Holle Bio Stage 2 Organic Infant Formula Lacks Required FDA Pre-Market Notification
Able Groupe Inc is recalling Holle Bio Stage 2 Organic Follow-On Infant Milk Formula because required FDA pre-market notifications were not submitted and the product lacks mandatory labeling in English required by federal regulations.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: This is an FDA Class II recall involving an infant formula—a high-risk product category for vulnerable populations—lacking pre-market notification and required labeling. Although no reported illnesses or injuries are stated, the regulatory violations and product category elevate this to Severe per the rubric criterion for significant risk-of-harm products in Class II recalls.
Plain-English summary
Able Groupe Inc is recalling Holle Bio Stage 2 Organic Follow-On Infant Milk Formula (76,000 units total) due to regulatory violations. The products do not have the required FDA pre-market notifications and lack mandatory labeling statements in English as required by 21 CFR 107.10 and 107.20.
The product was sold directly through the firm's website at littlebundle.com. All codes of this product are affected by this recall.
Consumers who have purchased this formula should stop using it immediately and contact Able Groupe Inc through littlebundle.com for further instructions.
The recalled product
- Product
- Holle Bio Stage 2 Organic Follow-On Infant Milk Formula
- Manufacturer
- Able Groupe Inc
- Category
- Food — Infant Formula
- Affected units
- 76,000
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- All codes
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 21 recalled by Able Groupe Inc under a single FDA (Food) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 21 products in this recall →Related recalls
Same manufacturer · Able Groupe Inc
See all →- SevereHiPP UK Stage 1 Infant Milk Formula Lacks Required FDA Approval
FDA (Food) · 2021-08-25
- HighKendamil Organic Stage 2 Infant Formula Recalled for Missing Labeling
FDA (Food) · 2021-08-25
- HighHolle Goat Stage 1 Organic Infant Milk Formula Recalled for Labeling Violations
FDA (Food) · 2021-08-25
- SevereHiPP Comfort Milk Formula Recalled for Inadequate Iron and Labeling Violations
FDA (Food) · 2021-08-25
- SevereLebenswert Anfangsmilch Stage 1 Infant Formula Recall for Inadequate Iron and Labeling
FDA (Food) · 2021-08-25
Same hazard · missing pre market notification
See all →- SevereHiPP Dutch Stage 2 Infant Formula Missing Pre-Market Approval and Labeling
FDA (Food) · 2021-08-25
- SevereLebenswert Folgemilch Stage 3 Organic Toddler Formula Recalled
FDA (Food) · 2021-08-25
- SevereLebenswert Stage 2 Infant Formula Recalled for Missing Labeling
FDA (Food) · 2021-08-25