Drug Recalls Center

1,355 pharmaceutical and medication recalls tracked. Stay informed about FDA drug safety alerts, prescription medications, over-the-counter drugs, and dietary supplements.

1,355
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

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

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 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

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 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 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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HIGHFDA DRUG

Dr. Reddy's Laboratories Recalled Succinylcholine Injection Over Safety Concerns

Dr. Reddy's Laboratories recalled 571 vials of Succinylcholine Chloride Injection on September 26, 2025. The recall stems from out-of-specification results during stability testing, indicating a decreased preservative concentration. The product is used for intravenous or intramuscular administration and is available by prescription only.

SUCCINYLCHOLINE
Out-of-Specification (OOS)
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HIGHFDA DEVICE

Synthes Recalls Surgical Screws Due to Labeling Errors

Synthes (USA) Products LLC recalled 122 surgical screws on September 26, 2025. Mislabeling of screw lengths poses a serious risk to patients. Affected products include those used in the RFN-ADVANCED and Tibial Nail Advanced Systems.

Synthes (USA) Products
Although the
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HIGHFDA DEVICE

Synthes Recalls Medical Screws Due to Packaging Errors

Synthes (USA) Products LLC recalled 120 units of medical screws on September 26, 2025. The screws were incorrectly labeled, posing a risk to patients. The recall affects multiple states and Canada.

Synthes (USA) Products
Although the
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Recalled RELIEVE Numbing Cream – Outer Packaging
HIGH
CPSC

Mad Rabbit Recalls "RELIEVE" Numbing Cream Over Poisoning Risk

Mad Rabbit recalled its "RELIEVE" numbing cream on September 25, 2025. This recall affects the product due to non-compliance with child-resistant packaging requirements. The cream poses a risk of serious injury or death from poisoning if ingested by young children.

Mad Rabbit
The numbing
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HIGHFDA DEVICE

DJO Recalls Cold Compression Wrap Over Burn Hazard

DJO recalled 1,594 cold compression wraps on September 25, 2025. The wraps may leak or break when heated in the microwave, posing a burn risk. The recall affects models REF: DP163CT03-BLK-L, XL, and DP163CT02.

DJO
The IFU
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HIGHFDA DEVICE

LeMaitre Vascular Recalls Collagen Vascular Graft Due to Mislabeling Hazard

LeMaitre Vascular recalled one unit of its Collagen Vascular Graft on September 25, 2025. The device was packed in the wrong size labeled outer packaging, posing a high hazard to patients. Health providers and patients should stop using this device immediately and follow the recall instructions.

LeMaitre Vascular
The device
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