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.
- 2019-07-03CPSCM&A Imports Ltd., dba Just Love Fashion, of New York, N.Y.Just Love Fashion Recalls Children's Pajama Pants Due to Violation of Federal Flammability Standard (Recall Alert)
The children's pajama pants fail to meet the flammability standard for children's sleepwear, posing a risk of burn injuries to children.
- 2019-07-03CPSCNature's Truth LLC, of Ronkonkoma, N.Y.Nature's Truth Recalls Wintergreen Essential Oil Due to Failure to Meet Child Resistant Closure Requirements
The bottles are not child resistant as required by the Poison Prevention Packaging Act, posing a poisoning risk if the contents are swallowed by young children.
- 2019-06-27CPSCFisher-Price, of East Aurora, N.Y.Fisher-Price Recalls Inclined Sleeper Accessory Included with Ultra-Lite Day & Night Play Yards Due to Safety Concerns About Inclined Sleep Products
Infant fatalities have been reported while using other inclined sleep products, after the infants rolled from their back to their stomach or side while unrestrained, or under other circumstances.
- 2019-06-26FDA-DeviceGE Healthcare, LLCClass IILVivo EF app on Vscan Extend. Sold under the following product names: a. Vscan Extend Dual DICOM, Model Numbers H41212ZA, H41212RN; b .Vscan Extend Dual USB, Model Number H41212RK; c. Vscan Extend Dual Wi-Fi, Model Numbers H41212YZ, H41212RL; d. Vscan Extend Sector DICOM, Model Number H41212ZD; e. Vscan Extend Sector USB, Model Number H41212RR; f. Vscan Extend Sector Wi-Fi, Model Number H41212ZC Product Usage: Vscan Extend is a general- purpose diagnostic ultra
Overestimation bias in automatically calculated ejection fraction (EF) values while using LVivo EF app on the Vscan Extend product.
- 2019-06-26FDA-FoodBobbie Baby incClass IBobbie Milk-Based Powder Companion Formula Net Wt. 14.1 oz. (400g) 22 servings per container Serving Size 4 scoops. Made in Germany Distributed by Bobbie Baby 520 Divisadero ST # 111 San Francisco, CA 94117
The product does not provide adequate nutrition for some infants.
- 2019-06-26FDA-DrugP & L Developments, LLCClass IICetirizine Oral Solution 1 mg/mL, Up & Up, Children's allergy relief, Antihistamine, Dye Free, Grape Flavor, 4 FL. oz. (118 mL) Bottle, Distributed by Target Corporation, Minneapolis, MN 55403, NDC 11673-178-04, UPC 359726178044.
cGMP Deviations: Firm was notified by their supplier of Cetirizine HCL Oral Solution, USP, 1mg/mL, 4oz, of the voluntary recall that they have initiated due to potential contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
- 2019-06-26FDA-DrugP & L Developments, LLCClass IICetirizine Oral Solution 1 mg/mL, Children's Allergy, Antihistamine, Dye Free, Grape Flavor, 4 FL. oz. Bottle, Distributed by C.D.M.A. Inc., Novi, MI 48376, Quality Choice, NDC 63868-430-04, UPC 635515992474.
cGMP Deviations: Firm was notified by their supplier of Cetirizine HCL Oral Solution, USP, 1mg/mL, 4oz, of the voluntary recall that they have initiated due to potential contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
- 2019-06-26FDA-DrugP & L Developments, LLCClass IICetirizine HCL Oral Solution 1 mg/mL, Children's Allergy, Antihistamine, Dye Free, Gluten Free, Grape Flavor, 5 mg/5mL, 4 FL. oz. Bottle, Distributed by Dolgencorp, LLC, 100 mission ridge, Goodlettsville, TN 37072, NDC 55910-878-04, UPC 359726178051.
cGMP Deviations: Firm was notified by their supplier of Cetirizine HCL Oral Solution, USP, 1mg/mL, 4oz, of the voluntary recall that they have initiated due to potential contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
- 2019-06-19FDA-FoodWismettac Asian Foods, INCClass IICHOCOLATE CHOCO BABY (S) MEIJI, 1.19 oz. Item number 70582 UPC 074410705824 - only on those bars with English labeling. Distributed by Wismettac Asian Foods, Inc.
Some chocolate products imported from Japan do not have the English label for Nutrition facts, ingredients or allergens, which include milk, soy, egg, tree nuts.
- 2019-06-19FDA-DrugNovis PR, Inc.Class IPecgen DMX Cough Suppressant Expectorant, Contains the same active ingredients as Trispec DMX, Sugar Free, Alcohol Free, Dye Free, Gluten Free, Cherry Raspberry Flavor, 16 Fl. oz. (474 mL), Manufactured in the USA for Kramer Novis, San Juan, PR 00917, www.kramernovis.com, NDC 52083-630-16.
