Agency classClass IOur severity:Severe FDA (Food)·F-0907-2021·Announced 2021-08-25

HiPP Comfort Milk Formula Recalled for Inadequate Iron and Labeling Violations

Able Groupe Inc is recalling HiPP Comfort Milk Formula because some products contain insufficient iron and lack required labeling. The formula may not provide adequate iron for certain infants, particularly premature or low-birth-weight infants.

The agency’s classification

FDA (Food): Class I

Class I is 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.

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 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The FDA classified this as a Class I recall. The hazard—inadequate iron in infant formula—directly affects a vulnerable population (infants, particularly premature and low-birth-weight infants) at risk for serious developmental and health consequences from iron deficiency. Although no illnesses are reported in the source text, Class I classification mandates a minimum score of 4 per the rubric.

Plain-English summary

Able Groupe Inc is recalling all codes of HiPP Comfort Milk Formula sold directly through littlebundle.com. The recall involves approximately 76,000 units total.

The products were distributed without required pre-market notifications to the FDA. 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, with low birth weight, with low iron levels at birth, or at risk for iron deficiency due to illness.

Additionally, all recalled products are not labeled as required by FDA regulations (21 CFR 107.10 and 107.20) and do not bear mandatory labeling statements in English.

Consumers who have purchased this formula should stop use and may contact Able Groupe Inc through littlebundle.com for further instructions.

The recalled product

Product: HiPP Comfort Milk Formula
Manufacturer: Able Groupe Inc
Category: Food — Infant Formula
Hazard: inadequate-iron
mis-labeling
unlabeled-product
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 →

Same manufacturer · Able Groupe Inc

See all →

Severe
HiPP UK Stage 1 Infant Milk Formula Lacks Required FDA Approval
FDA (Food) · 2021-08-25
High
Kendamil Organic Stage 2 Infant Formula Recalled for Missing Labeling
FDA (Food) · 2021-08-25
High
Holle Goat Stage 1 Organic Infant Milk Formula Recalled for Labeling Violations
FDA (Food) · 2021-08-25
Severe
Lebenswert Anfangsmilch Stage 1 Infant Formula Recall for Inadequate Iron and Labeling
FDA (Food) · 2021-08-25
Severe
HiPP Dutch Stage 2 Infant Formula Missing Pre-Market Approval and Labeling
FDA (Food) · 2021-08-25

Same hazard · inadequate iron