Reported Aug 25, 2021 · Terminated
Holle Bio Stage PRE Organic Infant Milk Formula
Able Groupe Inc.
High riskUsing this product could cause serious injury, illness or death — stop using it now.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Able Groupe Inc · 1486 Kleppe Ln · Sparks, NV · 89431-6428
Is this the product you have?
- Holle Bio Stage PRE Organic Infant Milk Formula
- Lot codes and dates
- All codes
- Amount recalled
- 76,000 units total
This recall covers 21 products
The agency filed one notice per product. You are reading one of them; the other 20 are below.
8 more are in the archive.
Why it was recalled
Stop using this product now
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.
Using this product could cause serious injury, illness or death — stop using it now.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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