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 DRUG

CA Botana Recalls Doctor D. Schwab Cream Over Quality Issues

CA Botana International recalled 470 tubes of Doctor D. Schwab Controlling Cream on October 10, 2025. The recall stems from CGMP deviations that pose a high hazard risk. Consumers should stop using the product and seek guidance from healthcare providers.

CONTROLLING CREAM
CGMP Deviations
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HIGHFDA DRUG

Doctor D. Schwab Controlling Balm Recalled for CGMP Deviations

CA BOTANA recalled 555 tubes of Doctor D. Schwab Controlling Balm on October 10, 2025, due to CGMP deviations. The affected product contains salicylic acid and tea tree oil. Consumers should stop using the balm immediately and contact CA BOTANA International for guidance.

CONTROLLING BALM WITH TEA TREE OIL
CGMP Deviations
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HIGHFDA DRUG

Major Pharmaceuticals Recalls Gabapentin Capsules Over Impurity Risk

Major Pharmaceuticals recalled Gabapentin Capsules, USP, 100 mg on October 10, 2025, due to failed stability testing. The recall affects capsules packaged in blister packs and sold nationwide. Consumers must stop using the product immediately and seek guidance from healthcare providers.

GABAPENTIN
Failed Impurities/Degradation
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HIGHFDA DRUG

Doctor D. Schwab Sunscreen Recalled Due to CGMP Deviations

Doctor D. Schwab recalled 805 tubes of Shimmery Sun Lotion Sunscreen SPF 30 on October 10, 2025. The recall follows significant deviations from current good manufacturing practices (CGMP). Consumers should stop using the product immediately and contact CA BOTANA for guidance.

SHIMMERY SUN
CGMP Deviations
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HIGHFDA DRUG

CA Botana Recalls Doctor. D. Schwab Mineral Sunscreen Over CGMP Violations

CA Botana International recalled 1,167 tubes of Doctor. D. Schwab Mineral Sunscreen SPF 50 on October 10, 2025. The recall stems from current good manufacturing practices (CGMP) deviations. Affected products include Lot Code D54596 with an expiration date of January 31, 2028.

MINERAL SUNSCREEN
CGMP Deviations
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HIGHFDA DRUG

Lannett Company Recalls Niacin Tablets for Failed Dissolution

Lannett Company, Inc. recalled 46,848 bottles of Niacin Extended-release Tablets on October 10, 2025. The recall follows reports of failed dissolution specifications, which could affect medication effectiveness. Consumers should stop using the product immediately and consult healthcare providers for guidance.

NIACIN
Failed Dissolution
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HIGHFDA DRUG

CLEARSTEM Sunscreen Recalled Due to CGMP Deviations

CLEARSTEM recalled 4,890 bottles of YOU ARE SUNSHINE SPF 50 sunscreen on October 10, 2025. The recall follows concerns over CGMP deviations. Consumers should stop using the product immediately and contact their healthcare provider for guidance.

VISAGE
CGMP Deviations
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HIGHFDA DRUG

Doctor D. Schwab Pain Relief Gel Recalled Due to CGMP Violations

Doctor D. Schwab recalled 810 tubes of Clinical Weh Weh Natural Pain Relief Gel on October 10, 2025. The recall stems from CGMP deviations that could compromise product safety. The affected product was distributed in California, Colorado, Florida, Puerto Rico, and Washington.

WEH-WEH PAIN RELIEVER GEL
CGMP Deviations
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HIGHFDA DRUG

CA Botana Recalls Ultra Umbrella Sunscreen Due to CGMP Violations

CA Botana International, Inc. recalled 874 tubes of Ultra Umbrella Sunscreen SPF 30 on October 10, 2025. The recall stems from CGMP deviations that may affect product safety. Consumers in CA, CO, FL, PR, and WA should stop using the product immediately.

ULTRA UMBRELLA
CGMP Deviations
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HIGHFDA DRUG

Elixir by Coco March Sunscreen Recalled Over CGMP Violations

VitaTienda Co U.S.A. recalled 3,295 bottles of Elixir by Coco March Mineral Sunscreen SPF 50 on October 10, 2025. The recall stems from CGMP deviations that could affect product safety. Consumers should stop using the sunscreen immediately and contact their healthcare provider for guidance.

SUNSCREEN
CGMP Deviations
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HIGHFDA DRUG

CA Botana Recalls Tinted Moisturizer Over CGMP Deviations

CA Botana International recalled 1,401 tubes of Doctor D. Schwab Flawless Skin Fluid Tinted Moisturizer on October 10, 2025. The product may not meet current Good Manufacturing Practices (CGMP). Consumers should stop using it immediately and contact the company for guidance.

SUNSCREEN FLAWLESS SKIN FLUID TINTED
CGMP Deviations
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HIGHFDA DRUG

Dr. Bump Pain Relief Gel Recalled Due to Manufacturing Issues

Dr. Bump Natural Pain Relief Gel has been recalled due to CGMP deviations. 4,890 bottles are affected, distributed in California, Colorado, Florida, Puerto Rico, and Washington. Consumers should stop using the product immediately and contact their healthcare provider for guidance.

DR BUMP GEL 4
CGMP Deviations
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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 DEVICE

Thoratec Recalls CentriMag Blood Pump Over Serious Hazard

Thoratec recalled 8,399 CentriMag Blood Pumps on October 10, 2025, due to a significant malfunction risk. The blood pump may not securely lock into the motor, potentially leading to serious health complications. The recall affects models distributed worldwide, including across the United States and several countries.

Thoratec
Acute circulatory
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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 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

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

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

C-RAD POSITIONING AB Recalls Catalyst Device Over Treatment Risks

C-RAD POSITIONING AB recalled 189 Catalyst and Catalyst+ devices on October 9, 2025, due to issues with stereotactic radiosurgery (SRS) treatment. The defect may lead to incorrect patient positioning, potentially compromising treatment effectiveness. The recall affects devices distributed across 37 countries, including the United States.

C-RAD POSITIONING AB
Due to
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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:
Read more
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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