Food recall

Able Groupe Inc recall: HiPP Comfort Milk Formula

Able Groupe Inc, of Sparks, NV, recalled HiPP Comfort Milk Formula and 20 other products. The FDA's reason: “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...” The FDA classified it Class I: it could cause serious harm or death. The company began the recall voluntarily on August 8, 2021, and the FDA first listed it in its Enforcement Report of August 25, 2021. The FDA has closed the recall: it found the company did all it reasonably could to remove or correct the product.

How serious

Class I

It could cause serious harm or death

Why

Labeling, packaging or manufacturing problems

Status

Terminated

Closed September 8, 2021

The recall

Company
Able Groupe Inc (Sparks, NV)
Reason, in FDA's words
“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.”
Where it was sold
All sales are direct from firm website - littlebundle.com
Recall began
, by the company
FDA classified it
First in an FDA Enforcement Report
FDA event number
88432

The 21 products recalled

As the FDA describes them, with the codes that tell whether a package is part of the recall.

  • F-0907-2021 Class I

    HiPP Comfort Milk Formula

    Codes: All codes.

    Quantity: 76,000 units total

  • F-0908-2021 Class II

    HiPP AR Germany Anti-Reflux Milk Formula

    Codes: All codes

    Quantity: 76,000 units total

  • F-0909-2021 Class I

    HiPP Dutch Stage 1 Combiotic Infant Milk Formula

    Codes: All codes

    Quantity: 76,000 units total

  • F-0910-2021 Class I

    HiPP HA Germany Hypoallergenic Stage PRE Combiotic Infant Milk Formula

    Codes: All codes

    Quantity: 76,000 units total

  • F-0911-2021 Class II

    HiPP Dutch Stage 2 Combiotic Follow-on Milk Formula

    Codes: All codes

    Quantity: 76,000 units total

  • F-0912-2021 Class II

    HiPP HA Germany Hypoallergenic Stage 1 Combiotic Infant Milk Formula

    Codes: All codes

    Quantity: 76,000 units total

  • F-0913-2021 Class II

    HiPP HA Germany Hypoallergenic Stage 2 Combiotic Follow-On Infant Milk Formula

    Codes: All codes

    Quantity: 76,000 units total

  • F-0914-2021 Class I

    HiPP German Stage 1 Combiotic Infant Milk Formula

    Codes: All codes

    Quantity: 76,000 units total

  • F-0915-2021 Class II

    HiPP German Stage 2 Combiotic Follow-on Infant Milk Formula

    Codes: All codes

    Quantity: 76,000 units total

  • F-0916-2021 Class I

    Holle Bio Stage 1 Organic Infant Milk Formula

    Codes: All codes

    Quantity: 76,000 units total

  • F-0917-2021 Class I

    Holle Bio Stage PRE Organic Infant Milk Formula

    Codes: All codes

    Quantity: 76,000 units total

  • F-0918-2021 Class II

    Holle Bio Stage 2 Organic Follow-On Infant Milk Formula

    Codes: All codes

    Quantity: 76,000 units total

  • F-0919-2021 Class II

    Holle Goat Stage 1 Organic Infant Milk Formula

    Codes: All codes

    Quantity: 76,000 units total

  • F-0920-2021 Class II

    Holle Goat Stage 2 Organic Follow-On Infant Milk Formula

    Codes: All codes

    Quantity: 76,000 units total

  • F-0921-2021 Class I

    Lebenswert Anfangsmilch Stage 1 Organic Infant Milk Formula

    Codes: All codes

    Quantity: 76,000 units total

  • F-0922-2021 Class II

    Lebenswert Folgemilch Stage 2 Organic Follow-On Infant Milk Formula

    Codes: All codes

    Quantity: 76,000 units total

  • F-0923-2021 Class II

    Lebenswert Folgemilch Stage 3 Organic Toddler Formula

    Codes: All codes

    Quantity: 76,000 units total

  • F-0924-2021 Class I

    HiPP UK Stage 1 Combiotic First Infant Milk Formula

    Codes: All codes

    Quantity: 76,000 units total

  • F-0925-2021 Class II

    HiPP UK Stage 2 Combiotic Follow-On Infant Milk Formula

    Codes: All codes

    Quantity: 76,000 units total

  • F-0926-2021 Class II

    Kendamil Organic Stage 1 First Infant Milk Formula

    Codes: All codes

    Quantity: 76,000 units total

  • F-0927-2021 Class II

    Kendamil Organic Stage 2 Follow on Milk Formula

    Codes: All codes

    Quantity: 76,000 units total

Get new charts weekly

One email a week with the newest charts and their key numbers. No account needed.

Source and notes

U.S. Food and Drug Administration, Enforcement Reports (openFDA food recall data) (Public domain (U.S. government work); source U.S. Food and Drug Administration, openFDA), data as of August 25, 2021.

Each week the FDA lists the recalls it has classified in its Enforcement Report, often weeks after the company announced the recall, so a month with five weekly reports tends to count more. Each recall counts once, however many products it covers, in the month FDA first listed it. Class I means the food could cause serious harm or death, Class II temporary or minor harm, and Class III is unlikely to harm anyone. Meat, poultry and most egg products are recalled by the U.S. Department of Agriculture, not the FDA, and aren't included. For what to do with a recalled product, see the FDA's recalls page.