Key Takeaway
Holle Bio Stage PRE Organic Infant Milk Formula by Able Groupe Inc was recalled on August 8, 2021. The hazard: The required pre-market notifications for these new infant formulas have not been submitted to the FDA. Some products contain less than 1 milligram o...
Holle Bio Stage PRE Organic Infant Milk Formula
Description
Holle Bio Stage PRE Organic Infant Milk Formula
Hazard / 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 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.
Class I: Dangerous or defective product that could cause serious health problems or death.
Class I is the most serious recall classification used by the FDA, indicating a reasonable probability of serious health consequences or death.
Products Affected
Company Information
Able Groupe Inc
Sparks, NV, United States
View all 21 recalls by Able Groupe Inc →Distribution
All sales are direct from firm website - littlebundle.com
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Frequently Asked Questions
Is this recall still active?
Check the status badge at the top of this page. "Ongoing" means the recall is still active and you should follow the remedy instructions. "Completed" or "Terminated" means the recall process has concluded, though the safety issue remains relevant for any unrepaired products.
How do I check if my product is affected?
Compare the model number, lot code, serial number, or date range listed in the recall notice with the information on your product's label or packaging. For vehicles, check your VIN at NHTSA.gov/Recalls.
What remedy is available for this recall?
Check the remedy section above or contact the manufacturer directly for current remedy options.
Where can I find the original recall notice?
This recall was issued by FDA Food. Visit the agency's official website for the original notice.