Holle Goat Stage 2 Infant Formula Recalled for Missing FDA Pre-Market Notification
Able Groupe Inc is recalling Holle Goat Stage 2 Organic Follow-On Infant Milk Formula (76,000 units) because required pre-market notifications were not submitted to the FDA and products lack mandatory labeling in English.
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: This is an FDA Class II recall involving regulatory non-compliance (missing pre-market notification and labeling deficiencies). There are no reported illnesses, injuries, or confirmed health hazards described in the source text. The violations are labeling and administrative in nature rather than direct product contamination or safety defect.
Plain-English summary
Able Groupe Inc is recalling Holle Goat Stage 2 Organic Follow-On Infant Milk Formula distributed exclusively through littlebundle.com. The company did not submit required pre-market notifications to the FDA before marketing these infant formulas.
Additionally, the products do not comply with federal labeling requirements under 21 CFR 107.10 and 107.20. The formulas do not bear mandatory labeling statements in English as required by law.
Consumers who have purchased this product should contact the manufacturer or refer to the FDA website for further guidance on what actions to take.
The recalled product
- Product
- Holle Goat Stage 2 Organic Follow-On Infant Milk Formula
- Manufacturer
- Able Groupe Inc
- Category
- Food — Infant Formula
- Affected units
- 76,000
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 codes
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 21 recalled by Able Groupe Inc 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 21 products in this recall →Related recalls
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