Comfort Milk Formula (HiPP) – FDA Notification Missing (2021)
Class I: A situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death
Class I recall indicates potential for serious health consequences.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
HiPP Comfort Milk Formula
Brand
Able Groupe Inc
Lot Codes / Batch Numbers
All codes.
Products Sold
All codes.
Able Groupe Inc is recalling HiPP Comfort Milk Formula due to The required pre-market notifications for these new infant formulas have not been submitted to the FDA. Some products contain less than 1 milligram o. This is a Class I recall, indicating a high risk of serious health consequences. Based on FDA enforcement report.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
Consumers should stop using the product and contact the recalling firm or return it to the place of purchase.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 6, 2026