3CS Organics Recalls Unapproved Holle Goat Milk Infant Formula
3CS Organics LLC is recalling Holle goat milk infant formula products that are not FDA approved and lack English labeling.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves infant formula, a high-risk product for vulnerable populations, and the products are not FDA approved. While no specific illnesses are reported, the lack of approval and labeling issues for infant nutrition constitute a significant risk of harm, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
3CS Organics LLC is recalling specific Holle goat milk-based infant and follow-up formula products. The recall involves 25,000 boxes of various Holle Bio formulas, including infant milk and follow-up milk in 400g and 600g sizes.
The FDA issued this recall because the products are not FDA approved and not all products are labeled in English. The distribution pattern indicates the products were available nationwide in the United States, as well as in Canada, France, Israel, and Mexico. All lots are affected.
Consumers should stop using the recalled products immediately. The source text does not specify a specific consumer action such as returning the product or obtaining a refund, but standard recall procedures generally involve ceasing use and contacting the manufacturer or retailer for instructions.
The recalled product
- Product
- HOLLE Bio Lait Pour Nourrissons Au Lait De Chevre, Zuigelingenmelk OP Geitenmelbasis, 1, 400g (4/case), HOLLE Bio-Flogemilch Auf Ziegenmilchbasis, 1, 400g (4/case), HOLLE Bio-Folgenmilch Auf Ziegenmilchbasis, 3, 400g (4/case), HOLLE Bio-Folgemich, 2, 600g (3bx/case), HOLLE Bio-Fo
- 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.
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