HiPP UK Stage 2 Infant Formula Recalled for Missing FDA Notifications and Improper Labeling
Able Groupe Inc is recalling HiPP UK Stage 2 Combiotic Follow-On Infant Milk Formula because required pre-market FDA notifications were not submitted and products lack mandatory English-language labeling as required by federal regulations.
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 with missing pre-market notifications and non-compliant labeling. The product lacks mandatory English-language labeling and regulatory approval, creating a significant safety and regulatory compliance risk for vulnerable consumers (infants). Although no illness or injury has been reported, the regulatory violations and non-compliance with infant formula safety requirements qualify this as Severe under the rubric.
Plain-English summary
Able Groupe Inc is recalling approximately 76,000 units of HiPP UK Stage 2 Combiotic Follow-On Infant Milk Formula. The products were distributed directly through the firm's website at littlebundle.com.
The recall was initiated because the required pre-market notifications for these infant formulas were not submitted to the FDA. Additionally, all products are not labeled as required by 21 CFR 107.10 and 107.20 and do not bear mandatory labeling statements in English.
Consumers who have purchased this product are advised to contact Able Groupe Inc or check the FDA website for further instructions regarding their purchased units.
The recalled product
- Product
- HiPP UK 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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