Baby Formula Recalls and Safety Alerts

Abbott is recalling powder formulas, including Similac, Alimentum, and EleCare, that were manufactured in Sturgis, Mich.

The firm has received complaints related to Cronobacter sakazakii or Salmonella Newport in infants

Cronobacter sakazakii can cause fever, poor feeding, excessive crying, or low energy in infants.

The recalled products have a multidigit number on the bottom of the container starting with the first two digits 22 through 37. They also contain K8, SH, or Z2 and have an expiration date of April 1, 2022, or after.

What to do

Consumers should visit similacrecall.com and type in the code on the bottom of the package, or call (800) 986-8540 and follow the instructions provided, to find out if the product they have is included in this recall.

The U.S. Food and Drug Administration (FDA) is cautioning people that powdered infant formulas manufactured at Abbott Nutrition’s Sturgis, Mich., facility may cause Cronobacter sakazakii or Salmonella Newport infection in infants. 

The agency stated that there have been four cases linked to Cronobacter symptoms in which infants were hospitalized, with one case resulting in death. The infections were found in Minnesota, Ohio, and Texas.

Salmonella Newport is a common bacteria that has most often been connected to papayas, but it has also shown up in beef products. Cronobacter sakazakii, on the other hand, is a more serious bacteria. It has been connected to powdered milk, herbal teas, starches, vegetables, and even tampons.

The Centers for Disease Control and Prevention (CDC) says Cronobacter can cause diarrhea and urinary tract infections in people of all ages, but infection can be very serious in infants. The CDC says the first symptom of Cronobacter infection in infants is usually a fever, accompanied by poor feeding, crying, or very low energy. Anyone who has an infant displaying these symptoms should take them to a doctor.

What products are recalled?

The Cronobacter sakazakii infections have been connected to Abbott Nutrition's facility in Sturgis, Mich., but the company reports that it found no evidence of Salmonella Newport.

"Importantly, no distributed product has tested positive for the presence of either of these bacteria, and we continue to test,” Abbott Nutrition said in a news release. 

Recalled powdered infant formula includes the brand names Similac, Alimentum, and EleCare. The first two digits of the product codes of the recalled products range from 22 through 37, and the code on the container contains “K8,” “SH,” or “Z2.” All recalled products have an expiration date of April 1, 2022, or later. Abbot said no other Abbott liquid formulas, powder formulas, or nutrition products from other facilities are impacted by the recall. 

The FDA warns consumers who have a recalled product to not feed it to their infant. Instead, they should throw it away or return it for a refund. Concerned consumers should visit the FDA’s website for more information.

Consumers can check the safety of their product by visiting similacrecall.com and typing in the code on the bottom of the product package, or they can call +1-800-986-8540 and follow the instructions provided. 

CDC suggests breastfeeding

Having been down the Cronobacter road before, the CDC says the best way to protect an infant from the bacteria is breastfeeding.

“Breastfeeding is one of the best things you can do for your baby’s health and development,” the CDC says. “Among its benefits: preventing different kinds of infections, such as ear and respiratory infections. Very few cases of Cronobacter infections have been reported among infants fed only breast milk.”

If breastfeeding isn’t a viable option, the CDC says caregivers should use liquid formula instead of powdered formula because the latter is not sterile.

“This is especially important when your baby is less than 3 months old or if your baby was born prematurely or has a weakened immune system. Liquid infant formula is made to be sterile (without germs) and should not transmit Cronobacter infection when handled carefully,” the agency suggests.

Moor Herbs of Detroit, Mich., is recalling Angel Formula infant formula.

FDA testing has determined that the product does not meet specific nutrition and labeling requirements for infant formula, even though it is marketed as such.

In addition, the product does not have vitamin D, and a vitamin D deficiency can potentially lead to rickets, a softening and weakening of the bones.

No illnesses or injuries have been reported to date.

The recalled product, which comes in 16-oz plastic bottles without UPC or lot codes, was sold at the company's Detroit, Michigan, retail store and on the firm's website

What to do

Parents and caregivers who purchased the recalled product should discontinue use and either discard it or return it for a refund.

Consumers with questions may call (313) 583-9709.

Able Groupe is recalling products used as infant formulas, intended as a complete or partial substitute for human milk for children 12 months old and younger.

The products have insufficient iron levels required for infant formula in the U.S., and do not meet other FDA requirements.

A list of the recalled products, imported from Europe and sold to consumers by mail, may be found here.

The products were not available at any retail store.

What to do

Customers who purchased the recalled products should not use them as infant formula, but discard them immediately

Consumers with questions may contact the company by email at recallquestions@ablegroupe.com

Designed By Nature of California is recalling its Goat’s Milk Powder, Cow’s Milk Powder and Base Milk Powder formulas.

The firm intends to change the labeling to make it clear that these products are not intended to be used as infant formula.

There are no reports of injury or illness to date.

The recalled products, with an expiration date between May 1, 2021, thru June 11, 2022, with a label on the bottom of the pouch with a lot number and expiration date, were sold only online and shipped directly to consumers

What to do

Parents and caregivers of infants 12 months and younger should not use the recalled products as they are deficient in multiple nutrients required for infant formula, and have not been tested for the presence of Cronobacter, a pathogen that can be particularly dangerous to infants, and is required testing for powdered infant formula.

