Lebenswert Folgemilch Stage 3 Organic Toddler Formula
Able Groupe Inc recalled this product and the FDA reported the enforcement action on 25 August 2021 as Class II. The recall was initiated by the firm. 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.
The record
Every field below is published by the FDA in the openFDA food enforcement database. Check the FDA notice before acting on any recall: this page is a reading of the public record, not a substitute for it.
- Product
- Lebenswert Folgemilch Stage 3 Organic Toddler 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.
- Recalling firm
- Able Groupe Inc
- Firm location
- Sparks, Nevada, United States
- Classification
- Class II
- Status
- Terminated
- Recall number
- F-0923-2021
- Quantity
- 76,000 units total
- Distribution
- All sales are direct from firm website - littlebundle.com
- Initiated
- 8 August 2021
- Reported by FDA
- 25 August 2021
- Terminated
- 8 September 2021
- Firm notified by
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Product codes
- All codes
Reading this record
Five things about this record are not in the record itself, and each one changes how it should be read.
- Class II means the FDA judged a remote probability of serious harm, or a probability of temporary or medically reversible harm. The class is assigned by an agency health hazard evaluation under 21 CFR 7.41, not by the firm.
- The firm started this recall itself. Most FDA food recalls are voluntary, and a recall is a food safety plan working rather than failing. The circumstances in which the agency asks for one instead are set out in 21 CFR 7.45.
- This is one of 21 records covering the same recall event. The FDA opens one enforcement record per product code, so a recall of a product line appears here many times. Counting these records as 21 separate recalls, which almost every published figure does, overstates it by a factor of 21. Every product code in this event is listed together on the record that covers the whole recall, which is the page a search engine is pointed to for all 21 of them.
- The recall ran for 4 weeks, from 8 August 2021 to termination on 8 September 2021. Termination means the agency judged that all reasonable effort had been made, under 21 CFR 7.55, and it says nothing about whether product remained in circulation.
- The FDA published the enforcement report 2 weeks after the firm began the recall.
- Recalls of infant formula or baby food run a median of 10 months, so this one was shorter than usual for its category. Infant formula is the most tightly regulated food in the United States because it is frequently the only thing an infant eats, so a nutrient deviation is a hazard in a way it is not in any other product.
Filed under infant formula and baby food. A product can sit in more than one.
Other infant formula and baby food recalls
These are the closest records in the corpus: the same kind of food. Unlike the firm’s own records below, they come from different companies, which is what makes them a pattern rather than a history.
Other records from Able Groupe Inc
The FDA opens one enforcement record per product code, so several of these are frequently one recall event. 20 other records name this firm.
| Reported | Product | Firm | Reason | Class |
|---|---|---|---|---|
| 2021-08-25 | Lebenswert Anfangsmilch Stage 1 Organic Infant Milk Formula | Able Groupe Inc | 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. | Class I |
| 2021-08-25 | HiPP HA Germany Hypoallergenic Stage 1 Combiotic Infant Milk Formula | Able Groupe Inc | 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. | Class II |
| 2021-08-25 | Holle Goat Stage 1 Organic Infant Milk Formula | Able Groupe Inc | 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. | Class II |
| 2021-08-25 | HiPP Comfort Milk Formula | Able Groupe Inc | 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. | Class I |
| 2021-08-25 | HiPP HA Germany Hypoallergenic Stage PRE Combiotic Infant Milk Formula | Able Groupe Inc | 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. | Class I |
| 2021-08-25 | HiPP Dutch Stage 2 Combiotic Follow-on Milk Formula | Able Groupe Inc | 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. | Class II |
| 2021-08-25 | Holle Bio Stage 2 Organic Follow-On Infant Milk Formula | Able Groupe Inc | 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. | Class II |
| 2021-08-25 | Kendamil Organic Stage 2 Follow on Milk Formula | Able Groupe Inc | 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. | Class II |
| 2021-08-25 | Holle Goat Stage 2 Organic Follow-On Infant Milk Formula | Able Groupe Inc | 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. | Class II |
| 2021-08-25 | HiPP HA Germany Hypoallergenic Stage 2 Combiotic Follow-On Infant Milk Formula | Able Groupe Inc | 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. | Class II |
All 21 records for Able Groupe Inc
All 2021 recalls · All FDA food recall data
Behind every recall is a clause somebody has to produce evidence for at their next audit. Krolda maps supplier documents to the clause they satisfy in FSSC 22000, IFS Food and 21 CFR 117, and routes the corrective action when the evidence is missing.
Early accessRecall records come from the openFDA food enforcement API, published by the U.S. Food and Drug Administration in the public domain. Krolda adds the hazard classification and the clause mapping; neither is an FDA determination. Always check the FDA notice before acting on a recall.