Severity
Critical
CriticalClass ITerminated
FDA Food recall · Reported August 25, 2021
HiPP Dutch Stage 1 Combiotic Infant Milk Formula
The required pre-market notifications for these new infant formulas have not been submitted to the FDA. Some products contain less than 1 milligram of iron per 100 Calories and m…
Able Groupe Inc recalled HiPP Dutch Stage 1 Combiotic Infant Milk Formula — a critical-severity action.
HiPP Dutch Stage 1 Combiotic 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. Some…. Check the official notice for the remedy. Verify recall #F-0909-2021 with the FDA Food before acting.
The recall
Able Groupe Inc issued this critical-severity FDA Food recall — The required pre-market notifications for these new infant formulas have not been submitted to the FDA. Some….
- Critical
- severity level
- 76K units
- affected scope
- Class I
- classification
- August 25, 2021
- reported
Sourced from official FDA Food enforcement records. Verify recall #F-0909-2021 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Food action (record #F-0909-2021) was formally reported on August 25, 2021, with the manufacturer initiating the action on August 8, 2021. It is classified under Critical severity (Class I), with a current status of Terminated. Able Groupe Inc is listed as the recalling firm, operating out of Sparks, NV. Federal records list the affected scope as 76,000 units total.
The documented reason for this recall is: The required pre-market notifications for these new infant formulas have not been submitted to the FDA. Some products contain less than 1 milligram of iron per 100 Calories and may not provide adequate iron for some in… Distribution data in the federal record shows the product reached: All sales are direct from firm website - littlebundle.com. Distribution scope 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, 6 from FDA Food — 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 — 3,146 children & baby products recalls on record
Where this recall sits in the database
Of 100,165 recalls in the database, 23,668 are high severity, 72,097 moderate, and 4,400 low. This recall is classified high severity.
Counts reflect market size and reporting activity, not inherent danger — we do not rank products by risk from raw recall volume.
Affected scope
76,000 units total
Related Recalls
6
6 from same agency
Product description
HiPP Dutch Stage 1 Combiotic Infant Milk Formula
Reason for recall
The required pre-market notifications for these new infant formulas have not been submitted to the FDA. Some products contain less than 1 milligram of iron per 100 Calories and may not provide adequate iron for some infants, particularly infants born prematurely or with a low birth weight, had low iron levels at birth, or are at risk for becoming iron deficient due to illness. 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 | Critical (Class I) |
| Status | Terminated |
| Recall number | F-0909-2021 |
| 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-0909-2021) 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.
- This is a Class I (high-risk) recall — stop using the product immediately and follow the disposal or return instructions. 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.
Frequently Asked Questions
What product was recalled? ▼
HiPP Dutch Stage 1 Combiotic Infant Milk Formula. Recalled by Able Groupe Inc. Units affected: 76,000 units total.
Why was this product recalled? ▼
The required pre-market notifications for these new infant formulas have not been submitted to the FDA. Some products contain less than 1 milligram of iron per 100 Calories and may not provide adequate iron for some infants, particularly infants born prematurely or with a low birth weight, had low iron levels at birth, or are at risk for becoming iron deficient due to illness. All products are not labeled as required by 21 CFR 107 .10 and 107.20 and do not bear mandatory labeling statements in English.
Which agency issued this recall? ▼
This recall was issued by the FDA Food on August 25, 2021. Severity: Critical. Recall number: F-0909-2021.
Where was the recalled product distributed? ▼
Distribution: All sales are direct from firm website - littlebundle.com.
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (F-0909-2021) against your product. Visit the official FDA Food website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
What are the health risks of consuming a recalled food product? ▼
Recalled food products may contain contaminants, undeclared allergens, or harmful bacteria such as Salmonella, Listeria, or E. coli. Consuming these products can cause foodborne illness ranging from mild gastrointestinal symptoms to serious conditions requiring hospitalization. If you have consumed a recalled food product and experience symptoms, contact your healthcare provider and report to the FDA via MedWatch.
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What to do next
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Other recalls in the same product category — useful for spotting patterns across the same defect class or manufacturer.
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Data Sources
Source: FDA, CPSC, and NHTSA federal recall databases. This recall: FDA Food, reported August 25, 2021.
- Source: FDA — Food and Drug Administration, openFDA Enforcement API (food, drug, and medical device recalls)
- Source: CPSC — Consumer Product Safety Commission Recalls API (consumer product recalls and hazards)
- Source: NHTSA — National Highway Traffic Safety Administration Recalls API (vehicle safety recalls)
Recall information is sourced from official federal agency databases. Always verify recall details with the issuing agency for the most current status. This information is for research and awareness purposes only.
Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records — no number is typed in by an editor. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of June 2026.