July 14, 2026

FDA finds botulinum toxin gene in powdered milk, tells formula makers to overhaul supply chains

The agency's July 13 letter reveals 2 of 48 powdered milk samples tested positive, a shared milk supplier left Nara Organics off a critical FDA list, and a separate global cereulide outbreak triggered an a2 Milk formula recall in the US. Plus Hyundai and Kia recall exactly 14 EVs over battery fire risk with a park-outside warning, and Medtronic's Harmony heart valve delivery catheter earns its second Class I recall for the same tip-detachment defect.

If you feed a baby powdered infant formula, the FDA's newest letter to the industry is worth reading closely. On July 13, the agency wrote to infant formula manufacturers, packagers, distributors, importers, and retailers urging them to exercise what it calls "substantive oversight" of their suppliers, after two botulism outbreaks and a separate global toxin contamination event all traced back to contaminated ingredients (Food Safety Magazine).

The letter is not a new recall. It is the regulatory reckoning after one, and it contains findings that have not been public before.

FDA reveals botulinum toxin gene in powdered milk, DFA facility match

What is new: The FDA's letter discloses the results of a surveillance sampling assignment it ran in February 2026, after the first botulism outbreak. The agency collected 48 powdered milk samples from four suppliers to infant formula manufacturers. Forty-six were negative. Two samples, both organic nonfat milk powder from the same firm, tested positive by PCR for Clostridium botulinum. Whole genome sequencing later identified the organism as C. sporogenes carrying a gene highly associated with botulinum toxin B1. The FDA says this finding suggests, but does not confirm, that the bacterium could produce botulinum toxin under certain conditions.

Separately, testing during the ByHeart outbreak investigation revealed C. botulinum in a powdered milk ingredient, and matched C. botulinum isolates recovered from a Dairy Farmers of America (DFA) processing facility to isolates from a clinical case and a finished formula product sample. For a period in 2025, both ByHeart and Nara Organics used organic whole milk supplied by Organic West Milk and dried at a DFA facility. The ByHeart outbreak ended in February 2026 with 48 babies sickened in 17 states. The Nara Organics outbreak, which we have been tracking since July 11, remains ongoing with four hospitalized infants in California, Pennsylvania, and Washington.

The supplier failure: Before the Nara outbreak emerged, the FDA conducted a trace-forward investigation to determine whether Organic West Milk had supplied milk to any formula maker other than ByHeart. Organic West Milk gave the FDA an incomplete customer list and failed to disclose that its milk was also going to Nara Organics. The FDA's letter does not say whether earlier disclosure would have prevented the Nara cases, but the timeline implies the agency could have flagged Nara before any baby got sick.

The cereulide angle: A separate multinational contamination event from late 2025 through early 2026 caused nearly 150 suspected and confirmed cases of cereulide intoxication in babies across ten countries. Cereulide is a heat-stable toxin produced by Bacillus cereus. It entered the global formula supply through contaminated arachidonic acid (ARA) oil from a Chinese supplier, CABIO Biotech in Wuhan, used as an ingredient by multiple brands including Nestle, Danone, and Lactalis. The contamination triggered downstream recalls in 99 countries. In the US, a2 Milk Company voluntarily recalled specific batches of its imported a2 Platinum Premium powdered infant formula on May 2, 2026, after cereulide was detected. On May 12, the FDA added all ARA oil and powdered ARA oil products from CABIO Biotech to Import Alert 99-51, allowing customs to detain those shipments without physical inspection (Reuters via KRRO).

What to do: If you have Nara Organics Whole Milk Organic Powdered Infant Formula, stop using it. The recall covers all lots, sold at Target, Target.com, and Nara.com from July 2025 through June 2026. The CDC's outbreak page is here. If you purchased a2 Platinum Premium formula, check the FDA's recall announcements for affected batch numbers. The FDA's letter does not announce a ban on infant formula, and the agency says products currently on the market are not broadly contaminated. The risk pattern it identified is specific to ingredients from particular suppliers, not the entire formula supply.

