HiPP HA Infant Formula Recalled for Missing Pre-Market Notification
Able Groupe Inc is recalling HiPP HA Germany Hypoallergenic Stage 1 Combiotic Infant Milk Formula because required pre-market notifications were not submitted to the FDA and products lack mandatory 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: This is an FDA Class II recall. The source text does not report any illnesses, injuries, or deaths. The hazard is non-compliance with pre-market notification and labeling requirements rather than a confirmed product defect or contamination. No actual harm has been reported.
Plain-English summary
Able Groupe Inc is recalling approximately 76,000 units of HiPP HA Germany Hypoallergenic Stage 1 Combiotic Infant Milk Formula sold directly through littlebundle.com.
The recall was issued because required pre-market notifications for these new infant formulas were not submitted to the FDA. Additionally, all products are not labeled as required by 21 CFR 107.10 and 107.20 and do not bear mandatory labeling statements in English.
Consumers who have purchased this product should not use it and should contact the firm for further instructions. Infant formulas sold in the United States must comply with FDA pre-market notification requirements and labeling standards.
The recalled product
- Product
- HiPP HA Germany Hypoallergenic Stage 1 Combiotic 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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