Recall Radar

Able Groupe recalls Lebenswert Anfangsmilch Stage 1 Organic Infant Milk Formula and 20 more: label issue

August 25, 2021 · Able Groupe Class I

Class IFDA’s highest-risk class: a reasonable probability that using or being exposed to the product will cause serious adverse health consequences or death.
Reason for the recallThe 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.

Find the official FDA enforcement report

Recall at a glance

Recalling company
Able Groupe
Location
Sparks, NV
Reported by FDA
August 25, 2021
Recall started
August 8, 2021
Risk class
Class I
Status (latest data we have)
Terminated
Type
Voluntary: Firm initiated
Category
Supplements and infant formula
Reason type
Labeling and quality

Is my product affected?

Compare your product’s name, size and lot or date codes with the list below. A recall usually covers only specific codes.

  • Lebenswert Anfangsmilch Stage 1 Organic Infant Milk Formula
    Quantity: 76,000 units total
    Codes: All codes
  • HiPP HA Germany Hypoallergenic Stage 1 Combiotic Infant Milk Formula
    Quantity: 76,000 units total
    Codes: All codes
  • Holle Goat Stage 1 Organic Infant Milk Formula
    Quantity: 76,000 units total
    Codes: All codes
  • HiPP Comfort Milk Formula
    Quantity: 76,000 units total
    Codes: All codes.
  • HiPP HA Germany Hypoallergenic Stage PRE Combiotic Infant Milk Formula
    Quantity: 76,000 units total
    Codes: All codes
  • HiPP Dutch Stage 2 Combiotic Follow-on Milk Formula
    Quantity: 76,000 units total
    Codes: All codes
  • Lebenswert Folgemilch Stage 3 Organic Toddler Formula
    Quantity: 76,000 units total
    Codes: All codes
  • Holle Bio Stage 2 Organic Follow-On Infant Milk Formula
    Quantity: 76,000 units total
    Codes: All codes
  • Kendamil Organic Stage 2 Follow on Milk Formula
    Quantity: 76,000 units total
    Codes: All codes
  • Holle Goat Stage 2 Organic Follow-On Infant Milk Formula
    Quantity: 76,000 units total
    Codes: All codes
  • HiPP HA Germany Hypoallergenic Stage 2 Combiotic Follow-On Infant Milk Formula
    Quantity: 76,000 units total
    Codes: All codes
  • Holle Bio Stage 1 Organic Infant Milk Formula
    Quantity: 76,000 units total
    Codes: All codes
  • HiPP UK Stage 2 Combiotic Follow-On Infant Milk Formula
    Quantity: 76,000 units total
    Codes: All codes
  • Holle Bio Stage PRE Organic Infant Milk Formula
    Quantity: 76,000 units total
    Codes: All codes
  • HiPP German Stage 1 Combiotic Infant Milk Formula
    Quantity: 76,000 units total
    Codes: All codes
  • Lebenswert Folgemilch Stage 2 Organic Follow-On Infant Milk Formula
    Quantity: 76,000 units total
    Codes: All codes
  • HiPP AR Germany Anti-Reflux Milk Formula
    Quantity: 76,000 units total
    Codes: All codes
  • HiPP UK Stage 1 Combiotic First Infant Milk Formula
    Quantity: 76,000 units total
    Codes: All codes
  • Kendamil Organic Stage 1 First Infant Milk Formula
    Quantity: 76,000 units total
    Codes: All codes
  • HiPP German Stage 2 Combiotic Follow-on Infant Milk Formula
    Quantity: 76,000 units total
    Codes: All codes
  • HiPP Dutch Stage 1 Combiotic Infant Milk Formula
    Quantity: 76,000 units total
    Codes: All codes

Where it was distributed

All sales are direct from firm website - littlebundle.com

What to do

If you have this product, check the codes above. FDA recall notices often tell consumers to stop eating the product and to return it or throw it away. Follow the company’s instructions and the official FDA information, and if you are unsure, do not eat it. If someone becomes ill after eating a recalled food, contact a healthcare professional. See FDA’s recalls and safety alerts for company announcements.

Frequently asked questions

What was recalled?

Able Groupe recalled 21 products, including Lebenswert Anfangsmilch Stage 1 Organic Infant Milk Formula.

Why was it recalled?

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.

What does Class I mean?

FDA’s highest-risk class: a reasonable probability that using or being exposed to the product will cause serious adverse health consequences or death.

Where was it sold or shipped?

All sales are direct from firm website - littlebundle.com

What should I do if I have this product?

Compare the product name, size and lot or date codes with the details on this page. FDA recall notices often tell you to stop eating the product and to return it or throw it away. Follow the company’s instructions and the official FDA information. If you are unsure, do not eat it.

Similar recalls in supplements and infant formula

Sources

Data provided by the U.S. Food and Drug Administration (FDA) through openFDA, shown as published and not validated by this site. This site is independent and is not affiliated with or endorsed by FDA. It covers FDA-regulated foods; meat, poultry and egg products are regulated by USDA. Do not rely on this site for medical decisions: for health concerns contact a healthcare professional, and always follow the official notice and the company’s instructions. Terms and disclaimer.