The Recall Desk
HighFDA (Food)·F-0915-2021·Announced 2021-08-25

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.

What this means for you

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
Hazard
  • regulatory-non-compliance
  • missing-labeling
  • unapproved-formula

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.

Related recalls

Same category