HiPP UK Stage 1 Infant Milk Formula Lacks Required FDA Approval
Able Groupe Inc is recalling HiPP UK Stage 1 Combiotic First Infant Milk Formula because required pre-market FDA notifications were not submitted. Some products contain insufficient iron and lack mandatory labeling.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: This is an FDA Class I recall involving an infant formula product with potential nutritional inadequacy (insufficient iron) and failure to comply with mandatory labeling requirements. Infant formulas are high-risk products where nutritional deficiencies can cause serious harm in vulnerable populations, particularly premature infants and those with existing health vulnerabilities.
Plain-English summary
Able Groupe Inc is recalling all codes of HiPP UK Stage 1 Combiotic First Infant Milk Formula (76,000 units total) distributed directly through littlebundle.com. The required pre-market notifications for these infant formulas have not been submitted to the FDA, and the products do not comply with federal labeling requirements.
Some products contain less than 1 milligram of iron per 100 Calories, which may not provide adequate iron for certain infants, particularly those born prematurely or with low birth weight, those with low iron levels at birth, or those at risk for iron deficiency due to illness. 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. Consult a healthcare provider if your infant has consumed this formula.
The recalled product
- Product
- HiPP UK Stage 1 Combiotic First Infant Milk Formula
- Manufacturer
- Able Groupe Inc
- Category
- Food — Infant Formula
- Hazard
- inadequate-iron
- mis-labeling
- unapproved-product
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.
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