The Recall Desk
ModerateFDA (Food)·F-0920-2021·Announced 2021-08-25

Holle Goat Stage 2 Infant Formula Recalled for Missing FDA Pre-Market Notification

Able Groupe Inc is recalling Holle Goat Stage 2 Organic Follow-On Infant Milk Formula (76,000 units) because required pre-market notifications were not submitted to the FDA and products lack mandatory labeling in English.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: This is an FDA Class II recall involving regulatory non-compliance (missing pre-market notification and labeling deficiencies). There are no reported illnesses, injuries, or confirmed health hazards described in the source text. The violations are labeling and administrative in nature rather than direct product contamination or safety defect.

Plain-English summary

Able Groupe Inc is recalling Holle Goat Stage 2 Organic Follow-On Infant Milk Formula distributed exclusively through littlebundle.com. The company did not submit required pre-market notifications to the FDA before marketing these infant formulas.

Additionally, the products do not comply with federal labeling requirements under 21 CFR 107.10 and 107.20. The formulas do not bear mandatory labeling statements in English as required by law.

Consumers who have purchased this product should contact the manufacturer or refer to the FDA website for further guidance on what actions to take.

The recalled product

Product
Holle Goat Stage 2 Organic Follow-On Infant Milk Formula
Manufacturer
Able Groupe Inc
Category
Food — Infant Formula
Hazard
  • regulatory-non-compliance
  • missing-labeling

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.

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