The Recall Desk
SevereFDA (Food)·F-0918-2021·Announced 2021-08-25

Holle Bio Stage 2 Organic Infant Formula Lacks Required FDA Pre-Market Notification

Able Groupe Inc is recalling Holle Bio Stage 2 Organic Follow-On Infant Milk Formula because required FDA pre-market notifications were not submitted and the product lacks mandatory labeling in English required by federal regulations.

What this means for you

Illness, injury, or structural failure has been reported. 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 an infant formula—a high-risk product category for vulnerable populations—lacking pre-market notification and required labeling. Although no reported illnesses or injuries are stated, the regulatory violations and product category elevate this to Severe per the rubric criterion for significant risk-of-harm products in Class II recalls.

Plain-English summary

Able Groupe Inc is recalling Holle Bio Stage 2 Organic Follow-On Infant Milk Formula (76,000 units total) due to regulatory violations. The products do not have the required FDA pre-market notifications and lack mandatory labeling statements in English as required by 21 CFR 107.10 and 107.20.

The product was sold directly through the firm's website at littlebundle.com. All codes of this product are affected by this recall.

Consumers who have purchased this formula should stop using it immediately and contact Able Groupe Inc through littlebundle.com for further instructions.

The recalled product

Product
Holle Bio Stage 2 Organic Follow-On Infant Milk Formula
Manufacturer
Able Groupe Inc
Category
Food — Infant Formula
Hazard
  • missing-pre-market-notification
  • mis-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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