Labeling: Incorrect Instructions; The product has been found to provide incorrect dosage information on its label due to a typographical error. The drug facts label incorrectly states children 6 to under 2 years of age, 1 teaspoonful every 4 hours, not to exceed 4 teaspoonfuls in 24 hours or directed by physician. The label should state children 6 to under 12, 1 teaspoonful every 4 hours, not to exceed 4 teaspoonfuls in 24 hours or as directed by physician. Additionally, the label does not advise consumers to consult a doctor for children under 2 years of age.
- 2019-06-19FDA-DrugTorrent Pharma IncClass IIKid Kare Childrens Cough/Cold Liquid, Antihistamine, Cough Suppressant, Nasal Decongestant, Cherry Flavored, Alcohol Free, (Chlorpheniramine Maleate, USP 2 mg, Dextromethorphan HBr, USP 10 mg, Pseudoephedrine HCl, USP 30 mg in each 2 tsp (10mL)), 4 Fl. oz. bottle, NDC: 0536-2310-97, Distributed by Rugby Laboratories, Livonia MI 48152.
cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
- 2019-06-19FDA-DrugTorrent Pharma IncClass IIRobafen Cough Formula Expectorant (guaifenesin USP 200 mg in each 10 mL), a) 4 Fl. oz. (118 mL) bottle, NDC: 0904-0061-00, b) One Pint ( 473 mL) bottle, NDC: 0904-0061-16, Distributed by Major Pharmaceuticals, Livonia MI 48152.
cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
- 2019-06-19FDA-DrugTorrent Pharma IncClass IIChildren's Mapap Acetaminophen Liquid, Fever reducer, Pain reliever, Alcohol free, Aspirin free, Cherry flavored, acetaminophen 160 mg per 5 mL, a) 4 FL. oz. (118 mL) bottle, NDC 0904-1985-20, b) One Pint (473 mL) bottle, NDC: 0904-1985-16, Distributed by Major Pharmaceuticals, Livonia MI 48152.
cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
- 2019-06-19FDA-DrugTorrent Pharma IncClass IIChildren's Acetaminophen Liquid, 160 mg per 5 mL, Fever and Pain, Alcohol free, aspirin free, ibuprofen free, Cherry Flavor, 4 FL. oz. (118 mL) bottle, NDC: 59741-101-06, Manufactured by Bio-Pharm, Inc., Levittown PA 19057, Assured.
cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
- 2019-06-18CPSCHome Meridian International, of High Point, N.C.Home Meridian Recalls Corner Curio Cabinets Due to Tip-Over and Entrapment Hazards; Sold Exclusively at Havertys (Recall Alert)
The recalled curio cabinets 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.
- 2019-06-11CPSCCJCHT Groups LTD., of Hong KongTarget Recalls Toddler Boots Due to Choking Hazard
The unicorn horn on the rain boot can detach, posing a choking hazard to young children.
- 2019-06-05FDA-DeviceMaquet Cardiovascular, LLCClass IIMaquet Getinge- BEQ-T 9411 Lurie Children's 1/4 ADAPT Material:709000485R01
Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of humidity/ethylene oxide gas into the fluid-path between the closed port and the non-vented cap therefore the Sterility Assurance Level (SAL) of the stopcock ports cannot be assured
- 2019-06-05FDA-DeviceMaquet Cardiovascular, LLCClass IIMaquet Getinge-BEQ-TOP 49101 Childrens Large ECC Pack Material: 701067069R01
Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of humidity/ethylene oxide gas into the fluid-path between the closed port and the non-vented cap therefore the Sterility Assurance Level (SAL) of the stopcock ports cannot be assured
- 2019-06-05FDA-DeviceMaquet Cardiovascular, LLCClass IIMaquet Getinge- BEQ-T 5211 ECC Large Children's Hospital Material: 701064560R01
Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of humidity/ethylene oxide gas into the fluid-path between the closed port and the non-vented cap therefore the Sterility Assurance Level (SAL) of the stopcock ports cannot be assured
- 2019-06-05FDA-DeviceMaquet Cardiovascular, LLCClass IIMaquet Getinge- BEQ-TOP 28901 MCV INFANT ECC Material:701056771R01
Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of humidity/ethylene oxide gas into the fluid-path between the closed port and the non-vented cap therefore the Sterility Assurance Level (SAL) of the stopcock ports cannot be assured
- 2019-06-05FDA-DeviceMaquet Cardiovascular, LLCClass IIMaquet Getinge-BEQ-TOP 38302 INFANT CPS QPID Material: 701055866
Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of humidity/ethylene oxide gas into the fluid-path between the closed port and the non-vented cap therefore the Sterility Assurance Level (SAL) of the stopcock ports cannot be assured
- 2019-06-05FDA-DeviceMaquet Cardiovascular, LLCClass IIMaquet Getinge-BEQ-TOP 21502# Med City Childr Material: 701050060
Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of humidity/ethylene oxide gas into the fluid-path between the closed port and the non-vented cap therefore the Sterility Assurance Level (SAL) of the stopcock ports cannot be assured
- 2019-06-05FDA-DrugInopak LtdClass IIAQUACIL instant foaming hand sanitizer, alcohol free formula, benzalkonium chloride 0.1% (w/w), packaged in a) 18 FL OZ (532 mL) bottles, 12/18OZ bottles per case, Product Code BIO-5075-432-02; b) 1000 ML pouches, 6/1000 ML pouches per case, Product Code BIO575-OS1000, Biocentris Pharmaceuticals (Division of Inopak).