Hyundai and Kia recall exactly 14 EVs over battery fire risk, park outside

What: Hyundai and Kia have filed twin recalls covering a total of 14 electric vehicles in the United States because high-voltage battery cells from supplier SK On may have misaligned electrodes that can cause an internal short circuit and fire. NHTSA campaign 26V431 covers Kia (recall SC375) and 26V432 covers Hyundai (recall 305).

Which vehicles: Six Hyundai IONIQ 5 from model years 2023 and 2024, seven Kia EV6 from model years 2022 through 2024, and one 2024 Kia EV9. The affected vehicles were built between December 30, 2021, and October 28, 2023. Kia estimates a 100 percent defect rate within this specific eight-vehicle population, meaning every recalled vehicle is expected to have the condition.

Why: Misaligned electrodes inside specific battery cells can trigger an internal short circuit, leading to thermal runaway. The fire can start while the vehicle is parked or being driven, with no warning sign a driver would notice. Hyundai and Kia identified the affected units by tracing SK On battery modules through production records after fires were reported in the South Korean market. No fires, crashes, or injuries have been reported in the United States (Electrek).

What to do: Park outside and away from structures until the repair is complete. Limit battery charging to 80 percent. The fix is a complete replacement of the high-voltage battery system assembly, free of charge. Kia will mail owner notification letters on August 7 (call 1-800-333-4542). Hyundai will mail letters on August 31 (call 855-371-9460). VINs become searchable on NHTSA.gov/recalls starting July 17.

A 14-vehicle recall is unusually small, but the hazard is the same category that drives million-unit campaigns: a battery fire that can start with the car off and parked. If you own one of these models, do not assume yours is unaffected because the numbers are low. Check your VIN on July 17.

Medtronic recalls Harmony heart valve delivery catheter again, Class I

What: The FDA has classified Medtronic's recall of certain lots of the Harmony Delivery Catheter System (DCS) as Class I, the most serious type. The distal tip of the catheter can detach during the implant procedure, requiring a secondary intervention to retrieve it, either endovascularly or surgically. Additional risks include prolonged procedure time, extended fluoroscopy time, occlusion, tissue damage, pulmonary regurgitation, embolism, and hemorrhage. Medtronic issued a letter to affected hospitals and physicians on May 28, and the FDA posted the classification on July 13 (MassDevice).

Scale: More than 1,800 catheter sets are affected across multiple lot numbers. Medtronic has received two complaints of distal tip detachment during implant procedures as of May 14, 2026. In both cases, the detached tip was retrieved endovascularly, and no serious injuries or deaths have been reported.

The repeat: This is the second Class I recall for the same device for the same type of defect. In April 2022, the FDA recalled 665 Harmony delivery catheters because the capsule bond could break during use, causing six complaints and one injury. Medtronic improved the bonding process, received FDA approval to relaunch in February 2023, and the redesigned version is now failing the same way. The FDA's medical device recalls page is here.

What to do: This is a hospital and physician action, not a consumer one. If you or your child has a successfully implanted Harmony transcatheter pulmonary valve (TPV), the valve itself is not affected and no additional action is needed. The recall covers only the delivery catheter used during the implantation procedure. Healthcare providers should immediately quarantine and return all affected lots to Medtronic.

Tracking: Clover Hill cheese listeria outbreak

The CDC's investigation remains open with 12 illnesses, 10 hospitalizations, and 1 death (Maryland) unchanged since late June. The La Ceiba Foods requeson sold under the La Colonia and Selectos Latinos brands had a July 10 expiration date, which has now passed. If any of this cheese is still in your refrigerator, throw it out. Clover Hill cheese may have been repackaged under the brands Kesso, Quesos la Ricura, Izalco, De mi Pueblo, or Rio Lindo. Maryland has suspended Clover Hill Dairy's operating license. The CDC outbreak page is here.