HiPP Comfort Milk Formula
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 adequate iron for some…
Holle Bio Stage PRE Organic Infant Milk Formula recall
Recalled by Able Groupe Inc · Sparks, NV, United States
Class I — High risk. Reasonable probability of serious harm or death.
Why it was 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.
A label that does not match the product can hide an ingredient someone must avoid, or show a wrong use-by date. All labeling errors recalls.
What was recalled
Holle Bio Stage PRE Organic Infant Milk Formula
Quantity: 76,000 units total
Lot codes, dates and UPCs
A recall covers only these codes. Compare them with the lot number, best-by date or UPC printed on your package.
All codes
Where it was sold
FDA's distribution note: All sales are direct from firm website - littlebundle.com
Do not eat it. Class I means FDA judged there is a reasonable probability of serious illness or death. If the brand, size and lot or date code on your package match, throw the product away or return it to the store for a refund, and clean any surface or container it touched. If anyone has eaten it and feels unwell, contact a doctor and mention the recall. FDA lists this recall as terminated: the company has finished removing the product, so it should no longer be on shelves - but it can still be in a freezer or pantry.
- Recalling firm
- Able Groupe Inc
- Initiated by
- Voluntary: Firm initiated
- Recall initiated
- Aug 8, 2021
- In FDA report of
- Aug 25, 2021
- Terminated
- Sep 8, 2021
- FDA recall number
- F-0917-2021 · event 88432
- Official record
- FDA enforcement report search
Also recalled with it (20 more products)
FDA files each product of one recall action separately; these share the same FDA event.
HiPP AR Germany Anti-Reflux Milk Formula
Reason The required pre-market notifications for these new infant formulas have not been submitted to the FDA. All products are not labeled as required by 21 CFR 107 .10 and 107.20 and do not bear mandatory labeling…
HiPP Dutch Stage 1 Combiotic Infant Milk Formula
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 adequate iron for some…
HiPP HA Germany Hypoallergenic Stage PRE Combiotic Infant Milk Formula
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 adequate iron for some…
HiPP Dutch Stage 2 Combiotic Follow-on Milk Formula
Reason The required pre-market notifications for these new infant formulas have not been submitted to the FDA. All products are not labeled as required by 21 CFR 107 .10 and 107.20 and do not bear mandatory labeling…
HiPP HA Germany Hypoallergenic Stage 1 Combiotic Infant Milk Formula
Reason The required pre-market notifications for these new infant formulas have not been submitted to the FDA. All products are not labeled as required by 21 CFR 107 .10 and 107.20 and do not bear mandatory labeling…
HiPP HA Germany Hypoallergenic Stage 2 Combiotic Follow-On Infant…
Reason The required pre-market notifications for these new infant formulas have not been submitted to the FDA. All products are not labeled as required by 21 CFR 107 .10 and 107.20 and do not bear mandatory labeling…
HiPP German Stage 1 Combiotic Infant Milk Formula
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 adequate iron for some…
HiPP German Stage 2 Combiotic Follow-on Infant Milk Formula
Reason The required pre-market notifications for these new infant formulas have not been submitted to the FDA. All products are not labeled as required by 21 CFR 107 .10 and 107.20 and do not bear mandatory labeling…
Holle Bio Stage 1 Organic Infant Milk Formula
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 adequate iron for some…
Holle Bio Stage 2 Organic Follow-On Infant Milk Formula
Reason The required pre-market notifications for these new infant formulas have not been submitted to the FDA. All products are not labeled as required by 21 CFR 107 .10 and 107.20 and do not bear mandatory labeling…
Holle Goat Stage 1 Organic Infant Milk Formula
Reason The required pre-market notifications for these new infant formulas have not been submitted to the FDA. All products are not labeled as required by 21 CFR 107 .10 and 107.20 and do not bear mandatory labeling…
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