3CS Organics Recalls HIPP Infant Formula Due to Labeling Issues
3CS Organics LLC is recalling HIPP infant formula products because they are not FDA approved and lack full 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, which typically involves a temporary or medically reversible health risk. The specific hazard is labeling non-compliance (lack of English labels and FDA approval), which fits the 'Moderate' criteria for labeling errors without reported illness.
Plain-English summary
3CS Organics LLC is voluntarily recalling specific HIPP infant formula products, including HIPP HA Combiotik HA 1, HIPP Combiotik HA 2, HA Combiotik Pre HA, and HIPP Combiotic Growing Up Milk 3. The recall involves 25,000 boxes distributed nationwide as well as in Canada, France, Israel, and Mexico.
The recall was initiated because the products are not FDA approved and not all products are labeled in English. This labeling deficiency prevents consumers from fully understanding the product contents and usage instructions in their primary language.
Consumers who have purchased these products should stop using them and contact the recalling firm for further instructions. The recall covers all lots of the affected products.
The recalled product
- Product
- HIPP HA Combiotik HA 1, 500g (4/case), HIPP Combiotik HA 2, 500g (4/case), HA Combiotik Pre HA, 500g (4/case), HIPP Combiotic Growing Up Milk 3, 600g (4bx/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
Same manufacturer · 3CS ORGANICS LLC
See all →- ModerateHIPP Anti-Reflux Infant Formula Recalled for Lack of FDA Approval
FDA (Food) · 2017-07-19
- Moderate3CS Organics Recalls Lebenswert Infant and Toddler Milk Formulas
FDA (Food) · 2017-07-19
- ModerateHIPP Infant Formula Recalled for Lack of FDA Approval and English Labels
FDA (Food) · 2017-07-19
- Moderate3CS Organics Recalls HIPP Bio Combiotik Infant Formula for Labeling Issues
FDA (Food) · 2017-07-19
- Moderate3CS Organics Recalls HIPP Organic Infant Milk Products for Labeling Issues
FDA (Food) · 2017-07-19
Same hazard · mis labeling
See all →- SevereImperio Distribution Recalls Beef Jerky Produced Without Federal Inspection
USDA FSIS · 2026-10-24
- SevereBetter Bakehouse Recalls Donutful Chocolate Dipped Vanilla Cake Donuts for Undeclared Milk
FDA (Food) · 2026-10-14
- HighFreshPoint Recalls Cranberry Chicken Salad Wedges for Undeclared Egg Allergen
FDA (Food) · 2026-10-14
- HighJ K Patisserie & Bakery LLC Recalls Croissants for Undeclared Egg
FDA (Food) · 2026-10-14
- LowMindray ePM Series Patient Monitor Manuals Recalled for Alarm Clarification
FDA (Devices) · 2026-10-14
Similar recalls
- ModerateHiPP HA Infant Formula Recalled for Missing Pre-Market Notification
FDA (Food) · 2021-08-25
- ModerateHiPP HA Infant Formula Recalled for Missing FDA Premarket Notification and Labeling
FDA (Food) · 2021-08-25
- SevereHiPP UK Stage 2 Infant Formula Recalled for Missing FDA Notifications and Improper Labeling
FDA (Food) · 2021-08-25
- SevereHiPP Dutch Stage 2 Infant Formula Missing Pre-Market Approval and Labeling
FDA (Food) · 2021-08-25
- HighHiPP German Stage 2 Infant Formula Lacks Required FDA Pre-Market Approval and Labeling
FDA (Food) · 2021-08-25
- SevereHiPP HA Infant Formula Recalled for Inadequate Iron and Missing Labeling
FDA (Food) · 2021-08-25