Holle Bio Stage PRE Organic Infant Milk Formula Recall for Inadequate Iron and Labeling Defects
Able Groupe Inc is recalling Holle Bio Stage PRE Organic Infant Milk Formula because the products were not submitted for FDA pre-market approval, contain potentially inadequate iron levels, and lack required labeling in English.
The agency’s classification
FDA (Food): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: This recall is classified FDA Class I by the agency. The source text indicates risk of nutritional inadequacy (iron deficiency) in vulnerable populations (premature infants, low birth weight infants, infants with existing low iron levels), which falls under the Severe category criterion of risk-of-harm products where injury has not yet been reported, and Class I classification never goes below score 4.
Plain-English summary
Able Groupe Inc is recalling Holle Bio Stage PRE Organic Infant Milk Formula across all product codes. The recall affects approximately 76,000 units sold directly through the firm's website at littlebundle.com.
The products were not submitted for required FDA pre-market notification. Additionally, some products contain less than 1 milligram of iron per 100 Calories, which may not provide adequate iron for certain infants, particularly those born prematurely, with low birth weight, with low iron levels at birth, or at risk for iron deficiency due to illness. The products are not labeled as required by federal regulations 21 CFR 107.10 and 107.20 and do not bear mandatory labeling statements in English.
Consumers who have purchased this product should stop using it and contact Able Groupe Inc or consult a healthcare provider for guidance.
The recalled product
- Product
- Holle Bio Stage PRE Organic 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
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- SevereHiPP Dutch Stage 2 Infant Formula Missing Pre-Market Approval and Labeling
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