Agency classClass IIOur severity:Moderate FDA (Food)·F-2462-2017·Announced 2017-07-19

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.

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, 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…
Manufacturer: 3CS ORGANICS LLC
Category: Food — Infant Formula
Hazard: mis-labeling
unapproved-product
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 →

Same manufacturer · 3CS ORGANICS LLC

See all →

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HIPP Infant Formula Recalled for Lack of FDA Approval and English Labels
FDA (Food) · 2017-07-19
Moderate
3CS Organics Recalls HIPP Infant Formula Due to Labeling Issues
FDA (Food) · 2017-07-19
Moderate
3CS Organics Recalls HIPP Organic Infant Milk Products for Labeling Issues
FDA (Food) · 2017-07-19

Same hazard · mis labeling