HOLLE Organic Infant Formula Recalled for Lack of FDA Approval
3CS Organics LLC is recalling HOLLE organic infant formula products because they are not FDA approved and lack 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, which typically involves minor labeling errors or low-risk issues. The source text explicitly cites lack of FDA approval and missing English labeling as the reasons, without reporting any illnesses or injuries.
Plain-English summary
3CS Organics LLC is recalling approximately 25,000 boxes of various HOLLE organic infant formula products. The affected products include HOLLE Bio Zulgelingen Opvolgmelk 2, HOLLE Bio Lait de suite 2, HOLLE Bio Lait pour Nourrissons Zulgelingenmelk, HOLLE Lait Pour Nourrissons 1er Age Bio, HOLLE Bio Lait de Suit Au Lait De Chevre, and HOLLE Bio-Kinermilch 4. The recall covers all lots of these products.
The recall was initiated because the products are not FDA approved and not all products are labeled in English. The products were distributed nationwide in the United States, as well as in Canada, France, Israel, and Mexico.
Consumers who have purchased these products should stop using them and contact the recalling firm for further instructions.
The recalled product
- Product
- HOLLE Bio Zulgelingen Opvolgmelk 2, (3/case), HOLLE Bio Lait de suite, 2, 400g (6/case), HOLLE Bio Lait pour Nourrissons Zulgelingenmelk, 400g (6/case), HOLLE Lait Pour Nourrissons 1er Age Bio, 400g (6/case). HOLLE Bio Lait de Suit Au Lait De Chevre, 400g (6/case) , HOLLE Bio-Ki
- 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 Infant Formula Due to Labeling Issues
FDA (Food) · 2017-07-19
Same hazard · mis labeling
See all →- ModerateMedline Trach Tube Kit Recalled for Component Labeling Discrepancy
FDA (Devices) · 2026-09-02
- ModerateAVID Medical Recalls Halyard Total Joint Kits for Latex Labeling Deficiency
FDA (Devices) · 2026-09-02
- ModerateOlympus Recalls PowerSeal Sealer Due to Incorrect Outer Box Labeling
FDA (Devices) · 2026-09-02
- HighSura Tanmen Ramen Noodles Recalled for Undeclared Fish Allergens
FDA (Food) · 2026-09-02
- SevereWhite Vein Advanced Alkaloids Chewable Tablets Recall for Excess Active Ingredient
FDA (Food) · 2026-09-02