infant product Recalls

794 recalls tagged with “infant product”.

Health & Personal Care
HIGH
FDA DRUG

Sun Pharmaceutical Fluocinolone Acetonide Topical Solution Recall 24,624 Bottles (2025)

Sun Pharmaceutical Industries is recalling 24,624 bottles of Fluocinolone Acetonide Topical Solution nationwide after out-of-spec impurity D was detected. The product is distributed by Taro Pharmaceuticals in the United States and labeled Rx-only. Consumers must stop using the product and consult a healthcare provider for guidance.

Fluocinolone Acetonide
Failed Impurities/Degradation
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Health & Personal Care
HIGH
FDA DRUG

Gold Star Distribution Recalls Excedrin Migraine 2's 25 CT Over Rodent-Contamination Risk (2026)

Gold Star Distribution recalls Excedrin Migraine 2's, 25-count bottles distributed nationwide in the United States. CGMP deviations involve insanitary conditions including rodent exposure in the distribution center. Consumers and healthcare providers should stop using the product immediately and contact Gold Star Distribution or their healthcare provider for guidance.

Gold Star Distribution
CGMP Deviations:
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Health & Personal Care
HIGH
FDA DRUG

Carmex Lip Balm Recalled by Gold Star Distribution for 12-Count Jars and Tubes (2026)

Gold Star Distribution Inc. is recalling Carmex lip balm in 12-count jars and 12-count tubes distributed nationwide in the United States. The recall cites CGMP deviations and insanitary conditions at the distribution center, including rodent exposure. Consumers and healthcare providers should stop using the product immediately and contact Gold Star Distribution for guidance.

GOLD STAR DISTRIBUTION
CGMP Deviations:
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Health & Personal Care
HIGH
FDA DRUG

GOLD STAR DISTRIBUTION Vaporizing Chest Rub Recall 2026 All Lots Nationwide

Gold Star Distribution is recalling all lots of its Vaporizing Chest Rub, 4 oz, 12-count, UPC 048155903319, distributed nationwide in the United States. The recall, number D-0283-2026, stems from CGMP deviations including insanitary conditions with rodent exposure/activity at the distribution center. Consumers and healthcare providers should stop using the product immediately and contact Gold Star

Gold Star Distribution
CGMP Deviations:
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Health & Personal Care
HIGH
FDA DEVICE

Cardinal Health Chest Drainage Units Recalled Over Infant Hazards

Cardinal Health recalled 1,169,726 chest drainage units on December 26, 2025. The recall stems from an update to the instructions for use (IFU) clarifying that the devices are intended for adults only. Using these devices on infants may result in delayed treatment and prolonged hospitalization.

Cardinal Health 200
The firm
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Health & Personal Care
HIGH
FDA DRUG

Aleve 60-Count Pain Relievers Recalled for CGMP Deviations by Gold Star Distribution (2026)

Gold Star Distribution recalls Aleve 60-count pain relievers distributed nationwide due to CGMP deviations and insanitary conditions at its distribution center. Rodent exposure and activity were reported at the facility. Consumers and healthcare providers should stop using the product immediately and contact Gold Star Distribution for guidance.

Aleve
CGMP Deviations:
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Health & Personal Care
HIGH
FDA DRUG

Tylenol Recall by Gold Star Distribution Affects 5 SKUs in 2026

Gold Star Distribution is recalling Tylenol products distributed nationwide. The recall concerns CGMP deviations and insanitary conditions at the distributor’s facility. Consumers should stop using these Tylenol products immediately and contact Gold Star Distribution for guidance.

Gold Star Distribution
CGMP Deviations:
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Health & Personal Care
HIGH
FDA DEVICE

Altruan GmbH Bisaf Strep A Self-Test Recalled for FDA Clearance Issue

Bisaf Strep A Self-Test from Altruan GmbH remains active in recall status after the FDA flagged lack of clearance. The Class II medical device was distributed nationwide in the United States. The hazard is lack of FDA clearance. Consumers should stop use immediately and follow manufacturer guidance.

Altruan
Product not
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Health & Personal Care
HIGH
FDA DEVICE

Wondfo Streptococcal A At-Home Self-Test Recalled for FDA Clearance Issues (2026)

Wondfo recalled 188 units of Streptococcal A At-Home Self-Test sold nationwide in the United States after regulators found the device was not FDA-cleared. The recall centers on lack of FDA clearance for safety and effectiveness. Consumers should stop using the test immediately and contact Altruan GmbH or their healthcare provider for instructions.

Wondfo
Product not
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Recalled Meaicezli Play Purse Set Packaging
HIGH
CPSC

Meaicezli Play Purse Sets Recalled Over Battery Ingestion Risk

Meaicezli recalled Play Purse Sets on December 18, 2025, due to a risk of serious injury from battery ingestion. The toys contain button cell and lithium coin batteries accessible to children. Consumers must stop using the products and return them for a full refund.

