Lebenswert Stage 2 Infant Formula Recalled for Missing Labeling
Able Groupe Inc is recalling Lebenswert Folgemilch Stage 2 Organic Follow-On Infant Milk Formula (76,000 units) sold directly through littlebundle.com. The formula was not submitted for required FDA pre-market notification and lacks mandatory English-language labeling.
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 recall is classified as FDA Class II and involves an infant formula product where pre-market notifications were not submitted and mandatory labeling is absent. Infant formula is a high-risk product category where labeling failures and lack of regulatory oversight create significant potential for harm to vulnerable infants, meeting the Severe threshold.
Plain-English summary
Able Groupe Inc is recalling all lots of Lebenswert Folgemilch Stage 2 Organic Follow-On Infant Milk Formula, totaling 76,000 units. The formula was distributed exclusively through direct sales on the firm's website at littlebundle.com.
The recall is being issued because the required pre-market notification for this new infant formula was not submitted to the FDA. Additionally, the product is not labeled as required by 21 CFR 107.10 and 107.20, and does not bear mandatory labeling statements in English.
Consumers who have purchased this product should discontinue use. Consumers with questions should contact the recalling firm, Able Groupe Inc.
The recalled product
- Product
- Lebenswert Folgemilch 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
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Same hazard · missing pre market notification
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