PlainRecalls
FDA Food Verify with FDA Food → Critical Class I Terminated

Lebenswert Anfangsmilch Stage 1 Organic Infant Milk Formula

Reported: August 25, 2021 Initiated: August 8, 2021 #F-0921-2021 76,000 units total units

Able Groupe Inc issued this FDA Food recall on August 25, 2021. Classified as Critical severity (Class I). Approximately 76,000 units total units are affected. The recall was issued because: The required pre-market notifications for these new infant formulas have not been submitted to the FDA. Some products …. This recall notice is sourced from official FDA Food enforcement records. Below you will find the complete product description, hazard information, remedy instructions, and related recalls from the same manufacturer or product category.

Recall Insight

This FDA Food action (record #F-0921-2021) 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 indicate 76,000 units total units are affected.

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.

To put this record in context, PlainRecalls indexes 83,949 recalls across the FDA, CPSC, NHTSA and USDA FSIS going back to 1995. Within the same product category, the database holds 6 closely related recalls. That clustering is a signal — repeated actions in a narrow category often indicate a systemic quality-control issue, a supplier-wide contamination, or a design defect that has propagated across product lines. This recall is roughly 5 years old; older recalls can remain relevant because many units enter resale, rental, and secondary-market channels where the original warning never reaches the end user. Always cross-check the recall number against the official agency page before relying on any summary.

Recall Distribution by Severity Class

Severity1Class I (Critical)Class II (Moderate)Class III (Low)
Recall Distribution by Severity Class

Severity

Critical

Units Affected

76,000 units total

Related Recalls

6

0 from same agency

Product Description

Lebenswert Anfangsmilch 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. 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.

Details

Recalling Firm
Able Groupe Inc
Units Affected
76,000 units total
Distribution
All sales are direct from firm website - littlebundle.com
Location
Sparks, NV

Recall Profile

Structured summary of the FDA Food recall record
Attribute Value
Agency U.S. Food and Drug Administration
Severity class Critical (Class I)
Status Terminated
Recall number F-0921-2021
Date reported August 25, 2021
Date initiated August 8, 2021
Recalling firm Able Groupe Inc
Units affected 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.

Scale of Impact

76,000 units total units affected — limited or regional distribution scale.

Regional (<10K units)
Multi-state (10K – 100K units) ✓ This recall
Large-scale (100K – 1M units)
Massive (≥1M units)

Bracket cutoffs follow federal recall-disclosure conventions; bar widths scale linearly within each bracket. Source: PlainRecalls analysis of U.S. Food and Drug Administration filings.

Frequently Asked Questions

What product was recalled?
Lebenswert Anfangsmilch Stage 1 Organic 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-0921-2021.
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-0921-2021) 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.

Recall Context

Product recalls are issued when a manufacturer, distributor, or federal agency determines that a product poses a safety risk to consumers. This recall is classified as critical severity, meaning the product carries a reasonable probability of serious adverse health consequences or death. Across PlainRecalls, we track 83,000+ recalls from FDA, CPSC, and NHTSA to help consumers stay informed and act quickly when safety issues arise.

Nearby Recalls in This Category

Other recalls in the same product category — useful for spotting patterns across the same defect class or manufacturer.

Compare this recall with Infant Walkers Recalled Due to Risk of Serious Injury or De… →

Data Sources

Data as of 2025. Source: FDA, CPSC, NHTSA, USDA FSIS federal recall databases.

  • 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)
  • Source: USDA FSIS — Food Safety and Inspection Service (meat, poultry, and egg product 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.

All federal data sources used on this page

Source: Federal recall agencies (FDA, CPSC, NHTSA, USDA FSIS) Aggregated multi-agency recall feeds · 2024 Recall data normalized across federal agency feeds; severity classifications follow each agency's own taxonomy (FDA Class I/II/III; CPSC, NHTSA, USDA FSIS).