Baby and kids' product recalls
6673 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.
- 2021-12-08CPSCMark of Fifth Avenue, of Harriman, N.Y.Mark of Fifth Avenue Children's Robes Recalled Due to Violation of Federal Flammability Standard and Burn Hazard
The children's robes fail to meet the federal flammability standards for children's sleepwear, posing a risk of burn injuries to children.
- 2021-12-01FDA-FoodMARY RUTH ORGANICSClass IMaryRuth's Organic Infants Liquid Probiotic; Unflavored, a Dietary Supplement. 1 fl. oz. (30 mL) UPC: 8 56645 00858 7 Serving size (five drops - start with one and work up to 5) Organic Proprietary Probiotic Blend 250 mg. Bifidobacterium lactis Bifidobacterium infantis Bifidobacterium bifidum Lactobacillus reuteri Other ingredients: A blend of probiotics in an enzyme enriched substrate, extracted with water from a proprietary blend of three organic grasses.
Internal testing found the presence of Pseudomonas aeruginosa in the product.
- 2021-12-01CPSCHALO Branded Solutions Inc., of Sterling, IllinoisHalo Recalls Promotional Children's Projector Flashlights Due to Button Battery Ingestion and Choking Hazards
A child can disassemble the projector flashlight and access the button cell batteries, posing ingestion and choking hazards.
- 2021-12-01NHTSA-EquipmentClek, Inc.Clek, Inc. — Child Seat Canopy Support May Pose Choking Hazard
A detached piece of plastic can present a choking hazard to a child, increasing the risk of injury.
- 2021-12-01NHTSA-EquipmentClek, Inc.Clek, Inc. — Loose Foam in Child Seat May Become Choking Hazard
Loose pieces of foam can present a choking hazard to a child, increasing the risk of injury.
- 2021-11-17FDA-DrugSUN PHARMACEUTICAL INDUSTRIES INCClass IITadalafil Tablets, USP 20 mg, 30 count bottle, Rx Only, Manufactured for: Northstar Rx LLC Memphis, TN 38141, Manufactured by: Sun Pharmaceutical Industries Limited, India, NDC # 16714-077-01
Incorrect Product Formulation: An incorrect grade of Crospovidone was used to manufacture the product.
- 2021-11-17FDA-DrugSUN PHARMACEUTICAL INDUSTRIES INCClass IITadalafil Tablets, USP 5 mg, 30 count bottle, Rx Only, Manufactured for: Northstar Rx LLC Memphis, TN 38141, Manufactured by: Sun Pharmaceutical Industries Limited, India, NDC # 16714-075-01
Incorrect Product Formulation: An incorrect grade of Crospovidone was used to manufacture the product.
- 2021-11-17FDA-DrugVita Pharmacy, LLC dba Talon Compounding PharmacyClass IIMIC B COMPLEX INJ-MILES FORMULATION INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247
Lack of assurance of sterility
- 2021-11-12CPSCHanna Anderson LLC, of Portland, OregonHanna Andersson Recalls Baby Ruffle Rompers Due to Choking Hazard (Recall Alert)
The snaps on the romper can detach, posing a choking hazard to young children
- 2021-11-12CPSCHanna Anderson LLC, of Portland, OregonHanna Andersson Recalls Baby Long Sleeve Wiggle Sets Due to Choking Hazard (Recall Alert)
The snaps on the long sleeve top can detach, posing a choking hazard to young children.
- 2021-11-12CPSCVidaXL LLC, of Rialto, Calif.VidaXL Recalls Ladders for Above-Ground Pools Due to Fall and Drowning Hazards (Recall Alert)
The steps of the ladder can loosen during use, posing fall and drowning hazards to the user.
- 2021-11-10FDA-DeviceFujiFilm Healthcare Americas CorporationClass IIArietta 65 Ultrasound Software Versions: V1.0 through V4.0.0
When the ultrasound system is used in combination with a Fujifilm (formally Hitachi) transducer, there is an error in the calculation formula of Effective Regurgitant Orifice Area (EROA) when you perform MR Flow combined with Left Ventricular Outflow Tract Flow (LVOT Flow) after performing an echocardiogram. The incorrect value is displayed. In addition, the error appears in the instruction manual
- 2021-11-10FDA-FoodNSE Products, Inc.Class IIPharmanex Kids Jungamals, Dietary Supplement 90 Chewable Tablets, white bottle, NSE Products Inc., Provo, UT 84601 1-888-PHARMANEX
Pharmanex Jungamals was found to have a missing fish allergen statement on the label due to fish gelatin as a sub-component of the Vitamin E ingredient.
- 2021-11-10FDA-FoodKansas City LLC., DBA Best Harvest BakeriesClass IIHotdog buns, customer specified formula, in unlabeled clear plastic bags, 30 or 12 buns per bag.
Positive environmental samples analyzed for Listeria and Salmonella species.
- 2021-11-10FDA-FoodKansas City LLC., DBA Best Harvest BakeriesClass IIHamburger buns, customer specified formula, in unlabeled clear plastic bags, 30 or 12 buns per bag.
Positive environmental samples analyzed for Listeria and Salmonella species.
- 2021-11-10CPSCABUS Mobile Security Inc., of Chicago, IllinoisABUS Recalls Youth Helmets Due to Risk of Head Injury
The recalled helmets do not comply with the U.S. CPSC federal safety standard for bicycle helmets, posing a risk of head injury.
