ByHeart Formula Recall: 2026 Latest Updates For Parents

ByHeart Formula Recall 2026 Info: What Parents Should Know

Disclaimer: This article mentions a ByHeart recall from 2025. For full transparency across all baby formula brands - we track historical baby formula recalls, regardless of formula brand. This article is a third party, non-affiliated explanation intended to help parents understand how recalls are tracked.

Every year, we, as parents, ask questions about high-quality formulas. Today, there are different options created for baby nutrition, and we're often concerned about recalls. Recalls naturally make us question the quality of organic formula and create worry about our babies' safety. In 2026, many of us are looking for information about ByHeart recalls. The brand has officially recalled products twice, raising some doubts about its quality. Any recall news – even for brands with good reputations – automatically raises concerns. We understand this anxiety because choosing the right formula feels like one of our most important parenting decisions.

News about recalls hits hard and affects brand reputation. We want to know exactly what happened and what caused these situations. Let's note two official recalls right away: the brand had recalls in 2022 and 2025. These baby product recalls occurred due to potential risks. However, there were no confirmed mass illnesses, and all recalls were under FDA control. Understanding these situations helps us rest easier. The brand continues to operate and produce quality products, demonstrating its commitment to safety improvements after each incident.

Understanding ByHeart Baby Formula and Its Safety Standards

Today, product recalls play a significant role in our decisions. We care deeply about our babies' health and strive to provide all necessary nutrients. To objectively assess recall issues, we need to understand the specific details of the ByHeart formula and why many parents choose it. The brand focuses on naturalness and increased quality control, positioning itself as a premium option in the infant formula market. Here are the main characteristics:

  • Designed for children from birth to six months (Stage 1) and from 6 to 12 months (Stage 2).
  • Formulas contain lactose as the main carbohydrate element – the basis found in breast milk.
  • Quality formulas in sustainable production contain appropriate levels of iron, prebiotics, DHA, and ARA.

The brand complies with FDA requirements and is manufactured in the USA under special regulations. There's increased control of nutritional composition and regular production inspections. Each batch undergoes testing and constant verification before release. Many parents ask, "Is ByHeart formula good?" and the answer is generally yes. Batches meet nutritional value standards and undergo microbiological control with clear traceability. The company invests heavily in quality assurance processes that go beyond basic regulatory requirements.

What Triggers a Baby Formula Recall in the U.S.?

The concept of a recall often leaves parents feeling dissatisfied and worried. Constant fear and doubt about formula quality can linger for years. Recalls signal a potential threat, but not always an actual threat to our children's health. Understanding why recalls occur helps put things in perspective. Today, baby formula recalls have these typical triggers:

  • Possible bacterial contamination.
  • Serious labeling errors without indicating ingredients.
  • Insufficient nutrient levels for children.
  • Violations of manufacturing standards, including sanitary regulations.
  • Potential risks for infants.

We should also understand two types of recalls that don't always mean children are harmed. There's a voluntary recall and an FDA-mandated recall – significantly different. The company initiates the first proactive step to preserve safety and brand trust. An FDA-mandated recall means the regulator requires action due to serious violations.

Recalls often concern specific batches due to particular threats. Most recalls don't mean all of a brand's products are unsafe. In fact, many recalled baby formulas happen as precautionary measures before any actual harm occurs. The system works as a protection mechanism. Here's how we learn about recalls:

  • Visit the FDA website for official information.
  • Learn through specialty stores and pharmacies.
  • Follow media coverage of all recalls.
  • Get notifications directly from the brand.

ByHeart Formula Recall History: Two Official Recalls

The brand's recall history includes only two officially recorded instances. The FDA documents both cases with official notifications. The ByHeart infant formula recalls have understandably caused anxiety among parents. Each case had particular characteristics and raised many questions. This recall history includes two confirmed instances over several years, emphasizing that these were targeted issues, not problems across all batches.

We should feel confident that the manufacturing process remains regulated. Everything is under control, with products being tested before release. The recall system works as protection, not a threat. It's worth noting that compared to some other formula brands, ByHeart's recall history remains relatively limited. Here's key data on these baby product recalls:

First recall:

  • Occurred on: December 11, 2022.
  • Product: Whole Nutrition Infant Formula, Milk-Based Powder with Iron.
  • Designed for: Infants from birth to 12 months.
  • Affected batches: 22273 C1, 22276 C1, 22277 C1, 22278 C1, 22280 C1.
  • Use by dates: 01 JAN 24 or 01 JUL 24.
  • Reason: Possible cross-contamination with Cronobacter sakazakii.

Second recall:

  • Occurred on: November 1, 2025.
  • Product: Whole Nutrition Infant Formula Stage 1 & Stage 2.
  • Format: Cans and single-serve sticks.
  • Lot codes: 206VABP/251261P2, 206VABP/251131P2.
  • Later expanded to all unexpired batches.
  • Reason: Risk of infant botulism.

Both cases of recalled baby formula were rare and had clear batch identification. They don't indicate systemic failure of this brand. These recalls show the control system works effectively. The FDA takes its responsibilities seriously and classifies such cases appropriately. However, they're controlled, which minimizes risks. For us parents, this means that formula remains a regulated, controlled product available to our babies.

Lot Numbers and Safety Details of the 2022 Recall

In 2022, the ByHeart recall raised significant concerns among parents like us. This alarm signal became a wake-up call about potential dangers. Many batches remained safe, but the situation had a profound impact. It showed us the importance of checking batch codes and understanding what recalls mean. This information helps us act correctly. Five batches were identified in the 2022 recall:

  • 22273 C1 - Use by: 01 JAN 24
  • 22276 C1 - Use by: 01 JAN 24
  • 22277 C1 - Use by: 01 JUL 24
  • 22278 C1 - Use by: 01 JUL 24
  • 22280 C1 - Use by: 01 JUL 24

These codes help us quickly identify whether our product falls under the recalled formula. We need to understand that if the code matches, the product cannot be used.

