HIPP Infant Formula Recalled for Lack of FDA Approval and English Labels
3CS Organics LLC is recalling HIPP infant formula products because they are not FDA approved and lack 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 cites labeling and approval status issues rather than specific contamination or injury reports, aligning with the rubric for moderate severity involving labeling errors.
Plain-English summary
3CS Organics LLC is voluntarily recalling HIPP Tetrapack-Liquid Single Serve Combiotik Hungry Infant and HIPP Tetrapak-Liquid Single Serve Combiotik First Infant Milk. The recall involves 25,000 boxes of these 200mL single-serve infant formula products.
The FDA has determined that the recalled products are not FDA approved and that not all products are labeled in English. This recall is classified as Class II by the agency.
The products were distributed nationwide as well as in Canada, France, Israel, and Mexico. Consumers should stop using the recalled products and contact the recalling firm for further instructions.
The recalled product
- Product
- HIPP Tetrapack-Liquid , Single Serve Combiotik Hungry Infant, 200mL (6pk/24cases), HIPP Tetrapak-Liquid, Single Serve Combiotik First Infant Milk, 200mL (6pk/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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