Holle Bio Stage PRE Organic Infant Milk Formula
⚠ Critical Alert — Stop Using Immediately
This product has been flagged with severe risks (undeclared allergen). Stop using it now and contact the brand or FDA for a refund, repair, or replacement.
FDA Recall Notice
Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-F-0917-2021.
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 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.
Corrective Action (per FDA)
Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-F-0917-2021.
Recall terminated by FDA.
✅ What you should do
- Stop using the product if you own it.
- Check the model number, lot code, or sell-by date against the recall notice above.
- Contact Able Groupe Inc or the retailer where you bought it for a refund, replacement, or repair.
- For the most current official instructions, visit the FDA recall page.
- If you've been hurt by this product, report the incident to FDA.
Consumer Contact (per FDA)
Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-F-0917-2021.
Able Groupe Inc
About the U.S. Food and Drug Administration
The FDA regulates drugs, medical devices, food, cosmetics, and tobacco. Adverse event reports and recall notices are the main public safety signal.
Visit FDA.gov →📣 Report a food, supplement, or cosmetic problem to the FDA
If you had a reaction, found contamination, or experienced a labeling problem with this product, report it to the FDA. The agency uses consumer reports to track emerging safety signals and trigger recalls.
Able Groupe Inc Recall FAQ
Able Groupe Inc is the subject of a dairy safety report: Holle Bio Stage PRE Organic Infant Milk Formula. The notice was published on August 8, 2021 by the U.S. Food and Drug Administration (FDA). Approximately 76,000 units are potentially affected.