- 2021-11-10USDAClass IThrow out Citterio salame sticks
Product Contamination
- 2021-11-04CPSCBackyard Play Systems LLC, of Monroe, MichiganBackyard Play Systems Recalls Playsets with Wooden Roof Due to Entrapment Hazard (Recall Alert)
The wooden parts used to reinforce and create a decorative gable design on the wooden roof pose an entrapment hazard to children. Children can become trapped in the gap between the lower part of the roof structure and the bottom of the gable decoration.
- 2021-11-03FDA-DrugUltra Seal CorporationClass IIIAdvance Formula Pain Reliever (Acetaminophen 250 mg/Aspirin 250 mg/Caffeine 65 mg) tablets, 2 tablets Per Packet, Packaged in 12,000 Packets/Case, PO# 007564-00, Item# 1170, Mfg. for: Advanced First Aid, Baltimore, MD 21237; American Safety & First Aid, Osceola, IN 46561 (Shipping Label)
Failed Stability Specifications: Out-of-Specification results observed for Aspirin related compound Salicylic Acid.
- 2021-11-03FDA-DrugUltra Seal CorporationClass IIIZEE+ painaid ESF Extra-Strength Formula (Acetaminophen 250 mg, Aspirin 250 mg (NSAID), Caffeine 65 mg) tablets, 2 Tablets per/package, Packaged in a) 50-count packages/carton, b) 125-count packages/carton, PA-ESF 1414Z, Dist. by: Zee Medical Distributors, LLC Mason, OH 45040 (Shipping Label)
Failed Stability Specifications: Out-of-Specification results observed for Aspirin related compound Salicylic Acid.
- 2021-10-29USDAPublic Health AlertDo not eat Citterio salame sticks
Product Contamination
- 2021-10-28CPSCDesign Within Reach Inc., of Stamford, Conn.Design Within Reach Recalls Arc Collection Furniture Due to Violation of the Federal Lead Paint Ban (Recall Alert)
Surface paint on the furniture contain levels of lead that exceed the federal lead paint ban, posing a risk of lead poisoning. Lead is toxic if ingested by young children and can cause adverse health effects.
- 2021-10-27FDA-FoodMaple Island Inc .Class IIParent's Choice Rice Baby Cereal. Stage 1, 4+ months. Fully Cooked. Just add Liquid. Net Wt 8 oz (227g) UPC 81131-08290. Distributed By: Walmart Inc., Bentonville, AR 72716.
Product contains elevated level of inorganic arsenic.
- 2021-10-27FDA-DrugBeiersdorf IncClass IICoppertone Pure & Simple baby 50 Sunscreen Spray (To Deliver) Zinc Oxide 24.08%, NET WT 5 OZ (142 g) can, Beiersdorf Inc., Wilton, CT 06897 UPC 0 72140 02881 7
cGMP Deviations
- 2021-10-27FDA-DrugBeiersdorf IncClass IICoppertone Pure & Simple kids 50 Sunscreen Spray (To Deliver) Zinc Oxide 24.08%, NET WT 5 OZ (142 g) can, Beiersdorf Inc., Wilton, CT 06897 UPC 0 72140 02882 4
cGMP Deviations
- 2021-10-27FDA-DrugBeiersdorf IncClass ICoppertone Pure & Simple baby 50 Sunscreen Spray (To Deliver) Zinc Oxide 24.08%, NET WT 5 OZ (142 g) can, Beiersdorf Inc., Wilton, CT 06897 UPC 0 72140 02881 7
Chemical contamination; presence of benzene
- 2021-10-27FDA-DrugBeiersdorf IncClass ICoppertone Pure & Simple kids 50 Sunscreen Spray (To Deliver) Zinc Oxide 24.08%, NET WT 5 OZ (142 g) can, Beiersdorf Inc., Wilton, CT 06897 UPC 0 72140 02882 4
Chemical contamination; presence of benzene
- 2021-10-27CPSCMagnussen Home Furnishings, Inc., of Riverside, Calif.Magnussen Home Recalls Nova Series 5-Drawer Chests Due to Tip-Over and Entrapment Hazards
The recalled chests are unstable if they are not anchored to the wall, posing tip-over and entrapment hazards that can result in death or serious injuries to children. The chests do not comply with the performance requirements of the voluntary industry standard ASTM F2057-19.
- 2021-10-20FDA-DeviceDraeger Medical, Inc.Class IIBabylog VN500 Ventilator with Installed CO2 Measurement Option-intended for the ventilation of neonatal patients from 0.4 kg (0.88 lbs) up to 10 kg (22 lbs) and pediatric patients from 5 kg (11 lbs) up to 20 kg (44 lbs) bodyweight. Catalog Number: 8417400
Software 2.51 and Lower with Installed CO2 Measurement Option, may result in Restart of the Ventilator, brief cessation of ventilation can occur and loss of PEEP for approx. 8 seconds
- 2021-10-13FDA-DeviceContamac Solutions, Inc.Class IINutrifill Scleral, Hybrid, and Gas Permeable (GP) Lens Insertion Solution, Physiologic Formula, Preservative Free, 35 Single-use 10ml ampoules (360ml), UDI:00850012123002
Contact lens solution may contain foreign material
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