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FDA Pediatric Safety Communications

The FDA monitors the safety of the products we regulate. When new or concerning trends about a product’s safety are identified, the FDA shares this information in online safety communications, recalls, public health alerts, press releases and other communication channels.

The searchable table below shows a list of recent safety communications that are relevant to children. 

For a more complete listing of all safety communications, recalls, public health alerts and press releases, see the resources links below.

DateProduct(s)New Safety Issue or UpdateAnnouncementProduct Type
June 6, 2025Zicam® Cold Remedy Nasal Swabs, Zicam® Nasal AllClear Swabs, and Orajel™ Baby Teething SwabsNewFDA reports that Church & Dwight Co., Inc. has issued a voluntary nationwide recall of Zicam® Cold Remedy Nasal Swabs, Zicam® Nasal AllClear Swabs, and Orajel™ Baby Teething Swabs due to microbial contaminationDrugs
May 16, 2025Cetirizine or levocetirizine (Zyrtec, Xyzal, and other trade names)NewFDA requires warning about rare but severe itching after stopping long-term use of oral allergy medicines cetirizine or levocetirizine (Zyrtec, Xyzal, and other trade names)Drugs
March 11, 2025Limited number of acne products containing benzoyl peroxideNewFDA alerts the public and industry that a limited number of voluntary recalls have been initiated after FDA testing of acne products for benzene; findings show a small number of products with elevated levels of benzene contaminationDrugs
February 5, 2025Diabetes-related smartphone device alert settingsNewFDA alerts patients to regularly check diabetes-related smartphone device alert settings, especially following phone hardware or software changesMedical Devices
January 31, 2025Gerber® Soothe N Chew® Teething SticksNewFDA reports that Gerber Products Company announces recall and discontinuation of all batches of Gerber® Soothe N Chew® Teething Sticks due to choking hazardHuman Foods
January 16, 2025Neonatal incubatorsUpdateFDA provides an update: Evaluation of airborne chemicals from neonatal incubators - Letter to Health Care ProvidersMedical Devices
December 5, 2024E-cigarettesNewFDA warns more than 100 retailers for illegal sale of youth appealing e-cigarettes, including Geek BarTobacco Products
October 30, 2024Disposable e-cigarettes with designs and functionalities that resemble smart technology, including phones and gaming devicesNewFDA warns firms illegally selling e-cigarettes resembling products with smart technology, including phones and gaming devicesTobacco Products
October 28, 2024Dynacare Baby PowderUpdateFDA reports that Dynarex Corporation is expanding a recall to include additional products due to possible health riskCosmetics
October 17, 2024Medtronic MiniMed 600 and 700 Series insulin pumpsNewFDA reports an insulin pump recall: Medtronic notifies users of MiniMed 600 and 700 Series pumps of risk of shorter than expected battery lifeMedical Devices
October 15, 2024Zyno Medical Z-800, Z-800F, Z-800W, and Z800WF infusion pumpsNewFDA reports an infusion pump recall: Zyno Medical removes Z-800, Z-800F, Z-800W, and Z800WF infusion pumps due to an air-in-line software defect that may allow larger than expected air bubbles to enter patientsMedical Devices
October 7, 2024Happy Moose Juice Tropical Roots and Happy Moose Strawberry FieldsNewFDA reports that Youngstown Grape Distributors Inc. is recalling Happy Moose Juice Tropical Roots and Happy Moose Strawberry Fields because of possible health riskHuman Foods
October 7, 2024Philips Respironics Trilogy Evo, Trilogy Evo O2, Trilogy Evo Universal, and Trilogy EV300 ventilatorsNewFDA reports that Philips Respironics has issued additional usage instructions for Trilogy Evo ventilators related to use of in-line nebulizersMedical Devices
September 5, 2024FreeStyle Libre® 3 sensorsUpdateFDA reports continuous glucose monitoring (CGM) sensor recall: Abbott Diabetes Care Inc issues recall for certain FreeStyle Libre 3 sensors due to risk for inaccurate high glucose readingsMedical Devices
September 4, 2024Bivona® Tracheostomy TubesNewFDA reports that Smiths Medical issues urgent medical device notification informing customers of a potential issue with certain Bivona® Tracheostomy TubesMedical Devices
August 28, 2024Version 2.7 of the Apple iOS t:connect Mobile App used in conjunction with t:slim X2 Insulin Pump with Control-IQ TechnologyUpdateFDA reports that Tandem Diabetes Care, Inc. is recalling version 2.7 of the Apple iOS t:connect mobile app used in conjunction with t:slim X2 Insulin Pump with Control-IQ Technology prompted by a software problem leading to pump battery depletionMedical Devices
