What to Do with Recalled Formula?

At its foundation baby formula is food. This may seem obvious on paper, but parents often don’t realize that formula usage comes with an inherent risk of recalls, just like we find with all other food products. While infant formula is the most highly-regulated food product on the market given the inherent vulnerability of its consumers– infants with brand new immune systems– a baby formula recall can and will happen.

Read on for a discussion of why recalls occur, what prompts them, and what to do if you face this situation with your baby’s formula product.

Why do recalls happen?

Recalls are a rare but an expected part of the manufacturing process. While these events can be concerning for parents, it’s important to remember that recalls demonstrate that safety policies are working as intended to keep the consumer safe. For infant formula, a recall happens when a possible, probable, or potential risk to health is identified.

Common reasons behind infant formula recalls include:

• Improper can or container labeling
• Packaging defects
• Potential inclusions (i.e. plastic, metal)
• Potential bacterial contamination
• Inappropriate nutrient levels
• Lack of proper FDA registration

What is a “voluntary recall”?

Most infant formula recalls are voluntary. A voluntary recall occurs when a manufacturer decides to pull product from distribution out of an abundance of caution and to encourage consumers to stop using a product based on their assessment of a potential risk. Conversely, a non-voluntary recall occurs when the FDA requires a company to stop distribution.

Rest assured that voluntary recalls are still made in coordination with FDA guidance and oversight. 

Why is formula being recalled?

Most often, customers will hear from the manufacturer directly via a website alert or through other company distribution channels such as text, email, or social media. The FDA will also issue an alert of the recall and share to their channels, most notably Twitter and to email alert subscribers. The manufacturer will typically establish a webpage with information about what prompted the recall, how to assess whether any products a consumer has on hand are affected, and what to do if so. 

If you are made aware of a recall by a manufacturer whose products you use, you should visit both the manufacturer’s and FDA’s press releases to view lot or batch numbers for affected products.  Compare the lot or batch number on your formula products (typically printed on the bottom of the container) to the recalled numbers provided by the company and FDA. If the lot or batch numbers match, the product(s) are part of the recall. If numbers do not match, the product is not part of the recall and may continue to be used.

What do I do with recalled formula products?

If you have products on hand that are part of an infant formula recall, you should take the following steps:

• Stop using the product(s) immediately!
• Review the manufacturer’s and FDA’s alerts to determine what to do with the recalled product(s). Manufacturers may recommend tossing the products, or may suggest storing them in a safe space until a refund has been issued or in case a sample is needed for microbial testing later (this can be particularly important if an infant has been hospitalized)
• Contact the manufacturer to report the recalled products and request a refund using instructions provided on manufacturer’s website
• Keep an eye out for symptoms of illness: fever, lethargy, gastrointestinal distress, poor feeding

Reporting Adverse Events

Both the manufacturer and the FDA will request that any adverse events that may be related to a recalled product be reported. First, report any symptoms that could be related to a recalled product to your child’s pediatrician as they can help assess and provide treatment instructions. If indicated or desired, consumers can call an FDA Consumer Complaint Coordinator to speak directly to a person about the problem. Consumers may also complete an electronic Voluntary MedWatch form online or submit a paper Voluntary MedWatch form that can be mailed to the FDA.

How do I find a new product to use if my formula was recalled?

It is important to stop using a recalled product immediately even if you’re unsure of what to use in its place. It is not recommended by any health authority to continue to use a recalled formula even if additional safety measures (such as sterilizing powdered formula with boiled water) are taken!

Instead, you’ll want to identify a new formula that is similar in composition to the recalled formula, particularly with regard to key ingredients. This can make for an easier transition for your baby and reduce the likelihood of an adverse reaction during the transition. For example:

• If the recalled product has lactose as the carbohydrate source, it’s best to find a new formula that also uses lactose.
• If the recalled product has extensively hydrolyzed hypoallergenic proteins, it’s best to find a new formula that also features extensively hydrolyzed hypoallergenic proteins.

How do I introduce a new formula?

Remember, if you have formula from the same brand that is NOT part of a recalled lot you can continue to use it! There is no need to switch to a new brand if you have unaffected formula on hand. If you need to switch due to a recall, switch immediately to a new product for the next feeding.  Do not continue to use a recalled product in order to provide a “slow” or “gradual” transition! It’s recommended to switch “cold-turkey” to a similar, unaffected product.

It’s important to note that an adjustment period is normal when switching to a new baby formula. Changes in baby’s stool color, texture, or frequency, or an increase in gas or reflux can be common during the first few days on a new product. Consult with your child’s doctor with questions or concerns about any symptoms you notice during the transition period.

How long do recalls last?

The amount of time that a recall may affect consumers varies based on a number of factors, including whether manufacturing is shut down to investigate the cause of the concern or whether existing product is simply withdrawn from the market. Consumers should follow the manufacturer’s communication channels closely as they should communicate with the consumer when new or replacement product is or will be available. The FDA may also release an update to the recall notice on their website with additional findings and/or when their investigation is complete.

Remember, recalls exist to keep consumers safe!

While recalls can be frustrating and concerning as a consumer, especially when they occur with a baby’s sole source of nutrition, recalls are an important food safety guardrail. With a population as vulnerable as brand-new babies, it is important for brands to operate with caution even if it means risking upset among consumers. The health of infants must always take priority, even when a recall creates a challenge for parents! With recall policies in place as part of broader operational food safety guidelines, parents can feel confident using formula to feed their babies if desired or required.