HiPP Comfort Milk Formula

Able Groupe INC recalled HiPP Comfort Milk Formula in a Class I action — the FDA's most serious tier, reserved for products with a reasonable probability of causing serious health consequences or death on Aug 8, 2021.

The FDA-published reason for this recall 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."

Distribution was limited; the FDA record lists "All sales are direct from firm website - littlebundle.com." Single-area recalls still warrant a kitchen check for anyone who shops within that footprint. The recalling firm is based in Sparks, NV. The recall covers 76,000 units total of product. The FDA has Terminated this recall (first reported Aug 25, 2021), its final lifecycle state, indicating the agency considers the corrective action resolved. The historical record remains useful for tracking a brand's recall pattern over time.