FDA Food Recalls

Recalls / Class I

Class IF-0291-2023

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

By Heart Whole Nutrition Infant Formula, Net Wt. 24 oz. 680 g

Type
Food
Affected 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
28,554 cans

Why it was recalled

Infant formula potentially contaminated with Cronobacter sakazakii

Recalling firm

Firm
ByHeart, INC.
Notification channel
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Type
Voluntary: Firm initiated
Address
131 Varick St, N/A, New York, New York 10013-1410

Distribution

Distribution pattern
nationwide direct to consumer subscription e-commerce sales

Timeline

Recall initiated
2022-12-11
FDA classified
2023-01-19
Posted by FDA
2023-01-25
Terminated
2024-04-16
Status
Terminated

Source: openFDA Food Enforcement endpoint. Recall record F-0291-2023. The FDA issues recall classifications as health-hazard assessments, not legal findings.

Class I food recall: By Heart Whole Nutrition Infant Formula, Net Wt. 24 oz. 680 g · FDA Food Recalls