Baby and kids' product recalls

6672 federal recalls on file. Every federal recall touching baby and kids' products — toys, formula, baby food, cribs, strollers, child seats. Sourced from CPSC, FDA, USDA, and NHTSA, translated into plain English.

2020-04-08FDA-FoodNutraBlend Foods, Inc. LLCClass III
Russian Bear 10000 Weight Gainer Formula Vanilla packed in 15lb bags
Products contain undeclared soy protein isolate.
2020-04-08FDA-DrugY-O Management LLC, dba Natural Remedy StoreClass I
Natural Remedies Active Male 500 mg Male Pleasure Formula Dietary Supplement Manufactured For: Natural Remedies San Antonio, TX, USA 1(877)543-3501
Marketed without an Approved NDA/ANDA: FDA analysis found this product to contain undeclared Tadalafil, an FDA approved drug for the treatment of erectile dysfunction
2020-04-08FDA-DrugPar Pharmaceutical Inc.Class II
Glycopyrrolate Tablets, USP 1 mg, 100-count bottle, Rx only, Dist. by: Par Pharmaceutical, Chestnut Ridge, NY, 10977, U.S.A, Mfg. by: Par Formulations Private Limited, 1/58, Pudupakkam, Kelambakkam - 603 103., Made in India NDC# 49884-0065-01
Failed Impurities/Degradation Specification: Presence of unknown impurity observed.
2020-04-06CPSCJoybird, of Commerce, Calif.
Joybird Recalls Dressers Due to Tip-Over and Entrapment Hazards
The recalled dressers are unstable if not anchored to the wall, posing tip-over and entrapment hazards that may result in death or serious injuries to children. The dressers do not comply with the performance requirements of the U.S. voluntary industry standard (ASTM 2057-17).
2020-04-02CPSCThe Manhattan Toy Company LLC, of Minneapolis, Minn.
Manhattan Toy Recalls Musical Lili Llama Due to Choking Hazard
The screws used to attach the spinning flowers to the sides of the toy can become loose and fall off, posing a choking hazard for young children.
2020-04-01FDA-DeviceSiemens Healthcare Diagnostics, Inc.Class II
ADVIA Chemistry Total Bilirubin_2 assay- SMN: 10341115 (40 mL) & 10341113 (70 mL). Product Usage: ADVIA TBIL_2 is for in vitro diagnostic use in the quantitative determination of total bilirubin in human serum and plasma of adults and neonates on the ADVIA¿ Chemistry systems. Measurement of total bilirubin, an organic compound formed during the normal and abnormal destruction of red blood cells, is used in the diagnosis and treatment of liver, hemolytic, hematological, and metabolic disord
Bilirubin assays may exhibit a positive bias with patients on eltrombopag therapy
2020-04-01FDA-DeviceSiemens Healthcare Diagnostics, Inc.Class II
Atellica CH Total Bilirubin_2 assay-In vitro Diagnostic for the determination of total bilirubin SMN: 11097531 - Product Usage: Atellica TBil_2 assay is for in vitro diagnostic use in the quantitative determination of total bilirubin in human serum and plasma (lithium heparin) of adults and neonates using the Atellica¿ CH Analyzer. Measurement of total bilirubin, an organic compound formed during the normal and abnormal destruction of red blood cells, is used in the diagnosis and treatment of
Bilirubin assays may exhibit a positive bias with patients on eltrombopag therapy
2020-04-01FDA-FoodOrganic By Nature, Inc.Class III
Nested Naturals Super Kids; Superfood Powder Full of Nutrients for Growing Bodies; Whole Food Powder, Net Wt. 7.5 oz (210g), 30 servings; Finished Product Item # FNNKFMSG210G; Bulk Finished Product Item # FGBPNNKFMSG Distributed by Nested Naturals Vancouver, BC, Canada
Firm was notified by supplier that Organic Ground Flaxseed powder was under recall by manufacturer due to unapproved herbicide - Haloxyfop
2020-04-01FDA-DrugGlaxosmithkline Consumer Healthcare HoldingsClass II
Ibuprofen 50 mg per 1.25 mL Oral Suspension Advil Infant Concentrated Drops White Grape 0.75 oz. and 1 oz. bottles NDC 0573-0191-75 (0.75 oz.) NDC 0573-0191-50 (1 oz.)
Labeling: Lacks Warning or Rx Legend- Certain lots does not include required safety warning information in the Drug Facts Panel.