Consumers with question may contact the firm at https://designed-by-nature.com/pages/contact-us.

Perrigo Company is recalling 23,388 35-oz. (992-gram ) containers of Parent's Choice Advantage Infant Formula Milk-Based Powder with Iron.

The product may be contaminated with pieces of metal

No adverse events have been reported to date.

The product was sold exclusively at Walmart stores nationwide

What to do

Customers who purchased the recalled product should look for Lot Code C26EVFV with a "use by" date of February 26, 2021, on the bottom of the package.

Use of the recalled product should be discontinued, with the product returned to any Walmart store for a refund.

Consumers with questions may contact Perrigo at (866) 629-6181.

The Food and Drug Administration (FDA) is putting the finishing touches on a rule that sets standards for manufacturers of infant formula.

In light of comments received after the interim rule published last February, the final rule provides some modifications and clarifications, and sets a date of September 8, 2014, for manufacturer compliance.

Formula standards

Under the final rule, standards include:

• Current good manufacturing practices specifically designed for infant formula -- including required testing for the harmful pathogens (disease-causing bacteria) Salmonella and Cronobacter.
• A requirement that manufacturers demonstrate that the infant formulas they produce support normal physical growth.
• A requirement that infant formulas be tested for nutrient content in the final product stage, before entering the market, and at the end of the products’ shelf life.

“FDA sets high quality standards for the safety and nutritional quality of infant formulas during this critical time of development,” says Stephen Ostroff, M.D., FDA’s acting chief scientist.

The final rule applies only to infant formulas intended for use by healthy infants without unusual medical or dietary problems. The agency notes that many companies now manufacturing infant formula for the U.S. market have been producing safe products and have voluntarily applied many of the current good manufacturing practices and quality control procedures included in the final rule.

But this rule will set in place federally enforceable requirements for the safety and quality of infant formula.

FDA does not approve infant formulas before they can be marketed. However, all formulas marketed in the U.S. must meet federal nutrient requirements, which are not changed by the new rule. Infant formula manufacturers are required to register with FDA and provide the agency with a notification prior to marketing a new formula.

FDA conducts yearly inspections of all facilities that manufacture infant formula and collects and analyzes product samples. FDA also inspects new facilities. If FDA determines that an infant formula presents a risk to human health, the manufacturer of the formula must conduct a recall.

Products on the market

While breastfeeding is strongly recommended and many mothers hope to breastfeed their infants, most infants in the U.S. rely on infant formula for some portion of their nutrition. An estimated 1 million infants in the United States are fed formula from birth, and by the time they are 3 months old, about 2.7 million rely on formula for at least part of their nutrition.

Infant formula comes in three forms:

• Powder -- the least expensive of the infant formulas. It must be mixed with water before feeding.
• Liquid concentrate -- must be mixed with an equal amount of water.
• Ready-to-feed -- the most expensive form of formula that requires no mixing.

The protein source varies among different types of infant formula.

FDA’s nutrient specifications for infant formulas are set at levels to meet the nutritional needs of infants. In addition, formula manufacturers set nutrient levels that are generally above the FDA minimum requirements. Thus, babies fed infant formulas do not need additional nutrients unless they are fed a low-iron formula.

The infant formulas currently available in the United States are either “iron-fortified”—with approximately 12 milligrams of iron per liter—or “low iron”—with approximately 2 milligrams of iron per liter. The American Academy of Pediatrics (AAP) recommends that formula-fed infants receive an iron-fortified formula as a way of reducing the prevalence of iron-deficiency anemia.

Safety issues

Here are some simple steps caregivers can take to make sure their formula is safe:

• Formula preparation. In most cases, it’s safe to mix formula using ordinary cold tap water that’s boiled for one minute and cooled. Formula made with hot water needs to be cooled quickly to body temperature -- about 98 degrees Fahrenheit -- if it is to be fed to the baby immediately. If the formula is not being fed immediately, refrigerate it right away and keep refrigerated until feeding.
• Bottles and nipples. The Mayo Clinic says you may want to consider sterilizing bottles and nipples before first use. After that, you can clean them in the dishwasher or wash them by hand with soapy water.
• Water. Use the exact amount of water recommended on the label.
• Formula warming. This isn’t necessary for proper nutrition. The best way to warm a bottle of formula is by placing the bottle in a pot of water and heating it on the stove until warm (at body temperature). Never use microwave ovens for heating infant formulas. Microwaving may cause the bottle to remain cool while hot spots develop in the formula. Overheated formula can cause serious burns to the baby.
• “Use by” date. This is the date after which a package or container of infant formula should not be fed to infants. It indicates that the manufacturer guarantees the nutrient content and the general acceptability of the quality of the formula up to that date. FDA regulations require this date to be specified on each container of infant formula.
• Storage. Manufacturers must include instructions on infant formula packaging for its handling before and after the container is opened. They must also include information on the storage and disposal of prepared formula.
• Freezing formula. This is not recommended, as it may cause a separation of the product’s components.