August 15, 2024Apple cinnamon fruit puree pouchesNewFDA issues warning letter to Austrofood and continues robust activities to ensure safety of cinnamon products sold in U.S.Human Foods
August 9, 2024Vivo 45 LS VentilatorNewFDA reports that Breas Medical is issuing a voluntary U.S. nationwide urgent medical device correction of Vivo 45 LS VentilatorMedical Devices
August 8, 2024CVS Health, H-E-B Baby infant formulaNewFDA reports that Perrigo is issuing a voluntary recall of one batch of premium infant formula with iron milk-based powder due to elevated levels of Vitamin DInfant Formula
August 1, 2024Geek Bar, Lost Mary, and BangNewFDA warns online retailers selling unauthorized youth appealing e-cigarettesTobacco Products
July 31, 2024MEGA SOFT™, MEGA SOFT DUAL™ and MEGA 2000™ Patient Return ElectrodesUpdateFDA raises awareness about safe use of Megadyne Mega 2000 and Mega Soft Patient Return Electrodes - Letter to Health Care ProvidersMedical Devices
July 22, 2024Acetaminophen Injection 1,000 mg per 100 mL (10 mg/mL) 100 mLNewFDA reports that Hikma Pharmaceuticals USA Inc. is extending the voluntary nationwide recall of one lot of acetaminophen injection, 1000mg/100mL, (10mg/mL) bags due to an individual unit of acetaminophen overwrap found to have contained a labelled bag of dexmedetomidine HCL injection (400mcg/100mL)Drugs
June 4, 2024Crecelac Infant 0-12 Infant Formula (Lot # 24 039 1 CHE 352-1)UpdateFDA reports that Dairy Manufacturers Inc. is notifying consumers about a safety concern with Crecelac Infant 0-12 Infant Formula (Lot # 24 039 1 CHE 352-1) that is part of an ongoing recall – Expansion of Previous RecallInfant Formula
October 16, 2024Cue Health COVID-19 testsUpdateFDA warns home test users, caregivers, and health care providers not to use Cue Health’s COVID-19 tests due to risk of false resultsMedical Devices
May 10, 2024Healthwest Minerals Inc. DBA Mt Capra Products Goat Milk Formula Recipe KitNewFDA reports that Healthwest Minerals Inc. DBA Mt Capra Products is recalling Goat Milk Formula Recipe Kit and warns consumers against the use of product as infant formulaInfant Formula
April 18, 2024Sammy’s Milk Goat Milk Toddler FormulaNewFDA asks Sammy’s Milk to provide a warning against the use of Goat Milk Toddler Formula as infant formulaInfant Formula
February 29, 2024Care Plus, Care Plus models 1000-4000 and Lullaby incubatorsNewFDA reports that Wipro GE Healthcare Private Ltd. is recalling Care Plus, Care Plus models 1000-4000 and Lullaby incubators due to problems with door latchMedical Devices
February 19, 2024Nordic Naturals Baby’s Vitamin D3 Liquid,NewFDA reports that Nordic Naturals has issued a voluntary recall of Baby's Vitamin D3 Liquid due to elevated levels of vitamin D3Dietary Supplements
August 15, 2024Recalled WanaBana apple cinnamon fruit puree pouches- including three packs, Recalled Schnucks-brand cinnamon-flavored applesauce pouches and variety pack, Recalled Weis-brand cinnamon applesauce pouchesUpdateFDA reports that recalled cinnamon apple puree and applesauce products containing lead test positive for chromiumHuman Foods
December 31, 2023Select batches of Nutramigen hypoallergenic infant formula powderNewFDA reports that Reckitt/Mead Johnson Nutrition has voluntarily recalled select batches of Nutramigen hypoallergenic infant formula powder because of possible health riskInfant Formula
December 14, 2023Levetiracetam (Keppra, Keppra XR, Elepsia XR, Spritam) and clobazam (Onfi, Sympazan)NewFDA warns of rare but serious drug reaction to the antiseizure medicines levetiracetam (Keppra, Keppra XR, Elepsia XR, Spritam) and clobazam (Onfi, Sympazan)Drugs
November 28, 2023BCMA-directed or CD-19-directed autologous chimeric antigen receptor (CAR) T cell immunotherapiesNewFDA is investigating serious risk of T-cell malignancy following BCMA-directed or CD19-directed autologous chimeric antigen receptor (CAR) T cell immunotherapiesBiologics
November 1, 2023Moderna COVID-19 vaccine (2023-2024 Formula)NewFDA advises health care providers about the correct dosage and administration of Moderna COVID-19 Vaccine (2023-2024 Formula) for individuals 6 months through 11 years of ageVaccines
October 26, 2023ProbioticsUpdateFDA raises concerns about probiotic products sold for use in hospitalized preterm infants. Dietary Supplements
September 14, 2023LittleOak infant formulaNewFDA alerts parents and caregivers to concerns regarding LittleOak Infant FormulaInfant Formula

