio-Spezialnahrung, 500g (4/case). The recall involves 25,000 boxes distributed nationwide in the United States, as well as in Canada, France, Israel, and Mexico. All lots of the product are affected.
The recall was initiated because the product is not FDA approved and not all products are labeled in English. The source text does not specify any reported illnesses or injuries associated with the product.
Consumers who have purchased this product should stop using it and contact the recalling firm for further instructions. The source text does not provide specific contact details or a refund policy.
The recalled product
- Product
- HIPP Anti-Reflux AR Bio-Spezialnahrung, 500g (4/case)
- Manufacturer
- 3CS ORGANICS LLC
- Category
- Food — Infant Formula
- Affected units
- 25,000
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 (1)
- All Lots
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 9 recalled by 3CS ORGANICS LLC 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 9 products in this recall →Related recalls
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