Drug Recalls Center

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

514
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

BioPro Recalls Endo Heads Due to Sterility Risk

BioPro recalled 147 units of Endo Heads on September 9, 2025. A packaging issue may compromise the sterile barrier, leading to infection risk. Healthcare providers and patients should stop using the devices immediately.

BioPro
Potential packaging
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HIGHFDA DEVICE

BioPro Recalls Femoral Heads Over Sterile Barrier Risk

BioPro recalled 147 femoral heads on September 9, 2025, due to a packaging defect. The defect threatens the sterility of the device, which could lead to infection if implanted. Healthcare providers and patients must stop using these devices immediately.

BioPro
Potential packaging
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HIGHFDA DEVICE

Iantrek Recalls C-Rex UNO Goniotomy Instrument Over Sterility Risk

Iantrek recalled 198 C-Rex UNO Microinterventional Goniotomy Instruments on September 6, 2025, due to compromised sterile packaging. The recall affects the model CRX-120 distributed in multiple U.S. states. Healthcare providers and patients must stop using these instruments immediately.

Iantrek
Potential for
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HIGHFDA DEVICE

Iantrek Recalls Cyclopen Microinterventional System Over Sterility Risk

Iantrek recalled 1,262 units of the Cyclopen Microinterventional Cyclodialysis System on September 6, 2025. The recall stems from a risk of compromised sterile packaging that could affect patient safety. Health care providers and patients must stop using the device immediately and follow manufacturer instructions.

Iantrek
Potential for
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HIGHFDA DRUG

Sandoz Recalls Cyclophosphamide Injection Over Safety Concerns

Sandoz Inc. recalled 263 vials of Cyclophosphamide Injection on September 5, 2025. The recall follows cGMP deviations related to temperature excursions during transportation. Healthcare providers and consumers must stop using the product immediately.

Sandoz
cGMP deviations:
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HIGHFDA DRUG

Apotex Recalls Ophthalmic Solution Over Sterility Concerns

Apotex Inc. recalled 151,034 bottles of Brimonidine Tartrate/Timolol Maleate Ophthalmic Solution on September 5, 2025. The recall stems from a lack of assurance of sterility due to improper bottle sealing. Consumers should stop using the product immediately and contact their healthcare provider or Apotex Corp.

BRIMONIDINE TARTRATE/TIMOLOL MALEATE OPHTHALMIC SOLUTION
Lack of
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HIGHFDA DRUG

Apotex Recalls Ketorolac Ophthalmic Solution Over Sterility Concerns

Apotex Corp. recalled 493,468 bottles of Ketorolac Tromethamine Ophthalmic Solution on September 5, 2025. The recall stems from a lack of assurance of sterility due to improper bottle sealing. Consumers should stop using the product immediately and contact their healthcare provider for guidance.

KETOROLAC TROMETHAMINE
Lack of
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HIGHFDA DEVICE

GE Medical Systems Recalls AW Server Models Over Data Security Risk

GE Medical Systems recalled 7,302 AW Server units on September 5, 2025, due to a critical security vulnerability. The flaw could allow unauthorized access to sensitive patient data. Healthcare providers and patients must cease use immediately and follow recall procedures.

GE Medical Systems
Firm has
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HIGHFDA DEVICE

Spacelabs Healthcare Recalls DVI Display Cables Over Safety Risk

Spacelabs Healthcare recalled 16,898 DVI display cables on September 5, 2025. The cables may not comply with electromagnetic interference standards, posing risks to patient safety. Healthcare providers and patients must stop using these cables immediately.

Spacelabs Healthcare
Due to
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HIGHFDA DEVICE

GE Healthcare Recalls Carescape Central Station Due to Reboot Risk

GE Healthcare recalled 173 units of the Carescape Central Station on September 5, 2025. The device may enter a continuous reboot cycle, risking loss of patient monitoring. This issue occurs when 118 to 120 stations connect to the network.

Wipro GE Healthcare Private
GE HealthCare
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HIGHFDA DEVICE

GE Healthcare Recalls Carescape Central Station Over Reboot Risk

GE Healthcare recalled 2,306 Carescape Central Station devices on September 5, 2025, due to a software issue. The problem can cause a continuous reboot cycle, risking loss of patient monitoring. The recall affects devices with software version V3.0.5 when connected in specific network conditions.

Wipro GE Healthcare Private
GE HealthCare
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HIGHFDA DRUG

Zydus Pharmaceuticals Recalls Entecavir Tablets Over Impurity Risk

Zydus Pharmaceuticals recalled 4,440 bottles of Entecavir Tablets on September 4, 2025. The recall follows failure to meet impurity and degradation specifications. Consumers should stop using the affected tablets immediately and contact their healthcare provider.

Zydus Pharmaceuticals USA Inc.
Failed Impurity/Degradation
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HIGHFDA DEVICE

American Contract Systems Recalls Medical Kits Over Sterilization Issues

American Contract Systems recalled 32,433 medical convenience kits on September 4, 2025. The recall follows the identification of products that were re-gassed after sterilization failures. The safety and effectiveness of these products cannot be confirmed due to multiple sterilization cycles.

American Contract Systems
Identified products
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HIGHFDA DEVICE

Lutronic Recalls Electrosurgical Unit Due to Defect Risks

Lutronic recalled 7,490 units of the XERF EFFECTOR 60 electrosurgical unit on September 4, 2025. Manufacturing defects may lead to adverse events for patients. Devices manufactured between April 1, 2025, and August 20, 2025, are affected.

Lutronic
Manufacturing defects
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HIGHFDA DEVICE

American Contract Systems Recalls Radiology Packs Over Sterilization Issues

American Contract Systems recalled 32,433 radiology packs on September 4, 2025, due to improper sterilization. The products were re-gassed after a nonconformance in the initial Ethylene Oxide gas injection process. Their safety and effectiveness remain unverified after multiple sterilization cycles.

American Contract Systems
Identified products
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HIGHFDA DEVICE

American Contract Systems Biopsy Tray Recalled Over Sterilization Issues

American Contract Systems recalled 32,433 Basic Biopsy Trays on September 4, 2025. The recall resulted from products being re-gassed after a sterilization failure. The company cannot confirm the safety or effectiveness of these devices after multiple sterilization cycles.

American Contract Systems
Identified products
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HIGHFDA DEVICE

American Contract Systems Recalls Medical Kits Over Sterilization Issues

American Contract Systems recalled 32,433 medical convenience kits on September 4, 2025. The recall follows issues with multiple sterilization cycles that compromise product safety. Patients and healthcare providers should stop using these devices immediately.

American Contract Systems
Identified products
Read more
HIGHFDA DEVICE

American Contract Systems Recalls Medical Kits Over Safety Risk

American Contract Systems recalled 32,433 medical convenience kits on September 4, 2025. These kits failed to meet safety standards due to improper sterilization processes. The recall affects multiple states, including South Dakota and Iowa.

American Contract Systems
Identified products
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