HiPP Dutch Stage 2 Infant Formula Missing Pre-Market Approval and Labeling
Able Groupe Inc is recalling HiPP Dutch Stage 2 Combiotic Follow-on Milk Formula because required pre-market notifications were not submitted to the FDA and products lack 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 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 is an FDA Class II recall involving infant formula—a high-risk product for vulnerable populations—distributed without required pre-market approval and with non-compliant labeling. The violation of mandatory safety labeling and regulatory pre-market notification requirements for infant formula meets the threshold for Severe severity.
Plain-English summary
Able Groupe Inc is recalling HiPP Dutch Stage 2 Combiotic Follow-on Milk Formula (approximately 76,000 units) because the required pre-market notifications for these infant formulas have not been submitted to the FDA. All products are not labeled as required by federal regulations 21 CFR 107.10 and 107.20, and do not bear the mandatory labeling statements in English.
The recalled products were sold directly through the firm's website at littlebundle.com. Consumers who purchased this infant formula should stop using it and contact the recalling firm for instructions on return or disposal.
This recall affects the safety and regulatory compliance of infant formula, which is a critical food product for vulnerable populations. Consumers with questions should reach out to Able Groupe Inc or the FDA for further guidance.
The recalled product
- Product
- HiPP Dutch Stage 2 Combiotic Follow-on 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.
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