Recalls / Class I
Class IF-0914-2021
Class I— FDA's most serious classification, issued when there is a reasonable probability that consumption of or exposure to the product will cause serious adverse health consequences or death.
Product
HiPP German Stage 1 Combiotic Infant Milk Formula
- Type
- Food
- Affected lot / code info
- All codes
- Quantity
- 76,000 units total
Why it was 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.
Recalling firm
- Firm
- Able Groupe Inc
- Notification channel
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Type
- Voluntary: Firm initiated
- Address
- 1486 Kleppe Ln, N/A, Sparks, Nevada 89431-6428
Distribution
- Distribution pattern
- All sales are direct from firm website - littlebundle.com
Timeline
- Recall initiated
- 2021-08-08
- FDA classified
- 2021-09-01
- Posted by FDA
- 2021-08-25
- Terminated
- 2021-09-08
- Status
- Terminated
Source: openFDA Food Enforcement endpoint. Recall record F-0914-2021. The FDA issues recall classifications as health-hazard assessments, not legal findings.