2020-03-25FDA-DrugMed Man Distribution, Inc.Class I
UP2, Dietary Supplement, All Natural Libido for Men & Women, a) one pack, b) four pack, c) ten pack capsules per carton, Exclusively Manufactured and Formulated by: Buy Wise Marketing, 4234 I-75 Business Spur, Sault Ste Marie, MI 49783, Ultimatepleasure2.com.
Marketed without an Approved NDA/ANDA: Product contains undeclared sildenafil which was discovered through FDA analysis.
2020-03-19CPSC
Kids & Koalas Baby Walkers Recalled Due to Fall and Entrapment Hazards; Sold Exclusively on Amazon.com (Recall Alert)
The baby walkers fail to meet the federal safety standard. Specifically, they can fit through a standard doorway and are not designed to stop at the edge of a step as required by the federal safety standard and they have leg openings that allow the child to slip down until the child's head can become entrapped at the neck. Babies using these walkers can be seriously injured or killed.
2020-03-19CPSCWenzhou Jinlong Shoes Co., of China
Lilly of New York Children's Winter Boots Recalled by Kidz Concepts Due to Violation of Federal Lead Content Ban; Sold Exclusively at Zulily.com (Recall Alert)
The boots' sole contain levels of lead that exceed the federal lead content ban. Lead is toxic if ingested by young children and can cause adverse health issues.
2020-03-19CPSCPlant Therapy LLC, of Twin Falls, Idaho
Plant Therapy Recalls Wintergreen Essential Oils and Essential Oil Blends with Wintergreen Due to Failure to Meet Child Resistant Packaging Requirement; Risk of Poisoning (Recall Alert)
The products contains the substance methyl salicylate which must be in child resistant packaging as required by the Poison Prevention Packaging Act (PPPA). The packaging of the products is not child resistant, posing a risk of poisoning if the contents are swallowed by young children.
2020-03-19CPSCGrizzly Industrial Inc., of Bellingham, Wash.
Children's Tool Kits Recalled by Grizzly Industrial Due to Violation of Federal Lead Content Ban and Toy Safety Requirements
The tool belt, hammer and suspenders (model H3044) contain excessive levels of lead, violating the federal lead content standard. In addition, the toy goggles and hardhats do not meet toy safety requirements.
2020-03-19CPSCThule Group, of Sweden
Thule Recalls Thule Sleek Car Seat Adapters Due to Fall Hazard
The plastic brackets on the car seat adapter can break, posing a fall hazard to infants.
2020-03-18CPSCButterfly Express, of Clifton, Idaho
Earth Sonnets Recalls Wintergreen Essential Oil Due to Failure to Meet Child Resistant Packaging Requirement; Risk of Poisoning (Recall Alert)
The product contains the substance methyl salicylate which must be in child resistant packaging as required by the Poison Prevention Packaging Act (PPPA). The packaging of the product is not child resistant, posing a risk of poisoning if the contents are swallowed by young children.
2020-03-18CPSCSeeNext Venture Ltd., of Blaine, Wash.
NumbSkin Pain Relief Cream Recalled by SeeNext Venture Due to Failure to Meet Child Resistant Packaging Requirement; Risk of Poisoning (Recall Alert)
The packaging is not child resistant as required by the Poison Prevention Packaging Act. The pain relieving cream contains lidocaine, posing a risk of poisoning to young children if they put it on their skin or ingest it.
2020-03-18CPSCEarthroma LLC, of Fayetteville, Arkansas
Earthroma Recalls Wintergreen Essential Oil Due to Failure to Meet Child Resistant Packaging Requirement; Risk of Poisoning (Recall Alert)
The product contains the substance methyl salicylate which must be in child resistant packaging as required by the Poison Prevention Packaging Act (PPPA). The packaging of the product is not child resistant, posing a risk of poisoning if the contents are swallowed by young children.
2020-03-18CPSCBelle Chemical, of Billings, Mont.
Belle Chemical Recalls Drain Cleaner Product Due to Violation of FHSA Labeling Requirement
The product contains sodium hydroxide. The label on the product violates the Federal Hazardous Substance Act (FHSA) by omitting the word "poison" for poisonous chemicals and the mandatory hazard statement on the front on the packaging.
2020-03-18CPSCBelle Chemical, of Billings, Mont.
Belle Chemical Recalls Sodium Hydroxide and Potassium Hydroxide Products Due to Failure to Meet Child-Resistant Packaging Requirement and Violation of FHSA Labeling Requirement
The products contain sodium hydroxide or potassium hydroxide which must be in child resistant packaging as required by the Poison Prevention Packaging Act (PPPA). The packaging of the products is not child resistant, posing a risk of chemical burns and irritation to the skin and eyes. In addition, the label on the product violates the Federal Hazardous Substance Act (FHSA) by omitting the word "poison" for poisonous chemicals and the mandatory hazard statement on the front on the packaging.
