FDA Food recall · Reported August 25, 2021
Holle Goat Stage 1 Organic Infant Milk Formula
The required pre-market notifications for these new infant formulas have not been submitted to the FDA. All products are not labeled as required by 21 CFR 107 .10 and 107.20 and…
Able Groupe Inc recalled Holle Goat Stage 1 Organic Infant Milk Formula - a moderate-severity action.
Holle Goat Stage 1 Organic Infant Milk Formula was recalled by Able Groupe Inc in August 25, 2021. Reason: The required pre-market notifications for these new infant formulas have not been submitted to the FDA. All…. Check the official notice for the remedy. Verify recall #F-0919-2021 with the FDA Food before acting.
The recall
Able Groupe Inc issued this moderate-severity FDA Food recall-The required pre-market notifications for these new infant formulas have not been submitted to the FDA. All….
- Moderate
- severity level
- 76K units
- affected scope
- Class II
- classification
- August 25, 2021
- reported
Sourced from official FDA Food enforcement records. Verify recall #F-0919-2021 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This recall's affected scope, documented in the Recall Profile below, stays within a single-region or limited-distribution footprint. Distribution scope (see Distribution below) directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Children & Baby Products recalls over time
Where this recall sits in its category - 3,781 children & baby products recalls on record
Of 88,244 recalls with an agency hazard classification, 19,068 are high severity, 64,652 moderate, and 4,524 low. A further 16,179 CPSC/NHTSA recalls have no agency class and are excluded from this split. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Product description
Holle Goat Stage 1 Organic Infant Milk Formula
Reason for recall
The required pre-market notifications for these new infant formulas have not been submitted to the FDA. All products are not labeled as required by 21 CFR 107 .10 and 107.20 and do not bear mandatory labeling statements in English.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | F-0919-2021 |
| Date reported | August 25, 2021 |
| Date initiated | August 8, 2021 |
| Recalling firm | Able Groupe Inc |
| Firm location | Sparks, NV |
| Affected scope | 76,000 units total |
| Distribution | All sales are direct from firm website - littlebundle.com |
Profile values are sourced directly from the official FDA Food enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (F-0919-2021) and product description against the item you own. Search the archive
- Confirm the current status with FDA Food before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Food record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
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Nationwide recalls with similar severity or category timing
Food and dietary-supplement notices outside this firm and state, matched by severity timing and product category.
Similar severity · nearest report date
Same archive severity grade (Moderate), closest by report date among other firms and states.
Similar Children & Baby Products · nearest report date
Same product category, closest by report date among other firms and states (deduped against the severity set).
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Methodology · Corrections · Archive as of August 2026