Drug Recalls Center

1,425 pharmaceutical and medication recalls tracked. Stay informed about FDA drug safety alerts, prescription medications, over-the-counter drugs, and dietary supplements.

1,425
Total Drug Recalls
24
High Risk Medications
FDA
Official Source

Important Medication Safety Information

  • Do not stop taking prescribed medications without consulting your healthcare provider
  • Contact your pharmacist or doctor if you have a recalled medication
  • Check lot numbers carefully - not all batches may be affected
  • Return recalled medications to your pharmacy for proper disposal

Looking for a specific drug? Use the search page to find recalls by medication name, manufacturer, or NDC number.

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 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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HIGHFDA DEVICE

Vortex Surgical Recalls Injection Cannula Due to Infection Risk

Vortex Surgical recalled 14,789 units of its 25GA Subretinal Injection Cannula on December 16, 2025, due to a compromised sterile barrier. The recall affects devices distributed worldwide, including 8,651 units in the U.S. The issue may lead to bioburden contamination and potential infection.

Vortex Surgical
There may
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HIGHFDA DEVICE

Vortex Surgical Recalls Forceps and Cannula Due to Infection Risk

Vortex Surgical recalled 14,789 disposable forceps and cannula on December 16, 2025, due to potential bioburden contamination. The recall affects various models distributed worldwide, including 8,651 in the U.S. and 6,138 internationally. Users should stop using these devices immediately to prevent infection risk.

Vortex Surgical
There may
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HIGHFDA DEVICE

Vortex Surgical Recalls Disposable Elevator Over Infection Risk

Vortex Surgical recalled 14,789 Disposable Diamond Dusted ILM Elevators on December 16, 2025. The recall follows concerns about voids in the seal of Tyvek pouches, which could lead to bioburden contamination. Healthcare providers and patients should stop using the devices immediately.

Vortex Surgical
There may
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HIGHFDA DEVICE

Vortex Surgical IOL Marker Recalled Over Infection Risk

Vortex Surgical recalled 14,789 units of its Lindsell Sutured IOL Marker on December 16, 2025. The recall stems from potential voids in the seal of Tyvek pouches, risking bioburden contamination. Healthcare providers and patients must stop using the device immediately.

Vortex Surgical
There may
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HIGHFDA DEVICE

Vortex Surgical Recalls Vitrectomy Lenses Due to Infection Risk

Vortex Surgical recalled 14,789 single-use vitrectomy lenses on December 16, 2025. The recall affects models with potential seal voids that could lead to bioburden contamination. Patients and healthcare providers must stop using these devices immediately.

Vortex Surgical
There may
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HIGHFDA 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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HIGHFDA DEVICE

Vortex Surgical Recalls Convenience Kits Over Infection Risk

Vortex Surgical recalled 14,789 convenience kits on December 16, 2025, due to potential contamination risks. Voids in the seal of Tyvek pouches may compromise sterile barriers, leading to infection. Patients and healthcare providers should stop using these kits immediately.

Vortex Surgical
There may
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HIGHFDA DEVICE

Vortex Surgical Recalls Illuminated Depressor Due to High Hazard

Vortex Surgical recalled 14,789 units of the TID Pharos Illuminated Depressor on December 16, 2025. The recall affects 8,651 units in the U.S. and 6,138 units internationally. Patients and healthcare providers should cease use immediately due to a high hazard level.

Vortex Surgical
XXX
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HIGHFDA DEVICE

Vortex Surgical Recalls 25GA Backflush Pouches Over Infection Risk

Vortex Surgical recalled 14,789 surgical backflush pouches on December 16, 2025, due to compromised sterile barriers. The recall affects catalog numbers VS0270.25 and VS0275.27, with potential for bioburden contamination. Healthcare providers and patients should stop using these devices immediately.

Vortex Surgical
There may
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HIGHFDA DEVICE

Vortex Surgical Injection Kit Recalled Over Infection Risk

Vortex Surgical recalled 14,789 I2 Injection Kits on December 16, 2025. Voids in the seal of Tyvek pouches may compromise sterility, posing an infection risk. Healthcare providers and patients must stop using this device immediately.

Vortex Surgical
There may
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HIGHFDA DEVICE

Philips Medical System Recall Over Electrical Hazard Risk

Philips Medical Systems Nederland B.V. recalled 22 Allura Xper FD10/10 systems on December 15, 2025. The recall stems from a potential electrical hazard due to an improperly installed drip tray. Patients and healthcare providers must stop using these devices immediately.

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Philips has
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