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

Recall Insight

This FDA Food action (record #F-0291-2023) was formally reported on January 25, 2023, with the manufacturer initiating the action on December 11, 2022. It is classified under Critical severity (Class I), with a current status of Terminated. ByHeart, INC. is listed as the recalling firm, operating out of New York, NY. Federal records indicate 28,554 cans units are affected.

The documented reason for this recall is: Infant formula potentially contaminated with Cronobacter sakazakii Distribution data in the federal record shows the product reached: nationwide direct to consumer subscription e-commerce sales. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.

To put this record in context, PlainRecalls indexes 83,949 recalls across the FDA, CPSC, NHTSA and USDA FSIS going back to 1995. Within the same product category, the database holds 6 closely related recalls, of which 6 were also issued by FDA Food. That clustering is a signal — repeated actions in a narrow category often indicate a systemic quality-control issue, a supplier-wide contamination, or a design defect that has propagated across product lines. This recall is roughly 3 years old; older recalls can remain relevant because many units enter resale, rental, and secondary-market channels where the original warning never reaches the end user. Always cross-check the recall number against the official agency page before relying on any summary.