Let's talk about what Cronobacter sakazakii is and how it affects children's health. Cross-contamination means the potential presence of bacteria that can cause meningitis in infants and lead to sepsis. They're especially dangerous for children aged 2 to 3 months. While infections are rare, the consequences can be severe, which is why precautionary recalls matter so much.

We should check products correctly to minimize potential risks. Even though no illness cases were recorded, checking remains mandatory. Here's what we're advised to do:

  • Check the batch code at the bottom of the can.
  • Compare the code with the official ByHeart baby formula recall list.
  • Save the receipt and take a photo of the packaging.
  • Check messages on the FDA or brand website.
  • If we're unsure about the safety of our formula, contacting the pediatrician provides additional peace of mind.

Lot Numbers and Safety Details of the 2025 Recall

The second recall in 2025 was larger-scale and spread concern among many of us parents. This time, all unexpired batches of Stage 1 and Stage 2 were recalled, raising significant concerns about formula quality and safety. We began wondering, "Is ByHeart formula good?" and whether it's worth buying. Here are the initially affected batches:

  • 206VABP/251261P2
  • 206VABP/251131P2

The recall was then expanded to all non-expired batches. The main risk was possible contamination with spores that cause infant botulism. This leads to muscle weakness in children, swallowing difficulties, disrupted breathing, and reduced activity.

Even without confirmed cases, any risk is considered sufficient reason for recall. The precautionary nature of this recall demonstrates how seriously manufacturers and regulators take infant safety. We're advised to do the following:

  • Stop using the product immediately.
  • Keep the packaging and read the FDA instructions.
  • Contact the store or brand for information about the ByHeart formula.

Even if our baby feels well, risks may manifest later. Taking correct actions provides safety support and minimizes dangerous situations. The 2025 recall confirms the system works proactively, providing increased protection for our children even without confirmed threats or problems.

How ByHeart Responded and Improved Formula Safety

Two recall cases made clear that enhanced control is mandatory for maintaining parental trust. The main steps in both cases focused on improving safety and reducing the potential for repeat recalls. The brand remains stable in the market, offering consistent product quality and more transparent communication. We're seeing increased trust develop. The use of ByHeart infant formula has reached a new level through various quality maintenance approaches.

The brand uses these situations as opportunities for growth. Today, their formulas are considered high-quality products with increased constant control. Here's what became the driving factor after the two recalls:

  • After 2022: Expanded microbiological testing. Updated packaging lines. Enhanced supplier audits and internal checks. Implementation of additional safety protocols throughout production.
  • After 2025: Complete supply stop for investigation. Review of logistics chains. Full batch inspections. Additional laboratory control barriers for ByHeart baby formula. Third-party verification processes were added to existing quality measures.

How Parents Can Stay Informed About Future ByHeart Recalls

Even the best products can be recalled and become a potential threat. Your awareness directly affects your babies' health preservation. You can follow information on leading websites, such as the FDA website or the official brand website. Pediatric associations and reputable news media also help to stay informed. Subscribing to recall alerts ensures you receive notifications immediately rather than discovering issues later.

Product inspection is mandatory for maintaining our babies' health. You can find batch codes and compare them with recall databases. Keeping proof of purchase provides primary evidence in the event of violations. When the formula was recalled, we naturally questioned brand quality. However, the brand resumed operations with enhanced control measures in place.

This story includes two confirmed cases that are relatively rare in the market. Check manufacturers and read official reports. Consultation with the doctor is mandatory to protect babies' health and well-being. Staying aware helps to choose the right formulas for children, fostering confidence and peace of mind.

Latest recall

Recall Date: November 11, 2025

  • Product: ByHeart Whole Nutrition Infant Formula (cans and single-serve Anywhere Pack™ sticks) was voluntarily recalled nationwide due to potential infant botulism risk.
  • Affected lot codes to check: Look on the bottom of the can or pack for the following lot identifiers: 206VABP/251261P2 and 206VABP/251131P2 (Use by: Dec 1, 2026).
  • UPC codes: Cans are labeled with UPC 85004496800 and single-serve Anywhere Packs are labeled with UPC 85004496802.
  • Safety note: The recall was expanded to all batches after an ongoing multistate investigation linked infant botulism cases to the product, and parents are urged to stop using any ByHeart formula immediately.
  • What to do: Do not use any recalled formula; note the lot and UPC code before disposal or return, and watch infants for symptoms of botulism, seeking medical care if needed.

Source: FDA recall notice

Recall Date: December 11, 2022

  • Product: ByHeart Whole Nutrition Infant Formula (milk-based powder with iron for 0–12 months) was voluntarily recalled due to potential for Cronobacter sakazakii cross-contamination.
  • Affected batch codes: Printed on the bottom of the can, the recalled batches were 22273 C1, 22276 C1, 22277 C1, 22278 C1, and 22280 C1, with “Use by 01 JAN 24” or “01 JUL 24.”
  • Safety note: Although no illnesses were reported and no distributed product tested positive, Cronobacter can cause severe infections in infants, including sepsis and meningitis.
  • What to do: Consumers were advised to check the bottom of the can for the affected codes and dispose of any recalled product; contact a pediatrician with any health concerns.

Source: FDA recall notice

Additional Disclaimer: The information on this page is based on publicly available sources and is provided for general informational purposes only. We do not guarantee that all recall data is complete, current, or error-free, as manufacturers and regulators may issue updates at any time. This content is not medical, legal, or safety advice. Always verify recall information directly with the manufacturer, retailer, or official regulatory agencies, and consult a qualified healthcare professional if you have concerns about your child’s health.