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FDA MedWatch Alerts

Pfizer Inc. Issues a Voluntary Nationwide Recall for 2 Lots of Relpax (eletriptan hydrobromide) 40 mg Tablets Due to Potential Microbiological Contamination of Non-Sterile Products

Pfizer Inc. is voluntarily recalling Relpax (eletriptan hydrobromide) 40 mg tablets, lots AR5407 and CD4565, to the Patient level. Pfizer Inc. initiated this... Read more

August 15, 2019

FDA Review Finds No Increased Risk of Prostate Cancer with Parkinson's Disease Medicines Containing Entacapone (Comtan, Stalevo)

August 13, 2019 -- A U.S. Food and Drug Administration (FDA) review of additional data found no increased risk of prostate cancer with the use of entacapone to... Read more

August 13, 2019

Ridge Properties LLC DBA Pain Relief Naturally Issues Voluntary Nationwide Recall of PRE-TAT , Superior Pain and Itch Relief, and Soothing Sore Relief Cream and Gel Products Due to Microbiological Contamination and Superpotency

August 8, 2019 -- Ridge Properties LLC DBA Pain Relief Naturally is voluntarily recalling 4 lots of 4% lidocaine topical cream & liquid gel products sold at... Read more

August 8, 2019

FDA Approves Boxed Warning About Increased Risk of Blood Clots and Death with Higher Dose of Tofacitinib (Xeljanz, Xeljanz XR)

July 26, 2019 -- The U.S. Food and Drug Administration has approved new warnings about an increased risk of blood clots and of death with the 10 mg twice daily... Read more

July 26, 2019

Jubilant Cadista Pharmaceuticals Inc. Issues Voluntary Nationwide Recall of Drospirenone and Ethinyl Estradiol Tablets, USP, Due to Out-of-Specification Dissolution Test Results

July 23, 2019 -- Salisbury, Maryland, Jubilant Cadista Pharmaceuticals Inc. is voluntarily recalling one lot of Drospirenone and Ethinyl Estradiol Tablets,... Read more

July 23, 2019

FDA Advises Patients Not to Use Herbal Doctor Remedies’ Medicines

July 23, 2019 -- FDA advises patients not to use any drugs manufactured by Herbal Doctor Remedies, Monterey Park, California, because these drugs were made... Read more

July 23, 2019

Bayer Statement on Voluntary Recall of Two Lots of Kogenate FS Antihemophilic Factor (Recombinant) in the United States

Bayer is voluntarily recalling two lots of Kogenate FS antihemophilic factor (recombinant) 2000 IU vials in the United States to the patient level. Certain... Read more

July 19, 2019

Altaire Pharmaceuticals, Inc. Issues Voluntary Recall of Over-The-Counter Ophthalmic Products Sold By Natural Ophthalmics And TRP Company, Inc.

July 16, 2019 -- Altaire Pharmaceuticals, Inc., announces today that it is voluntarily recalling the Over-the-Counter (OTC) drug products and lots, within... Read more

July 16, 2019

Altaire Pharmaceuticals, Inc. Issues Voluntary Recall of Multiple Ophthalmic Products Sold by OCuSOFT

July 16, 2019 -- Altaire Pharmaceuticals, Inc., announces today that it is voluntarily recalling the Prescription (RX) and Over-the-Counter (OTC) drug products... Read more

July 16, 2019

Altaire Pharmaceuticals, Inc. Issues Voluntary Recall of Multiple Over-The-Counter Ophthalmic Products Sold By Accutome, Focus Laboratories, Grandall Distributing Co. Inc. And Prestige

July 16, 2019 -- Altaire Pharmaceuticals, Inc., announces today that it is voluntarily recalling the Over-the-Counter (OTC) drug products and lots, within... Read more

July 16, 2019

Altaire Pharmaceuticals, Inc. Issues Voluntary Recall of Multiple Ophthalmic Products Manufactured and Distributed as Altaire Labeled Products

July 15, 2019 -- Altaire Pharmaceuticals, Inc., announces today that it is voluntarily recalling the over the counter (OTC) and prescription (Rx) drug products... Read more

July 15, 2019

Altaire Pharmaceuticals, Inc. Issues Voluntary Recall Of Multiple Ophthalmic Products Sold At CVS

July 10, 2019 -- Altaire Pharmaceuticals, Inc., announces today that it is voluntarily recalling the Over-the-Counter (OTC) drug products and lots, within... Read more

July 10, 2019

Altaire Pharmaceuticals, Inc. Issues Voluntary Recall of Multiple Ophthalmic Products Sold at Wal Mart

July 5, 2019 -- Altaire Pharmaceuticals, Inc., announces today that it is voluntarily recalling the Over-the-Counter (OTC) drug products and lots, within... Read more

July 5, 2019

Altaire Pharmaceuticals, Inc. Issues Voluntary Recall of Multiple Ophthalmic Products Sold at Walgreens

July 3, 2019 -- Altaire Pharmaceuticals, Inc., announces today that it is voluntarily recalling the Over-the-Counter (OTC) drug products and lots, within... Read more

July 3, 2019

Altaire Pharmaceuticals, Inc. Issues Voluntary Recall of Multiple Ophthalmic Products

July 3, 2019 -- Altaire Pharmaceuticals, Inc., announces today that it is voluntarily recalling the prescription drug products and lots, within expiry,... Read more

July 3, 2019

Fresenius Kabi Issues Voluntary Nationwide Recall of Two Lots of Fluorouracil Injection Due to the Potential for Glass Particulate

July 2, 2019 -- Fresenius Kabi USA, LLC is voluntarily recalling two lots of Fluorouracil Injection, USP 5g/100mL (50mg/mL), 100mL fill in 100mL vials, to the... Read more

July 2, 2019

PharMEDium Services, LLC Issues Voluntary Nationwide Recall of 0.5 mg/mL HYDROmorphone HCl in 0.9% Sodium Chloride 1 mL in 3 mL BD Syringe Due to Presence of Sulfite

June 28, 2019 -- PharMEDium Services, LLC is voluntarily recalling 45 lots of 0.5 mg/mL HYDROmorphone HCl in 0.9% Sodium Chloride 1 mL in 3 mL BD Syringe to... Read more

June 28, 2019

FDA Warns Patients and Health Care Professionals Not to Use Sterile Products from Pacifico National Inc., dba AmEx Pharmacy

June 28, 2019 -- FDA is warning patients and health care professionals not to use products intended to be sterile produced by Pacifico National Inc., doing... Read more

June 28, 2019

Macleods Pharmaceutical Limited Issues Voluntary Nationwide Consumer Level Recall of Losartan Potassium 50mg and Losartan Potassium/Hydrochlorothiazide combination Tablets 50mg/12.5mg, 100mg/12.5mg and 100mg/25mg due to detection of NMBA Impurity

June 26, 2019 -- Macleods Pharmaceuticals Limited has initiated a voluntary recall in the United States, to the patient level, of 32 lots of Losartan Potassium... Read more

June 26, 2019

FDA Updates on Angiotensin II Receptor Blocker (ARB) Recalls

Investigation ongoing – This page to be updated as more information is available IMPORTANT: Medications containing only amlodipine or hydrochlorothiazide (... Read more

June 26, 2019
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FDA MedWatch Alerts Archive