Meaicezli
The children's
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Health & Personal Care
HIGH
FDA DEVICE

Vascutek Gelsoft Plus and Gelweave Vascular Prostheses Recalled for Shelf-Life Label Error (37,430,

Vascutek recalled 37,430 Gelsoft Plus and Gelweave vascular prostheses distributed nationwide in the United States after discovering the devices were labeled with an extra month of shelf life. The expiry date was calculated from packaging rather than gel impregnation. Healthcare providers and patients should stop using the devices immediately and follow recall instructions.

Vascutek
Gelatin sealed
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Recalled 17 Stories Furniture Dresser in black (front)
HIGH
CPSC

17 Stories Furniture 18-Drawer Dressers Recalled Over Tip-Over Hazard

17 Stories Furniture recalled 18-Drawer Dressers on December 18, 2025, due to tip-over and entrapment hazards. The dressers pose a serious risk of injury or death to children if not anchored to the wall. This recall affects models HI1382_13, HI1382_01, and HI1382_09.

Jiangsu Quanronghe Smart Home Co., Ltd., of China
The recalled
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Health & Personal Care
HIGH
FDA DEVICE

Vortex Surgical Polisher Recalled Due to Infection Risk

Vortex Surgical recalled 14,789 Tecfen Retractable Membrane Polishers on December 16, 2025. The recall stems from potential voids in Tyvek pouches that may compromise sterility and lead to bioburden contamination. Healthcare providers and patients must stop using the products immediately.

Vortex Surgical
There may
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Health & Personal Care
HIGH
FDA DEVICE

Vortex Surgical Recalls Internal Delivery Device Over Infection Risk

Vortex Surgical recalled 14,789 units of its 25GA I.D.D. Internal Delivery Device on December 16, 2025. The recall stems from potential voids in the seal of Tyvek pouches that may compromise sterility, leading to infection risks. Healthcare providers and patients are urged to stop using the device immediately and follow recall instructions.

Vortex Surgical
There may
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Food & Beverages
HIGH
FDA FOOD

Prima Vera Nueva Tamales Recalled for Listeria Risk

Prima Vera Nueva recalled 9,656 packages of Roasted Pumpkin & White Cheddar Tamales on December 12, 2025. The recall stems from potential contamination with Listeria monocytogenes. Consumers should not eat these tamales and seek refunds immediately.

Prima Vera Nueva
Potential contamination
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Health & Personal Care
HIGH
FDA DEVICE

Fujirebio Diagnostics Recalled pTau 217 Plasma Cartridges

Fujirebio Diagnostics recalled 1,569 units of Lumipulse G pTau 217 Plasma Immunoreaction Cartridges on December 11, 2025. The recall affects users due to potential inaccurate test results associated with Alzheimer's disease classifications. Customers in 13 states should stop using the product immediately.

Fujirebio Diagnostics
Customers may
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Recalled MY26 Domane+ ALR 5 Electric Bicycle
MEDIUM
CPSC

TREK Recalls 4 Electric Bicycles Over Chainring Bolt Hazard (2026 Domane+ ALR 5, ALR 6 AXS, Checkpoi

TREK recalled four electric bicycles sold through Trek authorized retailers and independent bike shops nationwide and online. The chainring bolts can loosen, causing the chainring to detach and create a fall hazard. Owners should stop riding immediately and contact an authorized Trek dealer for a free repair; Trek provides a $20 in-store credit toward Trek, Electra, or Bontrager merchandise, valid

TREK
The bolts
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Health & Personal Care
HIGH
FDA DEVICE

Fujirebio Diagnostics Recalls Lumipulse pTau 217 Plasma Controls Due to High Risk of Inaccurate Test

Fujirebio Diagnostics recalled 148 units of Lumipulse pTau 217 Plasma Controls on December 11, 2025. The recall follows reports of inaccurate test results that misclassify patients regarding Alzheimer’s disease. The affected product may falsely elevate positive or indeterminate results, increasing the risk of incorrect patient classification.

Fujirebio Diagnostics
Customers may
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Recalled Vevor Ice Crusher, model number BY-300 in yellow (SBY-300FD110V3ZIQV1)
HIGH
CPSC

Sanven Technology Recalls Vevor Ice Crushers for Fire Hazard (2025)

Sanven Technology recalled Vevor ice crushers after a fire hazard was identified in BY-300 and BY-300 FS models. The units, sold as Ice Shavers, Ice Crushers and Snow Cone Makers, can experience a thermal event that could ignite. Stop using the recalled devices immediately and contact Sanven Technology for a full refund.

Sanven Technology
The ice
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Recalled VEVOR Garment Steamer – side view
HIGH
CPSC

Sanven Technology Recalls VEVOR Garment Steamers for Burn Hazard (2025)

Sanven Technology recalled VEVOR Garment Steamers sold online after a burn hazard was identified. Affected units can leak or spit hot water, and the water tank cap can leak or detach. Consumers should stop using the recalled steamers and request a full refund from Sanven Technology.

Sanven Technology
The steamers
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