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
- Affected units
- 76,000
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.
Part of a larger recall action
This product is one of 21 recalled by Able Groupe Inc under a single FDA (Food) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 21 products in this recall →Related recalls
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