Lebenswert Anfangsmilch Stage 1 Organic Infant Milk Formula
What you need to know
Class I
What happened
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…
Health risk
The product has a reasonable probability of causing serious adverse health consequences or death. A safety issue that does not fit the standard pathogen, allergen, chemical or quality categories.
Action required
Check the identifying codes below and stop using the product. Return it to the retailer for a refund or dispose of it safely, following the recall notice.
Recall closed · classified by the FDADistribution not listedMore food
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All sales are direct from firm website - littlebundle.com
United States
Quantity affected
76, 000 units total
Recall initiation
FDA report date: August 25, 2021
FDA recall number
F-0921-2021
Beyond the headline
The recall, in context
Able Groupe INC initiated this food recall on August 8, 2021. The FDA enforcement report states: 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. The FDA report lists distribution as: All sales are direct from firm website - littlebundle.com.
The FDA enforcement report describes the reason as: 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.
Lebenswert Anfangsmilch Stage 1 Organic Infant Milk Formula was made or distributed by Able Groupe INC in Sparks, NV, United States. This page reflects FDA report F-0921-2021, dated August 25, 2021.
Why this is a Class I recall
Class I means the product has a reasonable probability of causing serious adverse health consequences or death. In this recall, a safety issue that does not fit the standard pathogen, allergen, chemical or quality categories.
FDA definition
The product has a reasonable probability of causing serious adverse health consequences or death.
What to do now
1
Stop using it
Do not eat, drink or take the affected product.
2
Check the codes
Compare the lot and date codes against the table above.
3
Return or discard
Contact the retailer or recalling firm about a refund, and dispose of the product safely.
Consumer safety guide
Product safety recall
Symptoms to watch for
The official enforcement report describes the specific risk. Follow the recall notice, check the product codes and do not use a product that may be affected.
Higher-risk groups
Children, pregnant people, older adults and people with weakened immune systems should take extra care when a product's safety is uncertain.
What to do now
1Stop using or eating the product and keep it away from children and pets.
2Check the UPC and lot/date codes on this page and follow the official recall notice for disposal or return.
3Seek medical advice if anyone develops severe or worrying symptoms after exposure.
Read the official source record for the specific hazard and instructions.
This is general consumer safety information, not medical advice or a diagnosis. Follow the official recall notice and contact a healthcare professional if you have concerns about exposure or symptoms.
Frequently asked
Questions about this recall
4 answers
What is the Lebenswert Anfangsmilch Stage 1 Organic Infant Milk Formula recall?
Able Groupe INC recalled Lebenswert Anfangsmilch Stage 1 Organic Infant Milk Formula in an FDA Class I enforcement action reported as F-0921-2021. 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…
What should I do if I bought this product?
Check the identifying codes below and stop using the product. Return it to the retailer for a refund or dispose of it safely, following the recall notice. Stop using or eating the product and keep it away from children and pets. Check the UPC and lot/date codes on this page and follow the official recall notice for disposal or return. Seek medical advice if anyone develops severe or worrying symptoms after exposure.
Is the Able Groupe INC recall still active?
The FDA lists this recall as recall closed. It remains relevant if you still have the affected product or need to identify a historical recall.
Where can I verify this recall?
This page is normalized from the openFDA enforcement record F-0921-2021. You can verify it directly using the official source link on this page. VerifyRecall updates its index from public FDA enforcement data and does not replace advice from the FDA, the recalling firm or a healthcare professional.
Verify before you act.
VerifyRecall is independent and not affiliated with the FDA. Always confirm the latest status on the official source record.