CGMP Deviations: hand sanitizers and soaps were not produced under current good manufacturing practices.
- 2019-05-29FDA-DrugSeptodont Inc.Class IIArticaine DENTAL, Articane hydrochloride 4% and epinephrine 1:100,000, 50 cartridges. 1.7 mL each, Rx only, Manufactured for: DENTSPLY Pharmaceutical, by Novocol Pharmaceutical of Canada, Inc. York, PA 17404, NDC 66312-601-16 Reorder #: 51116
Labeling: Not Elsewhere Classified. This recall has been initiated due to mislabeling. The printed carton used in manufacturing both batches contained text for both 2% Xylocaine DENTAL and Articadent DENTAL. Xylocaine DENTAL is a trade name for Lidocaine HCL 2% and Epinephrine 1: 100,000 formulation, while Articadent DENTAL is a trade name for Articaine HCI 4% and Epinephrine 1 :100,000. The cartridges contained within the printed carton are labeled appropriately as Articadent DENTAL.
- 2019-05-29CPSCAegean Apparel, Inc. of Dayton, OhioAegean Apparel Recalls Children's Sleepwear Due to Violation of Federal Flammability Standard
The children's sleepwear garments fail to meet the flammability standard for children's sleepwear, posing a risk of burn injuries to children.
- 2019-05-28CPSCGildan Activewear SRL, of BarbadosChildren's Sleep Sacks Recalled by Gildan Activewear Due to Violation of Federal Flammability Standard; Sold Exclusively at AmericanApparel.com (Recall Alert)
The children's sleep sacks fail to meet the flammability standard for children's sleepwear, posing a risk of burn injuries to children.
- 2019-05-22FDA-DrugUnipharma, Llc.Class IICVS Health Children's Cough & Chest Congestion DM Dextromethorphan HBr, 5 mg Cough Suppressant Guaifenesin, USP 100 mg Expectorant Mixed Berry Flavor 20 Single-Use Vials 0.17 fl. oz. (5 mL), Distributed by: CVS Pharmacy, Inc. One CVS Drive, Woonsocket, RI 02895,NDC 69842-262-01, UPC 050428598368
CGMP Deviations: Recall as a precautionary measure due to potential risk of product contamination with the bacteria B. cepacia.
- 2019-05-22FDA-DrugUnipharma, Llc.Class IIDrKids Himasal Natural Nasal Saline Solution with Himalayan Salt, 20 count Single-Use Vials, Drug Free, Manufactured by: Unipharma, LLC. Tamarac, FL 33321, a) 0.02 fl. oz. (0.5 mL), UPC 370302446081; b) 0.05 fl. oz. (1.5 mL), UPC 370302446098
CGMP Deviations: Recall as a precautionary measure due to potential risk of product contamination with the bacteria B. cepacia.
- 2019-05-22FDA-DrugUnipharma, Llc.Class IICVS Health Children's Nasal Saline Drops With Himalayan Salt Saline Nasal Moisturizer Single-Use 30 Single-Use 0.05 fl. oz. (1.5 mL), Distributed by: CVS Pharmacy, Inc. One CVS Drive Woonsocket, RI 02895, UPC 050428598207
CGMP Deviations: Recall as a precautionary measure due to potential risk of product contamination with the bacteria B. cepacia.
- 2019-05-22FDA-DrugUnipharma, Llc.Class IIDrKids Children's Natural Cough Syrup English Ivy Leaf Organic Agave Nectar Pre-measured Single-Use 0.17 fl. oz. (5 mL), Manufactured in USA by: Unipharma, LLC. Tamarac, FL 33321, UPC 370302489019
CGMP Deviations: Recall as a precautionary measure due to potential risk of product contamination with the bacteria B. cepacia.
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