MedWatch Safety Alerts
The FDA is Recommending Transition to Duodenoscopes with Innovative Designs to Enhance Safety: FDA Safety Communication
FDA is sharing recommendations and updates to help improve duodenoscope reprocessing
Surgical Gowns and Packs by Cardinal Health: FDA Statement - Potential Quality Issues Affecting Some of its Level 3 Surgical Gowns and Accompanying PreSource Procedural Packs
The medical device manufacturer Cardinal Health alerted its customers to potential quality issues affecting some of its Level 3 surgical gowns and accompanying PreSource procedural
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
FUSION IV Pharmaceuticals, Inc dba. AXIA Pharmaceutical is voluntarily recalling all unused sterile drug products within expiry, to the user level, due to a lack of assurance of
Belviq, Belviq XR (lorcaserin): Drug Safety Communication - Due to Possible Increased Risk of Cancer
FDA is alerting the public that results from a clinical trial assessing safety show a possible increased risk of cancer with the weight management medicine Belviq, Belviq XR (
Stryker Launches Voluntary Field Action for Specific Units of The LIFEPAK® 15 Monitor/Defibrillator
Stryker announced today that the company is launching a voluntary field action on specific units of the LIFEPAK 15 monitor/defibrillators
Taro Pharmaceuticals U.S.A., Inc. Issues Voluntary Nationwide Recall of Lamotrigine Tablets USP, 100 mg, 100 Count Bottles
Taro Pharmaceuticals U.S.A., Inc. (“Taro” or the “Company”) is voluntarily recalling one (1) lot of Lamotrigine 100 mg Tablets, Lot # 331771 (expiration date June 2021) in 100
Mavidon Issues Voluntary Worldwide Recall of Manufactured Products Including Lemonprep® Tubes And Single Use Cups Pediaprep® Tubes And Single Use Cups Wave Prep® Tubes And Single Use Cups Cardio Prep Single Use Cups Due To Burkholderia Cepacia Contamination
Mavidon is voluntarily recalling all lots of products manufactured at our facility including LemonPrep®, PediaPrep® and Wave Prep 4-ounce tubes and single use cups, Cardio Prep
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 Manufactured by Solara Active Pharma Sciences Limited
Mylan N.V. (NASDAQ: MYL) today announced that its U.S. based Mylan Pharmaceuticals business is conducting a voluntary nationwide recall, to the consumer level, of three lots of
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
Denton Pharma, Inc. dba Northwind Pharmaceuticals, an affiliate of Northwind Pharmaceuticals, LLC (“Northwind”) today announced the voluntary recall of all unexpired lots of
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)
Appco Pharma LLC (Appco) is voluntarily recalling all quantities and lots, within expiry, of Ranitidine Hydrochloride Capsules to the Consumer level. Ranitidine Hydrochloride
LivaNova Recalls VNS Therapy SenTiva Generator Due to Reset Error
LivaNova is recalling the VNS Therapy SenTiva Generator System due to an unintended reset error that causes the system to stop delivering VNS therapy
Aurobindo Pharma USA, Inc. Issues Voluntary Nationwide Recall of Mirtazapine Tablets Lot Number 03119002A3 Due to Label Error on Declared Strength
Aurobindo Pharma USA, Inc. is voluntarily recalling lot number 03119002A3 of Mirtazapine Tablets to the consumer level. The product is being recalled due to a label error on
2019 Medical Device Recalls
The list below contains recalls that were issued in 2019
Neurontin, Gralise, Horizant (gabapentin) and Lyrica, Lyrica CR (pregabalin): Drug Safety Communication - Serious Breathing Problems
FDA is warning that serious breathing difficulties may occur in patients using gabapentin or pregabalin who have respiratory risk factors
Smiths Medical ASD, Inc. Recalls Medfusion® 4000 Syringe Pumps Due to Malfunctioning Alarms and Potential Interruption of Therapy
The software updates could cause alarms to stop working and cause the battery to drain without warning and potentially interrupt therapy, which could lead to serious injury or
Lannett Issues Voluntary Nationwide Recall of Levetiracetam Oral Solution, 100mg/Ml Due to Microbial Contamination
Lannett Company, Inc. today announced that it is voluntarily recalling two (2) lots of Levetiracetam Oral Solution, 100mg/mL to the consumer level due to contamination with
GE Healthcare Recalls Giraffe Incubators and OmniBeds Due to Potential for Infants to Fall
The bedside panels and portholes can appear closed without being latched, no longer protect the infant from falling
Motto International Corp. Issues Voluntary Recall of Bull Platinum 30000, Stallion Platinum 30000, Rhino 7 Platinum 30000, and Panther Platinum 30000, Due to Presence of Undeclared Tadalafil
Motto International Corp. is voluntarily recalling all lots of Bull Platinum 30000, Stallion Platinum 30000, Rhino 7 Platinum 30000, and Panther Platinum 30000, to the consumer
Cook Medical Recalls CrossCath® Support Catheters Due to a Manufacturing Error Which May Cause the Marker Bands to Dislodge or Cause Buckling
FDA classifies Class I recall for Cook Medical CrossCath® Support Catheters due to radiopaque marker bands being too loose or too tight on certain catheters
Glenmark Pharmaceuticals Inc., USA Voluntarily Recalls All Unexpired Lots of its Ranitidine Tablets and Ceases Distribution, Due to Possible Presence of N-nitrosodimethylamine (NDMA) Impurity
Glenmark Pharmaceutical Inc., USA (“Glenmark”) today announced the voluntary recall of all unexpired lots of Ranitidine Tablets, 150 mg and 300 mg, to the consumer level
