Food recall: HiPP Comfort Milk Formula
Class I FDA enforcement event 88432. Recall start date: . Status in the FDA record: Terminated. Termination date: .
Reason for recall, in the words of FDA
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 I, in the words of FDA
a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death
Able Groupe Inc started this food recall on 8 Aug 2021. The firm address in the FDA record is in Sparks, NV. FDA put the recall in Class I. FDA event 88432 has 21 product records. The first FDA enforcement report date is 25 Aug 2021. The record gives the status Terminated, with the termination date 8 Sep 2021.
It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on . openFDA export of .
Distribution
In the words of FDA.
All sales are direct from firm website - littlebundle.com
Recalling firm
Able Groupe Inc, Sparks, NV.
Recalling firm: The firm that the FDA record names for a recall.
FDA records how the recall started: Voluntary: Firm initiated.
Products
21 product records in the event.
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| F-0907-2021 | HiPP Comfort Milk Formula | 76,000 units total | Class I | Terminated | 25 Aug 2021 |
| F-0908-2021 | HiPP AR Germany Anti-Reflux Milk Formula | 76,000 units total | Class II | Terminated | 25 Aug 2021 |
| F-0909-2021 | HiPP Dutch Stage 1 Combiotic Infant Milk Formula | 76,000 units total | Class I | Terminated | 25 Aug 2021 |
| F-0910-2021 | HiPP HA Germany Hypoallergenic Stage PRE Combiotic Infant Milk Formula | 76,000 units total | Class I | Terminated | 25 Aug 2021 |
| F-0911-2021 | HiPP Dutch Stage 2 Combiotic Follow-on Milk Formula | 76,000 units total | Class II | Terminated | 25 Aug 2021 |
| F-0912-2021 | HiPP HA Germany Hypoallergenic Stage 1 Combiotic Infant Milk Formula | 76,000 units total | Class II | Terminated | 25 Aug 2021 |
| F-0913-2021 | HiPP HA Germany Hypoallergenic Stage 2 Combiotic Follow-On Infant Milk Formula | 76,000 units total | Class II | Terminated | 25 Aug 2021 |
| F-0914-2021 | HiPP German Stage 1 Combiotic Infant Milk Formula | 76,000 units total | Class I | Terminated | 25 Aug 2021 |
| F-0915-2021 | HiPP German Stage 2 Combiotic Follow-on Infant Milk Formula | 76,000 units total | Class II | Terminated | 25 Aug 2021 |
| F-0916-2021 | Holle Bio Stage 1 Organic Infant Milk Formula | 76,000 units total | Class I | Terminated | 25 Aug 2021 |
| F-0917-2021 | Holle Bio Stage PRE Organic Infant Milk Formula | 76,000 units total | Class I | Terminated | 25 Aug 2021 |
| F-0918-2021 | Holle Bio Stage 2 Organic Follow-On Infant Milk Formula | 76,000 units total | Class II | Terminated | 25 Aug 2021 |
| F-0919-2021 | Holle Goat Stage 1 Organic Infant Milk Formula | 76,000 units total | Class II | Terminated | 25 Aug 2021 |
| F-0920-2021 | Holle Goat Stage 2 Organic Follow-On Infant Milk Formula | 76,000 units total | Class II | Terminated | 25 Aug 2021 |
| F-0921-2021 | Lebenswert Anfangsmilch Stage 1 Organic Infant Milk Formula | 76,000 units total | Class I | Terminated | 25 Aug 2021 |
| F-0922-2021 | Lebenswert Folgemilch Stage 2 Organic Follow-On Infant Milk Formula | 76,000 units total | Class II | Terminated | 25 Aug 2021 |
| F-0923-2021 | Lebenswert Folgemilch Stage 3 Organic Toddler Formula | 76,000 units total | Class II | Terminated | 25 Aug 2021 |
| F-0924-2021 | HiPP UK Stage 1 Combiotic First Infant Milk Formula | 76,000 units total | Class I | Terminated | 25 Aug 2021 |
| F-0925-2021 | HiPP UK Stage 2 Combiotic Follow-On Infant Milk Formula | 76,000 units total | Class II | Terminated | 25 Aug 2021 |
| F-0926-2021 | Kendamil Organic Stage 1 First Infant Milk Formula | 76,000 units total | Class II | Terminated | 25 Aug 2021 |
| F-0927-2021 | Kendamil Organic Stage 2 Follow on Milk Formula | 76,000 units total | Class II | Terminated | 25 Aug 2021 |
openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports.
Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.
Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.
Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.
Class I: The highest of the three FDA recall classes.
The event in context
- Food events that started in 2021
- 463
- Share of these events in Class I
- 35%
- Product records in this event
- 21
- Events of the firm on the register
- 1
Official channels
- FDA enforcement report F-0907-2021The FDA record of the first product of this event.
- FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
- FDA: report a problemThe FDA page that shows where a report about a product goes.
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Cite this page
Recall Register. FDA enforcement event 88432. https://recallregister.com/fda/i/88432/. Source: openFDA enforcement reports. Data through .
Sources
- Source
- openFDA food enforcement reports
- Licence
- CC0 1.0
- Export date
- 28 Sep 2026
- Newest FDA report date on the register
- 23 Sep 2026
FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.
Questions
- Where was the product distributed?
- The FDA record gives this distribution:
All sales are direct from firm website - littlebundle.com
- What quantity of product is in FDA event 88432?
- The event has 21 product records. The first record gives this quantity:
76,000 units total
- How did the recall start?
- The FDA record says:
Voluntary: Firm initiated
- How many food recalls of 2021 have the same class?
- 35% of the 463 food events that started in 2021 are in Class I.