Drug Recalls Center

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

895
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 DRUG

Mylan Haloperidol Lactate Injection Recalled Over Labeling Errors

Mylan Institutional LLC recalled 800 vials of Haloperidol Lactate Injection on October 10, 2025, due to incorrect RFID tag labels. The product may pose a risk due to potential mislabeling affecting tracking and administration. Healthcare providers should stop using the product immediately and follow up with Safecor Health for guidance.

HALOPERIDOL LACTATE
Labeling: Not
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HIGHFDA DRUG

STAQ Pharma Recalls Ketamine Injection Over Labeling Issues

STAQ Pharma Inc. recalled Ketamine Hydrochloride 50mg/5 mL syringes on October 9, 2025. The recall affects products with incorrect or missing lot and expiration dates. The FDA classified this recall as Class III due to potential risks to patient safety.

STAQ Pharma
Labeling: Incorrect
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HIGHFDA DRUG

STAQ Pharma Recalls Hydromorphone Injection Over Labeling Issues

STAQ Pharma Inc. recalled Hydromorphone HCL PF injections on October 9, 2025, due to incorrect or missing lot and expiration dates. The recall affects products distributed nationwide across the U.S. Healthcare providers and consumers must immediately cease using the affected medication.

STAQ Pharma
Labeling: Incorrect
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HIGHFDA DRUG

STAQ Pharma Recalls FentaNYL Citrate Injection Due to Labeling Issues

STAQ Pharma Inc. recalled FentaNYL Citrate PF on October 9, 2025, due to incorrect or missing lot and expiration dates. The injection, distributed nationwide, poses a high hazard risk. Consumers and healthcare providers should stop using the product immediately.

STAQ Pharma
Labeling: Incorrect
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HIGHFDA DRUG

American Health Packaging Recalls Sucralfate Tablets Over Quality Concerns

American Health Packaging recalled 27,868 blister packs of Sucralfate Tablets on October 9, 2025. The company filed for Chapter 11 bankruptcy, impairing its ability to monitor product quality. Consumers should stop using the product immediately and seek guidance from healthcare providers.

SUCRALFATE
CGMP Deviations:
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HIGHFDA DRUG

USV Private Recalls Olopatadine Eye Drops for Impurity Risk

USV Private recalled 8,952 bottles of Olopatadine Hydrochloride Ophthalmic Solution on October 9, 2025. The solution exceeded impurity specifications, posing a health risk. Consumers should stop using the product immediately and contact their healthcare provider.

USV Private
Failed Impurities/Degradation
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HIGHFDA DEVICE

Glycar SA Recalls Pericardial Patch Over Strength Issues

Glycar SA Pty. recalled 18 units of the SJM Pericardial Patch on October 9, 2025. The affected lot may not meet required tensile strength specifications. Healthcare providers and patients should stop using this device immediately.

Glycar SA Pty.
The impacted
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HIGHFDA DRUG

Zydus Lifesciences Recalls Tavaborole Topical Solution Over Discoloration

Zydus Lifesciences recalled 13,080 bottles of Tavaborole topical solution on October 6, 2025, due to discoloration. The recall affects products distributed nationwide in the USA. Consumers must stop using the product immediately and contact their healthcare providers for guidance.

Zydus Lifesciences
Discoloration -
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HIGHFDA DEVICE

ICU Medical Recalls IV Administration Sets Over High Hazard Risk

ICU Medical recalled 23,203 IV administration sets on October 2, 2025. The sets lack an internal shutoff valve, risking fluid over-delivery and air infusion. This recall affects devices distributed worldwide, including the U.S., Canada, Australia, and New Zealand.

ICU Medical
IV Gravity
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HIGHFDA DRUG

ZICAM Medicated Fruit Drops Recalled Due to Labeling Error

Church & Dwight Co., Inc. recalled 21,912 bottles of ZICAM Medicated Fruit Drops on October 1, 2025. The recall stems from a labeling mix-up that failed to disclose elderberry as an ingredient. Consumers should stop using the product immediately.

ZICAM COLD REMEDY MEDICATED FRUIT DROPS - ELDERBERRY
Labeling: Label
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HIGHFDA DEVICE

B BRAUN MEDICAL Recalls Hemodialysis Bloodlines Over Air Bubble Risk

B BRAUN MEDICAL recalled 1,298,454 hemodialysis bloodlines on September 30, 2025. The recall results from the risk of micro-air bubbles due to damaged connectors. Patients should stop using the product immediately and follow the manufacturer’s instructions.

B BRAUN MEDICAL
The potential
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HIGHFDA DEVICE

SHENZHEN ATOMSTACK TECHNOLOGIES Recalls Laser Products Over Safety Hazard

SHENZHEN ATOMSTACK TECHNOLOGIES recalled material processing laser products on September 30, 2025, due to a missing remote interlock connector. This defect poses a high risk according to federal regulations. Consumers should stop using these devices immediately and follow manufacturer instructions for remedy.

SHENZHEN ATOMSTACK TECHNOLOGIES
Lack of
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HIGHFDA DRUG

Acuity Specialty Products Recalls Hand Sanitizer Due to Methanol Risk

Acuity Specialty Products recalled its Wyandotte Sanifect E3 hand sanitizer on September 29, 2025. The recall affects multiple package configurations due to potential methanol contamination. Consumers should stop using the product immediately and contact the company for guidance.

Acuity Specialty Products
cGMP deviations:
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HIGHFDA DRUG

AFCO Hand Sanitizer Recalled Due to Methanol Risk

AFCO recalled hand sanitizer on September 29, 2025, due to a risk of methanol contamination. The company failed to conduct required testing on incoming alcohol components. Consumers should stop using the product immediately.

AFCO
cGMP deviations:
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HIGHFDA DRUG

Medline Recalls Alcohol Prep Pads Due to Subpotency Risk

Medline Industries recalled 222,800 boxes of alcohol prep pads on September 29, 2025. The recall follows concerns the product may not meet potency standards. Consumers must stop using the pads and seek guidance from healthcare providers.

Medline Industries, LP
Subpotent Drug
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HIGHFDA DEVICE

Philips Medical Systems Recalls Zenition 50 X-Ray Systems Due to Imaging Issues

Philips Medical Systems Nederland B.V. recalled 29 Zenition 50 x-ray systems on September 29, 2025. The devices may suffer from corrosion of the Image Intensifier Television control board, leading to poor image quality. Users must stop using the device immediately and follow the recall instructions.

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Over time
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