HiPP German Stage 2 Infant Formula Lacks Required FDA Pre-Market Approval and Labeling
Able Groupe Inc is recalling HiPP German Stage 2 Combiotic Follow-on Infant Milk Formula because it was not submitted for required FDA pre-market notification and lacks mandatory English labeling statements.
The agency’s classification
FDA (Food): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This recall involves an unapproved infant formula without required FDA pre-market notification or proper labeling. Infant formula is a high-risk product category where regulatory non-compliance creates significant potential for harm, even though no illnesses or injuries have been reported.
Plain-English summary
Able Groupe Inc is recalling approximately 76,000 units of HiPP German Stage 2 Combiotic Follow-on Infant Milk Formula. The recall affects all product codes.
The company failed to submit required pre-market notifications to the FDA for these infant formulas. Additionally, the products are not labeled as required by 21 CFR 107.10 and 107.20, and do not bear mandatory labeling statements in English.
The affected products were sold directly from the firm's website, littlebundle.com. Consumers who have purchased this product should discontinue use and contact the manufacturer or consult their pediatrician regarding safe feeding alternatives for their infants.
The recalled product
- Product
- HiPP German Stage 2 Combiotic 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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