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.
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 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…
- 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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