3CS Organics Recalls HIPP Bio Combiotik Infant Formula for Labeling Issues
3CS Organics LLC is recalling HIPP Bio Combiotik infant formula products because they are not FDA approved and not all products are labeled in English.
What this means for you
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, which typically involves minor labeling errors or low-risk contamination. The source text explicitly cites lack of FDA approval and incomplete English labeling as the reasons, without reporting any illnesses or injuries, fitting the Moderate severity criteria for minor labeling errors.
Plain-English summary
3CS Organics LLC is voluntarily recalling HIPP Bio Combiotik infant formula products, including HIPP Bio Combiotik 1, 2, and 3 in 900g and 600g canisters, HIPP Bio Combiotik Pre, and HIPP Comfort Spezialnahrung. The recall involves approximately 25,000 boxes distributed nationwide as well as in Canada, France, Israel, and Mexico. All lots are affected.
The recall was initiated because the products are not FDA approved and not all products are labeled in English. This labeling deficiency may prevent consumers from fully understanding the product contents and usage instructions.
Consumers who have purchased these products should stop using them and contact 3CS Organics LLC for further instructions or a refund. The company is responsible for managing the recall and providing customer support.
The recalled product
- Product
- HIPP Bio Combiotik 1, Canister, 900g (4/case), HIPP Bio Combiotik 2, Canister, 900g (4/case), HIPP Bio Combiotik 3, Canister, 900g (4/case), HIPP Bio Combiotik 1, 600g (4bx/case), HIPP Bio Combiotik 2, 600g (4bx/case), HIPP Bio Combiotik 3, 600g (4/case), HIPP Bio Compiotik, Pr
- 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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