Summary
The FDA issued a Class I for By Heart Whole Nutrition Infant Formula, Net Wt. 24 oz. 680 g by ByHeart, INC.. Reason: Infant formula potentially contaminated with Cronobacter sakazakii.
Details
Source
Food Recall
External ID
F-0291-2023
Action Date
2023-01-25
Status
Terminated
Category
food
Product Description
By Heart Whole Nutrition Infant Formula, Net Wt. 24 oz. 680 g
Lot/Code Info: Packaged between September 30, 2022 and October 07, 2022 printed with following codes: 22273 C1, 22276 C1, 22277 C1, 22278 C1, and 22280 C1 with best by 01 JAN 24 or 01 JUL 24 or 01SEP24 UPC Codes: 19589362296
Quantity Affected: 28,554 cans
Reason for Recall
Infant formula potentially contaminated with Cronobacter sakazakii
Distribution
nationwide direct to consumer subscription e-commerce sales
Type: Voluntary: Firm initiated
Recall Initiated: 2022-12-11
Company
New York, NY
Context & Analysis
This is a Class I recall. Class I recalls are the most serious — there is a reasonable probability that use of or exposure to the product will cause serious health consequences or death.
This was one of 84 food recalls issued in the same week, part of 204 food-related FDA actions this month.
ByHeart, INC. has 2 FDA actions in our database, including 2 recalls.
Frequently Asked Questions
What is a Class I recall?
A Class I recall is the most serious type. The FDA has determined there is a reasonable probability that the product will cause serious adverse health consequences or death. Consumers should stop using the product immediately.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (ByHeart, INC.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does ByHeart, INC. have FDA actions?
ByHeart, INC. has 2 FDA actions in our database, including 2 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "F-0291-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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