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FDA MedWatch Alerts

Dr. Reddy's Laboratories Issues Voluntary Nationwide Recall of Phytonadione Injectable Emulsion USP, 10 mg/mL Single-Dose Ampules Due To Ampules Breaking And Shattering Upon Opening

March 26, 2020 -- Dr Reddy’s Laboratories, Inc has notified its distributors to arrange for return of any recalled product. Wholesalers, distributors,...

FDA Alerts Patients and Health Care Professionals of EpiPen Auto-Injector Errors Related to Device Malfunctions and User Administration

March 24, 2020 -- FDA is alerting patients, caregivers and health care professionals that EpiPen 0.3mg and EpiPen Jr 0.15mg auto-injectors, and the authorized...

Coronavirus (COVID-19) Update: FDA Alerts Consumers About Unauthorized Fraudulent COVID-19 Test Kits

March 20, 2020 -- The U.S. Food and Drug Administration is actively and aggressively monitoring the market for any firms marketing products with fraudulent...

Natural Remedy Store Issues Voluntary Worldwide - Recall of Active Male Due to Presence of Undeclared Tadalafil

March 16, 2020 -- Natural Remedy Store is voluntarily recalling all lots of Active Male, 500mg capsules to the consumer level. FDA analysis has found the...

Singulair (montelukast) and All Montelukast Generics: Strengthened Boxed Warning - Due to Restricting Use for Allergic Rhinitis

ISSUE: FDA is strengthening existing warnings about serious behavior and mood-related changes with montelukast (Singulair and generics), which is a...

FDA Requires Stronger Warning About Risk of Neuropsychiatric Events Associated with Asthma and Allergy Medication Singulair and Generic Montelukast

March 4, 2020 -- The U.S. Food and Drug Administration today announced that it is requiring a boxed warning – the agency’s most prominent warning...

American Health Packaging Issues Voluntary Nationwide Recall of Ranitidine Tablets, USP 150 mg, 100 Count Unit Dose Blisters Due to the Detection of N-nitrosodimethylamine (NDMA) Impurity

February 27, 2020 -- American Health Packaging has voluntarily recalled eleven (11) lots of Ranitidine Tablets, USP 150 mg, 100 count Unit Dose Blisters to the...

Taro Pharmaceuticals U.S.A. Issues Voluntary Nationwide Recall of Phenytoin Oral Suspension USP, 125 mg/5mL Due to Possible Underdosing or Overdosing

February 21, 2020 -- Taro Pharmaceuticals U.S.A., Inc. (“Taro” or the “Company”) is voluntarily recalling two (2) lots of Phenytoin...

Drug Safety Communication: Belviq, Belviq XR (lorcaserin) by Eisai - FDA Requests Withdrawal of Weight-Loss Drug

ISSUE: FDA has requested that the manufacturer of Belviq, Belviq XR (lorcaserin) voluntarily withdraw the weight-loss drug from the U.S. market because a...

Efficient Laboratories, Inc. Issues Voluntary Nationwide Recall of Rompe Pecho EX, Rompe Pecho CF, and Rompe Pecho MAX due to Microbial Contamination

January 31, 2020 -- Efficient Laboratories, Inc. is voluntarily recalling one lot each of Rompe Pecho EX, Rompe Pecho CF, and Rompe Pecho MAX liquid....

Drug Safety Communication: Clozapine (Clozaril, Fazaclo ODT, Versacloz) - FDA Strengthens Warning That Untreated Constipation Can Lead to Serious Bowel Problems

ISSUE: FDA is strengthening an existing warning that constipation caused by the schizophrenia medicine clozapine (Clozaril, Fazaclo ODT, Versacloz, generics)...

FUSION IV Pharmaceuticals, Inc dba. AXIA Pharmaceutical Issues Voluntary Nationwide Recall of All Sterile Drug Products Within Expiry Due to A Lack of Assurance of Sterility

January 16, 2020 -- FUSION IV Pharmaceuticals, Inc dba. AXIA Pharmaceutical is voluntarily recalling all unused sterile drug products within expiry, to the...

Drug Safety Communication: Belviq, Belviq XR (lorcaserin) - Due to Possible Increased Risk of Cancer

ISSUE: The FDA is alerting the public that results from a clinical trial assessing safety show a possible increased risk of cancer with the weight management...

Taro Pharmaceuticals U.S.A., Inc. Issues Voluntary Nationwide Recall of Lamotrigine Tablets USP, 100 mg, 100 Count Bottles

January 10, 2020 -- Taro Pharmaceuticals U.S.A., Inc. (“Taro” or the “Company”) is voluntarily recalling one (1) lot of Lamotrigine 100...

Denton Pharma, Inc. dba Northwind Pharmaceuticals Voluntarily Recalls All Unexpired Lots of its Ranitidine Tablets and Ceases Distribution, Due to Possible Presence of N-Nitrosodimethylamine (NDMA) Impurity

January 8, 2020 -- Denton Pharma, Inc. dba Northwind Pharmaceuticals, an affiliate of Northwind Pharmaceuticals, LLC (“Northwind”) today announced...

Mylan Initiates Voluntary Nationwide Recall of Three Lots of Nizatidine Capsules, USP, Due to the Detection of Trace Amounts of NDMA (N-Nitrosodimethylamine) Impurity Found in the Active Pharmaceutical Ingredient

January 8, 2020 -- Mylan N.V. today announced that its U.S. based Mylan Pharmaceuticals business is conducting a voluntary nationwide recall, to the consumer...

Appco Pharma LLC Issues Voluntary Nationwide Recall of Ranitidine Hydrochloride Capsules 150 mg and 300 mg Due to an Elevated Amount of Unexpected Impurity, N-Nitrosodimethylamine (NDMA)

January 07, 2020 -- Appco Pharma LLC (Appco) is voluntarily recalling all quantities and lots, within expiry, of Ranitidine Hydrochloride Capsules to the...

Aurobindo Pharma USA, Inc. Issues Voluntary Nationwide Recall of Mirtazapine Tablets Lot Number 03119002A3 Due to Label Error on Declared Strength

December 31, 2019 -- Aurobindo Pharma USA, Inc. is voluntarily recalling lot number 03119002A3 of Mirtazapine Tablets to the consumer level. The product is...

Lannett Issues Voluntary Nationwide Recall of Levetiracetam Oral Solution, 100mg/mL Due to Microbial Contamination

December 19, 2019 -- Lannett Company, Inc. today announced that it is voluntarily recalling two (2) lots of Levetiracetam Oral Solution, 100mg/mL to the...

FDA Warns About Serious Breathing Problems with Seizure and Nerve Pain Medicines Gabapentin (Neurontin, Gralise, Horizant) and Pregabalin (Lyrica, Lyrica CR) in Patients with Respiratory Risk Factors

December 19, 2019 -- The U.S. Food and Drug Administration (FDA) is warning that serious breathing difficulties may occur in patients using gabapentin...

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FDA MedWatch Alerts Archive