HiPP AR Germany Anti-Reflux Infant Formula Lacks Required FDA Approval and Labeling
Able Groupe Inc is recalling HiPP AR Germany Anti-Reflux Milk Formula because required pre-market FDA notifications were not submitted and products lack mandatory English labeling 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 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 is an FDA Class II recall involving an infant formula product with missing pre-market notifications and non-compliant labeling. Infant formulas are high-risk products where regulatory compliance directly protects consumer safety, and the absence of required FDA review and English labeling statements presents a risk of harm to vulnerable populations, even though no illnesses are reported in the source text.
Plain-English summary
Able Groupe Inc is recalling HiPP AR Germany Anti-Reflux Milk Formula distributed through its website littlebundle.com. The recall affects approximately 76,000 units across all product codes.
The product is being recalled because required pre-market notifications for the infant formula have not been 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 should not use it. Contact the firm through littlebundle.com for further instructions regarding this recall.
The recalled product
- Product
- HiPP AR Germany Anti-Reflux 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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