Holle Goat Stage 1 Organic Infant Milk Formula Recalled for Labeling Violations
Able Groupe Inc is recalling Holle Goat Stage 1 Organic Infant Milk Formula because required FDA pre-market notifications were not submitted and products lack mandatory labeling statements in English.
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 3/5 (High).
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 recall of an infant formula product with regulatory violations (missing pre-market notifications and required labeling). Although no illnesses or injuries are reported in the source text, infant formula is a high-risk product where labeling deficiencies and lack of FDA oversight create potential harm, meeting the High severity threshold.
Plain-English summary
Able Groupe Inc is recalling all codes of Holle Goat Stage 1 Organic Infant Milk Formula, totaling 76,000 units. The products were distributed directly through the firm's website at littlebundle.com.
The recall was issued because the required pre-market notifications for these infant formulas were not submitted to the FDA. Additionally, the products are not labeled as required by 21 CFR 107.10 and 107.20 and do not bear mandatory labeling statements in English.
Consumers who have purchased this product should stop using it and contact the firm for instructions on returns or refunds.
The recalled product
- Product
- Holle Goat Stage 1 Organic 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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