The Recall Desk
HighFDA (Food)·F-0927-2021·Announced 2021-08-25

Kendamil Organic Stage 2 Infant Formula Recalled for Missing Labeling

Able Groupe Inc is recalling Kendamil Organic Stage 2 Follow on Milk Formula because required pre-market FDA notifications were not submitted and labeling does not comply with federal requirements.

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 is a Class II FDA recall of an infant formula involving regulatory violations and labeling non-compliance. While no illness or injury has been reported, infant formula is a high-risk product category where labeling compliance and pre-market clearance directly protect consumer safety, particularly for vulnerable populations.

Plain-English summary

Able Groupe Inc is recalling Kendamil Organic Stage 2 Follow on Milk Formula due to regulatory compliance failures. The company did not submit required pre-market notifications to the FDA, as mandated for new infant formulas.

Additionally, all products are not labeled as required by 21 CFR 107.10 and 107.20. The products do not bear mandatory labeling statements in English, which is a federal requirement.

The affected product was distributed directly to consumers through the firm's website at littlebundle.com. A total of 76,000 units have been distributed. Consumers who have purchased this product should contact the firm or consult with their pediatrician regarding alternative feeding options.

The recalled product

Product
Kendamil Organic Stage 2 Follow on Milk Formula
Manufacturer
Able Groupe Inc
Category
Food — Infant Formula
Hazard
  • missing-labeling
  • regulatory-non-compliance
  • 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.

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