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.
The agency’s classification
FDA (Food): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. 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
Same manufacturer · Able Groupe Inc
See all →- SevereHiPP UK Stage 1 Infant Milk Formula Lacks Required FDA Approval
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- HighKendamil Organic Stage 2 Infant Formula Recalled for Missing Labeling
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- HighHolle Goat Stage 1 Organic Infant Milk Formula Recalled for Labeling Violations
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- SevereHiPP Comfort Milk Formula Recalled for Inadequate Iron and Labeling Violations
FDA (Food) · 2021-08-25
- SevereLebenswert Anfangsmilch Stage 1 Infant Formula Recall for Inadequate Iron and Labeling
FDA (Food) · 2021-08-25
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