What to Do If Your Child’s Medication Is Recalled

Medication recalls can be unsettling — here’s what parents need to know to protect their kids.

Introduction

Medication, product, and food recalls happen all too often nowadays. I’m glad there is a solid surveillance system to prevent harm, but it’s still a little unsettling. Parents also face a lot of information every day. It’s hard to stay informed, keep your sanity, and avoid stressing over every small thing.

This guide explains the recall process and provides tips to stay on top of recalls and safety issues in the pediatric world.

What a Recall Really Means

A drug recall happens when a company detects a manufacturing or safety problem and voluntarily removes the affected drug from the market. The Food & Drug Administration (FDA) can also ask a company to recall a drug, and it oversees the process.

Not all recalls are created equal. There are various types of recalls, from minor violations to those that could cause serious patient harm. For instance, some are due to contamination, while others involve mislabeling or expiration concerns. However, there have been cases of serious drug mix-ups and other critical safety issues.

If Your Child’s Medication Is Recalled

When the FDA announces a recall, they provide detailed information about the product — including the manufacturer, drug name, and batch (lot) number. You can find this information on the drug bottle.

You may have to look around a bit, because the font on a medication bottle can be small! Sometimes the batch number is not labeled as such; it's just a series of letters or numbers. It's often found near the product expiration date. If in doubt, check with your pharmacist.

If the recalled medication is a prescription that has been repackaged into a pharmacy bottle with a label (for example, an amber liquid bottle or orange pill bottle), the lot number may be harder to find. Pharmacy labels don't always include lot numbers.

The pharmacy tracks this and should reach out to you in the event of a recall, but you can always call and ask if your prescription is affected!

If your batch is affected:

• Stop using the medication immediately.
• Follow the recall instructions provided by the manufacturer or FDA. This may involve discarding the item, mailing it to the company, or returning it to the store where it was purchased.

Not all recalls make the news. Only those that could harm patients or are widely distributed tend to be publicized. However, all recalls are recorded with the FDA. You can view them on the FDA’s weekly recall report or subscribe to email updates.

What to Do After a Children’s Medication Recall

• Call your child’s pharmacy or pediatrician to arrange an alternative medication.
• Report any side effects or concerns to your child’s doctor.
• Store the recalled medication safely until you receive instructions on how to dispose of or return it.

Other Children’s Product Recalls

Many regulations surround children’s products. The U.S. Consumer Product Safety Commission (CPSC) oversees product safety and manages recalls for children’s toys, gear, and other items. The CPSC also offers an email subscription service so you can receive updates directly.

Whenever you buy a safety-related children’s product — like a car seat, high chair, or crib — always fill out the recall registration card that comes with it. This ensures you’ll be notified if a recall is issued.

Conclusion

Parenting today isn’t easy. We have access to lots of information and are aware of many risks — it can be overwhelming and make you feel like you’re missing something. Take advantage of recall alerts from organizations like the FDA and CPSC. That’s one less thing to worry about on your mental safety checklist!

If your child’s medication gets recalled, verify the lot number. If your product is affected, stop using it immediately and consult your pediatrician or pharmacist for guidance.

The following references were used to compile this information:

Affairs, O. of R. (2019). Recalls Background and Definitions. FDA. https://www.fda.gov/safety/industry-guidance-recalls/recalls-background-and-definitions

Affairs, O. of R. (2025, May 28). Enforcement Reports. FDA; FDA. https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/enforcement-reports

FDA’s Role in Drug Recalls | FDA. (n.d.). Retrieved August 14, 2025, from https://www.fda.gov/drugs/drug-recalls/fdas-role-drug-recalls

Recalls & Product Safety Warnings. (n.d.). U.S. Consumer Product Safety Commission. Retrieved August 14, 2025, from https://www.cpsc.gov/Recalls