September 13, 2023
TheraBreath Strawberry Splash for Kids 16ozNewFDA reports that Church & Dwight issues voluntary nationwide recall of one specific lot of TheraBreath Strawberry Splash for Kids 16oz sold exclusively on Amazon Between May 31 and September 02, 2023, due to microbial contamination identified as yeast (candida parapsilosis)Human Foods
September 29, 2023Certain O&M Halyard surgical N95 respirators, surgical masks, and pediatric face masksUpdateFDA provides an update on recommendations for certain O&M Halyard surgical N95 respirators, surgical masks, and pediatric face maskMedical Devices
August 1, 2023GoHealthy probiotics for infants, toddlers and kids in 2-ounce bottles and GoHealthy probiotics for infants, kids, men and women in 4-ounce bottlesNewFDA reports that Ozona Organics issues voluntary recall of select liquid probiotic products due to possible health riskDietary Supplements
July 13, 2023NOxBOXi Nitric Oxide SystemNewFDA reports that NOxBOX Ltd. is recalling NOxBOXi Nitric Oxide System for manifold failure that may cause gas leaks and interrupt therapy to neonatesMedical Devices
July 7, 2023Albuterol Sulfate Inhalation Aerosol, 90 mcg (200 Metered Inhalation)NewFDA reports that Cipla issues voluntary nationwide recall of six batches of Albuterol Sulfate Inhalation Aerosol, 90 mcg (200 Metered Inhalation) due to container defectDrugs
June 22, 2023Elf Bars and Esco Bars e-cigarettesNewFDA inspection blitz leads to more than 180 warning letters to retailers for the illegal sale of youth-appealing Elf Bar and Esco Bars e-cigarettesTobacco Products

Resources

Pediatric Medical Product Safety | FDA 
Recalls, Market Withdrawals, & Safety Alerts | FDA 
Additional Information about Recalls | FDA 
Medical Device Safety | FDA
MedWatch: The FDA Safety Information and Adverse Event Reporting Program | FDA 
Safety & Availability (Biologics) | FDA
Recalls (Biologics) | FDA 
Tobacco Product Problem Reports | FDA

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