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.
Product description
HiPP HA Germany Hypoallergenic Stage PRE Combiotic Infant Milk Formula
Lot numbers, UPCs & expiration codes
All codes
Where it was sold
All sales are direct from firm website - littlebundle.com
What to do if you have this product
- Compare the brand, size, and lot/UPC codes on your package with the codes above.
- If it matches, don't eat it. Return it to the store for a refund or throw it away.
- Wash surfaces and containers that touched the product.
- If you feel sick after eating it, contact your doctor. In an emergency call 911.
Recall details
- Recall number
- F-0910-2021
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- Aug 8, 2021
- FDA report date
- Aug 25, 2021
- Quantity
- 76,000 units total
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Able Groupe Inc
Original FDA data
Every field from FDA enforcement report F-0910-2021, exactly as published.
Show all FDA fields
- City
- Sparks
- State
- NV
- Status
- Terminated
- Country
- United States
- Event ID
- 88432
- Address
- 1486 Kleppe Ln
- Code information
- All codes
- Postal code
- 89431-6428
- Report date
- Aug 25, 2021
- Product type
- Food
- Recall number
- F-0910-2021
- Classification
- Class I
- Recalling firm
- Able Groupe Inc
- Product quantity
- 76,000 units total
- Termination date
- Sep 8, 2021
- 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.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- HiPP HA Germany Hypoallergenic Stage PRE Combiotic Infant Milk Formula
- Distribution pattern
- All sales are direct from firm website - littlebundle.com
- Recall initiation date
- Aug 8, 2021
- Initial firm notification
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Center classification date
- Sep 1, 2021