Recalled formula is still on shelves. The FDA is warning retailers.

The FDA has sent warning letters to multiple major retailers after finding 175 locations in 36 states still selling voluntarily recalled ByHeart infant formula—recalled on Nov. 8—linked to an outbreak of infant botulism that has increased to 51 suspected or confirmed cases across 19 states as of Dec. 16, with all patients hospitalized but no deaths reported. The recall covers all batches of ByHeart Whole Nutrition Infant Formula cans and single‑serve “anywhere pack” sticks, and the FDA urged retailers to follow their legal obligations under the Federal Food, Drug, and Cosmetic Act and adopt stronger recall practices. Retailers and ByHeart face regulatory and reputational risk as the company offers limited refunds and the CDC urges caregivers to stop using the product, monitor infants for symptoms, and preserve leftover formula for potential testing.

Analysis

The FDA issued warning letters on Dec. 12 after finding 175 retail locations across 36 states still selling voluntarily recalled ByHeart Whole Nutrition Infant Formula cans and single-serve Anywhere Packs; the recall was initiated Nov. 8 after a cluster of infant botulism cases that the CDC reports rose from 13 in 10 states to 51 suspected or confirmed cases across 19 states as of Dec. 16, with all cases hospitalized but no deaths reported. ByHeart has offered limited refunds (full refunds for up to two products and for first-time customers on first orders) and the CDC is advising caregivers to stop use, monitor infants for symptoms (poor feeding, loss of head control, difficulty swallowing) and preserve leftover formula for potential testing. The FDA framed the letters as a reminder of legal obligations under the Federal Food, Drug, and Cosmetic Act and called for stronger recall execution, signaling elevated regulatory and reputational risk for both ByHeart and retailers that failed to remove stock. For investors this raises near-term operational and liability exposure for parties in the distribution chain, potential inventory write-downs and refund costs for ByHeart and retailers, and a plausible short-term shift in consumer demand toward alternative formula suppliers that complied promptly.

Key Decisions for Investors

• Monitor which retailers were named and whether they remediate inventory quickly; consider trimming exposure to retailers confirmed noncompliant until regulatory actions and removal are complete
• Track CDC case counts and any laboratory confirmations linking products to cases because escalation would increase likelihood of fines, litigation and broader category weakness—consider hedging consumer staples or retail exposure to the infant-formula category
• Favor or rotate into retailers and branded suppliers that demonstrate rapid, transparent recall execution and clear remediation plans as potential relative winners while avoiding firms with unresolved compliance or reputational issues