2020-03-18CPSCThe Boyer Corporation Inc., LaGrange, Ill.
Boyer Recalls Six Brands of Sodium and Potassium Hydroxide Due to Failure to Meet Child-Resistant Packaging Requirement; Injuries Reported
The products contain sodium and/or potassium hydroxide which must be in child resistant packaging as required by the Poison Prevention Packaging Act (PPPA). The packaging of the products is not child resistant, posing a risk of chemical burns and irritation to the skin and eyes.
2020-03-18CPSCNovartis Pharmaceuticals Corporation, of East Hanover, N.J.
Novartis Recalls 100 mg Sandimmune and Neoral Prescription Drug Blister Packages Due to Failure to Meet Child-Resistant Packaging Requirement; Risk of Poisoning
The prescription drug packaging is not child resistant as required by the Poison Prevention Packaging Act (PPPA), posing a risk of poisoning if the contents are swallowed by young children.
2020-03-12CPSCHomestar North America, of Dallas, Texas
Homestar Recalls Dressers Due to Tip-Over and Entrapment Hazards (Recall Alert)
The recalled dressers are unstable if they are not anchored to the wall, posing serious tip-over and entrapment hazards that can result in death or injuries to children.
2020-03-11FDA-DeviceAdvanced Bionics, LLCClass III
SoundWave Professional Suite Software 3.2, Ref CI-6055-014, SPN 058-023-32085, UDI: (01)07630016853227, Logical SoundWave Professional Suite 3.2, CE 0123 - Product Usage: Soundwave 3.2 is used by healthcare professionals to program Advanced Bionics sound processors for use with Advanced Bionics cochlear implants, a device is intended to restore a level of auditory sensation to children with profound sensorineural deafness via electrical stimulation of the auditory nerve.
The manufacturer received complaints that customers were attempting to install the fitting software using the supplied USB drive, an error message was received, and installation failed. The failed installation has not impact to the current version of the software, and users are able to continue programming devices with the current software version.
2020-03-11FDA-DeviceOrgan Recovery Systems, Inc.Class II
LKT200 Perfusion Circuit, part of Lifeport Kidney Perfusion Transporter KTR - Product Usage: The circuit is an accessory to LifePort Kidney Perfusion Transporter (KTR) Isolated kidney perfusion and transport system, which is intended to be used for the continuous hypothermic machine perfusion of kidneys for the preservation, transportation and eventual transplantation into a recipient.
Observed leakage at the sample port assembly which could potentially lead to loss of perfusion solution needed to maintain continuous machine perfusion.
2020-03-11FDA-DeviceSecaClass II
Seca 402/403 Baby Scale Cart, Ref # 4020000009/ REF # 4030000009
It has been determined that the wheels on the baby scale cart can unexpectedly loosen and in the worst case, detach from the cart completely. If this occurs the cart can become unstable and tip over, potentially leading to the scale falling from the cart. If a baby is left unattended in a cart, the baby could fall off the scale and be subjected to several serious injuries.
2020-03-05CPSCJoules USA Inc., of New York
Joules USA Recalls Children's Pajamas and Robes Due to Violation of Federal Flammability Standard; Burn Hazard
The children's garments fail to meet the federal flammability standard for children's sleepwear, posing a risk of burn injuries to children.
2020-03-04CPSCIKEA Supply AG, of Switzerland
IKEA Recalls KULLEN 3-Drawer Chests Due to Tip-Over and Entrapment Hazards; Consumers Urged to Anchor Chests or Return for Refund
The recalled chest is unstable if it is not anchored to the wall, posing tip-over and entrapment hazards that may result in death or serious injuries to children. Additionally, KULLEN 3-drawer chests imported after August 12, 2019 do not comply with the performance requirements of the updated version of the U.S. consensus standard (ASTM 2057-19).
2020-02-27CPSCIshtex Textile Products Inc., of Duluth, Ga.
Just Blanks Children's Nightgowns Recalled by Ishtex Textile Products Due to Violation of Federal Flammability Standard; Burn Hazard
The nightgowns fail to meet the federal flammability standard for children's sleepwear, posing a risk of burn injuries to children.
2020-02-27CPSCThe Step2 Company LLC, of Streetsboro, Ohio
Step2 Recalls Children's Grocery Shopping Carts Due to Laceration Hazard
The shopping cart's basket can break into sharp pieces, posing a laceration hazard.

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