[Recalled] HiPP HA Germany Hypoallergenic Stage PRE Combiotic Infant Milk Formula — The required pre-market notifications for these new infant formulas have not be… | FDA 2021-08-08

The product on this page is subject to an official recall. We summarise the regulator's findings and the recommended action.

Recall details

Why it was recalled

According to the FDA_FOOD notice, the identified hazard is: The required pre-market notifications for these new infant formulas have not been submitted to the FDA. Some products contain less than 1 milligram of iron per 100 Calories and may not provide adequate iron for some infants, particularly infants born prematurely or with a low birth weight, had low iron levels at birth, or are at risk for becoming iron deficient due to illness. All products are not labeled as required by 21 CFR 107 .10 and 107.20 and do not bear mandatory labeling statements in English.

This Class I recall concerns food products distributed in United States and was recorded by FDA_FOOD. Recalls in this category are published so that owners, retailers, and importers can identify affected units and act quickly.

What to do if you own this product

Stop using the product immediately and follow the authority's remedy (return, repair, or disposal).

Read the full official notice →

Related recalls from Able Groupe Inc

• Lebenswert Anfangsmilch Stage 1 Organic Infant Milk Formula — Class I
• HiPP HA Germany Hypoallergenic Stage 1 Combiotic Infant Milk Formula — Class II
• Holle Goat Stage 1 Organic Infant Milk Formula — Class II
• HiPP Comfort Milk Formula — Class I
• HiPP Dutch Stage 2 Combiotic Follow-on Milk Formula — Class II
• Lebenswert Folgemilch Stage 3 Organic Toddler Formula — Class II

This page indexes a public government recall notice for reference. We do not sell or verify this product; always confirm the current status on the authority's official site.