These recalls involve products that pose serious risks of injury or death. Check if you own any of these products and take immediate action if needed.

High Risk Recalls

2,251 critical product recalls that require immediate attention. These products have been identified as posing serious safety hazards.

What to do if you own a recalled product:

  1. Stop using the product immediately
  2. Keep the product away from children
  3. Follow the remedy instructions provided
  4. Contact the manufacturer for a refund or replacement
HIGHFDA FOOD

H-E-B Coconut Yogurt Recalled for Undeclared Almonds

H-E-B recalled 175 cases of Higher Harvest Dairy Free Coconut Based Yogurt on December 17, 2025. The product contains undeclared almonds, posing a serious allergy risk. Consumers should stop using the yogurt immediately and contact the company for refunds.

Plant Based Innovations
Contains undeclared
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HIGHFDA FOOD

Prima Foods Recalls BarbaCuban Sauce Due to Undeclared Quinine

Prima Foods International recalled 12,214 bottles of BarbaCuban 455 Everything Sauce on December 17, 2025. The recall follows the discovery of undeclared quinine, which can pose health risks. Consumers should not consume the sauce and contact the company for refunds.

Prima Foods International
Undeclared Quinine
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HIGHFDA FOOD

Prima Foods Recalls Ketchup Over Undeclared Quinine Hazard

Prima Foods International recalled 12,214 bottles of BarbaCuban Ram Air Red Zesty Ketchup on December 17, 2025. The product contains undeclared quinine, a chemical that can pose health risks. Consumers should not consume this product and should seek refunds or replacements.

Prima Foods International
Undeclared Quinine
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HIGHFDA FOOD

Prima Foods Recalls BarbaCuban 455 Sauce Over Undeclared Quinine

Prima Foods International recalled 12,214 bottles of BarbaCuban 455 Everything Sauce on December 17, 2025. The sauce contains undeclared quinine, posing a health risk to consumers. Affected products were distributed in Florida with best by dates from January to June 2026.

Prima Foods International
Undeclared Quinine
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HIGHFDA FOOD

BarbaCuban White Truffle Sauce Recalled for Undeclared Quinine

BarbaCuban recalled 12,214 bottles of White Truffle Sauce on December 17, 2025, due to undeclared quinine. The affected product poses a high risk to consumers. Customers should not consume the sauce and seek refunds immediately.

Prima Foods International
Undeclared Quinine
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HIGHFDA FOOD

Prima Foods Recalls BarbaCuban Havana Gold Over Quinine Hazard

Prima Foods International recalled 12,214 bottles of BarbaCuban Havana Gold due to undeclared quinine. The recall affects products distributed in Florida. Consumers should not consume the product and seek refunds immediately.

Prima Foods International
Undeclared Quinine
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HIGHFDA DEVICE

Medline Recalls Medical Kits Over High Burn Risk

Medline Industries recalled 1,457 medical procedure convenience kits on December 16, 2025. The kits contain Stryker's Strykeflow 2 Suction Irrigators that may leak and emit vaporized saline. Healthcare providers and patients must stop using the devices immediately.

Medline Industries, LP
Medline kits
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HIGHFDA DEVICE

Medline Recalls Medical Kits Due to Suction Irrigator Leak Hazard

Medline Industries recalled 96 medical procedure convenience kits on December 16, 2025. The recall affects kits containing Stryker's Strykeflow 2 Suction Irrigators due to a design flaw causing leaks. Patients and healthcare providers must stop using these kits immediately.

Medline Industries, LP
Medline kits
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HIGHFDA DEVICE

Medline Medical Kits Recalled Over Strykeflow 2 Suction Hazard

Medline recalled 4,536 medical procedure kits on December 16, 2025. The kits contain Stryker's Strykeflow 2 Suction Irrigators that may leak and emit vaporized saline. The recall affects various models used in surgeries nationwide.

Medline Industries, LP
Medline kits
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HIGHFDA DRUG

SpecGx Recalls Oxycodone and Acetaminophen Tablets Over Missing Imprint

SpecGx LLC recalled 74,544 bottles of Oxycodone and Acetaminophen Tablets on December 16, 2025. The tablets may lack an imprint, raising serious identification issues. Consumers should stop using these medications immediately and contact their healthcare providers for guidance.

OXYCODONE AND ACETAMINOPHEN
Failed Tablet/Capsule
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HIGHFDA DRUG

Alembic Pharmaceuticals Recalls Fesoterodine Tablets for Impurity Risk

Alembic Pharmaceuticals Limited recalled Fesoterodine Fumarate, Extended-release Tablets after discovering high levels of a harmful impurity. The recall affects approximately 30,000 tablets distributed nationwide. Consumers must stop using the medication immediately and consult their healthcare providers.

FESOTERODINE FUMARATE
Failed Impurities/Degradation
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HIGHFDA DEVICE

Medline Medical Kits Recalled Due to Suction Irrigator Hazards

Medline recalled 41,432 medical procedure convenience kits on December 16, 2025. The kits contain Stryker's Strykeflow 2 Suction Irrigators that may leak or emit vaporized saline. This defect poses a high risk of injury during medical procedures.

Medline Industries, LP
Medline kits
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HIGHFDA DEVICE

Medline Recalls Urology Kits Over Leak and Vapor Risks

Medline recalled 12 medical procedure kits on December 16, 2025, due to leaking issues. The kits contain Stryker's Strykeflow 2 Suction Irrigators, which can emit vaporized saline resembling smoke. Patients and healthcare providers must stop using these devices immediately.

Medline Industries, LP
Medline kits
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HIGHFDA DEVICE

Vortex Surgical Recalls Laser Probes Due to Infection Risk

Vortex Surgical recalled 14,789 laser probes on December 16, 2025, due to potential bioburden contamination. The recall affects multiple catalog numbers distributed worldwide. Healthcare providers and patients must stop using these devices immediately.

Vortex Surgical
There may
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HIGHFDA DEVICE

Medline Recalls Medical Procedure Kits Due to Leakage Risk

Medline Industries recalled 12,584 medical procedure convenience kits on December 16, 2025. The recall stems from design changes in Stryker's Strykeflow 2 Suction Irrigators that can lead to leaks or vaporized saline emissions. Healthcare providers and patients must stop using the devices immediately and follow the recall instructions.

Medline Industries, LP
Medline kits
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HIGHFDA FOOD

Qunol Turmeric Capsules Recalled Due to Mold Contamination

Qunol recalled Extra Strength Turmeric Capsules due to mold contamination in raw materials. The recall affects over 3,000 units distributed across 27 states. Consumers should stop use and seek refunds immediately.

QUTEN RESEARCH INSTITIUTE
Mold contamination
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HIGHFDA 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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