The Recall Desk
SevereFDA (Food)·F-0926-2021·Announced 2021-08-25

Kendamil Organic Stage 1 Infant Formula Recalled for Missing FDA Notifications

Able Groupe Inc is recalling Kendamil Organic Stage 1 First Infant Milk Formula because required pre-market FDA notifications were not submitted and the product lacks mandatory English labeling statements.

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 product with both missing pre-market notifications and non-compliant labeling. Infant formula is a high-risk product category where regulatory compliance and proper labeling are critical for safe use, particularly given the vulnerable population served.

Plain-English summary

Able Groupe Inc is recalling Kendamil Organic Stage 1 First Infant Milk Formula, totaling 76,000 units. The recall was initiated because the required pre-market notifications for this new 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.

The product was sold directly from the firm's website at littlebundle.com. Consumers who have purchased this product should not use it and should contact the recalling firm for further instructions.

The recalled product

Product
Kendamil Organic Stage 1 First Infant Milk Formula
Manufacturer
Able Groupe Inc
Category
Food — Infant Formula
Hazard
  • missing-premarket-notification
  • mis-labeling
  • non-compliant-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.

Related recalls

Same category