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.
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, 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
Same manufacturer · 3CS ORGANICS LLC
See all →- 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 Infant Formula Due to 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 · regulatory non compliance
See all →- ModerateMedline 10mL Polycarbonate Colored Syringes in Convenience Kits Recalled
FDA (Devices) · 2026-07-01
- ModerateMedline 10mL Polycarbonate Colored Syringes Convenience Kits Recalled
FDA (Devices) · 2026-07-01
- SevereMedline 10mL Polycarbonate Syringes in Medical Procedure Kits Recalled
FDA (Devices) · 2026-07-01
- ModerateMedline Polycarbonate Syringes Recalled for Unapproved Design Changes
FDA (Devices) · 2026-07-01
- SevereMedline polycarbonate syringes recalled for unapproved design changes
FDA (Devices) · 2026-07-01