Archive
519 recalls were announced in September 2021.
Of the 519 recalls this month scored against our rubric, 1% are Critical, 20% are Severe.
Which agencies issued them
Avrio Health L.P. is recalling Betadine Solution Swabstick in single and three-count packages nationwide because the product is subpotent—meaning it contains less active ingredient than specified. Consumers should stop using affected lots and consult their healthcare provider if needed.
The Harvard Drug Group is recalling Entacapone 200 mg tablets distributed in Colorado, Florida, Missouri, and Ohio due to failed dissolution specifications that may affect drug efficacy.
Pfizer is recalling Chantix (varenicline) tablets nationwide due to the presence of N-nitroso-varenicline impurity above FDA's acceptable interim intake limit, a manufacturing deviation.
Ad-Tech Medical Instrument Corporation is recalling TECH ATTACH Cables due to incorrect labeling. The cables connect electrodes to third-party monitors and stimulators.
Glenmark Pharmaceuticals is recalling Chlorzoxazone 750 mg tablets nationwide due to current good manufacturing practice (CGMP) deviations. The voluntary recall affects 4,752 bottles with five affected lot numbers.
Morton Grove Pharmaceuticals is recalling Promethazine Syrup Plain 6.25 mg/5 mL in 1-pint bottles due to potential microbial contamination in liquid sugar batches used during manufacturing.
Pfizer is recalling specific lots of Chantix (varenicline) 1 mg tablets nationwide due to the presence of N-nitroso-varenicline impurity above FDA's acceptable interim intake limit. The affected lots were distributed nationwide.
The Harvard Drug Group is recalling Carbamazepine 200mg tablets (Lot R01562, expiring 10/2022) distributed in North Carolina because they failed to meet required dissolution specifications, which may affect the drug's effectiveness.
Morton Grove Pharmaceuticals is recalling Valproic Acid Oral Solution (250 mg/5 mL) due to potential microbial contamination in liquid sugar batches used during manufacturing.
Glenmark Pharmaceuticals is recalling Zonisamide Capsules 50 mg nationwide due to manufacturing deviations. The recall affects approximately 15,936 bottles across multiple lots with expiration dates in May 2022.
Sysco Atlanta is recalling Fleischmann's Yeast Compressed Fresh in 24/1 lb packages because the product was not stored at appropriate temperatures, creating potential food safety risk.
Microbiologics Inc is recalling 218 units of SARS-CoV-2 process control pellets (catalog HE0062S) used to validate diagnostic tests. The FDA Class II recall involves product composition regarding RNA transcript content.
Sysco Atlanta is recalling Sunny Creek and Bloomsbury Organic Farm alfalfa sprouts sold in Georgia, North Carolina, and Tennessee because the product was not held at appropriate temperatures and may be unsafe to consume.
Direct Rx is recalling Zonisamide 100 mg Capsules (30-count bottles, Lot #17JU2118, expiration 5/31/23) distributed in Florida due to gaps in the quality system in the Quality Control microbiology laboratory.
Glenmark Pharmaceuticals is recalling 9,552 bottles of Naproxen Sodium Tablets USP 275 mg nationwide due to CGMP (current Good Manufacturing Practice) deviations identified at the manufacturing facility.
Pfizer is recalling Chantix (varenicline) 1 mg tablets distributed nationwide due to the presence of N-nitroso-varenicline impurity above the FDA's acceptable interim intake limit. Affected lots have expiration dates from September 2021 to December 2023.
Glenmark Pharmaceuticals Inc., USA is voluntarily recalling Zonisamide Capsules USP 100 mg nationwide due to CGMP (Current Good Manufacturing Practice) deviations. The recall affects multiple lot numbers distributed from August 2021.
North American Rescue is recalling 51,424 units of 10 ga ARS Decompression Needles due to incorrect Instructions for Use. Affected parties should stop using and contact manufacturer.
Glenmark Pharmaceuticals is recalling specific lots of Naproxen Sodium 550 mg tablets nationwide due to manufacturing deviations. The firm initiated the voluntary recall on August 27, 2021.
Microbiologics Inc is recalling its SARS-CoV-2 Process Control (Swab) because certain lot numbers were contaminated with plasmid DNA containing SARS-CoV-2 sequences. The affected product was distributed in the United States and internationally.
Sysco Atlanta, LLC is recalling I Siciliani Primosale Pepato sheep's milk cheese because it was not held at appropriate temperatures, potentially making it unsafe to consume.
Sysco Atlanta recalled Gordo's Authentic Mexican Restaurant Style Cheese Dip because the product was not held at the appropriate temperature, making it potentially unsafe to consume.
Sysco Atlanta is recalling Phillips Majestic Blue pasteurized crab meat because the product was not held at appropriate temperatures and may be unsafe to consume.
Sysco Atlanta is recalling Daiya vegan cheddar cheese slices because the product was not held at an appropriate temperature. Affected lots shipped to GA, NC, and TN between July and August 2021 may be unsafe to consume.
Espi's Sausage and Tocino Co. is recalling frozen ready-to-eat chicken and pork hot dogs due to possible Listeria monocytogenes contamination.
Tiffin Motorhomes is recalling 2018-2022 Wayfarer RVs because the rear water tank mounting bolts can fail, causing the tank to fall onto the exhaust pipe. This affects vehicle stability and increases crash risk.
Thor Motor Coach is recalling 2022 Rize and Scope motorhomes due to an LP gas line that may be too short and improperly installed. A gas leak from a ruptured line could cause a fire.
Entegra Coach is recalling certain 2021-2022 Anthem, Aspire, and Reatta XL Class A motorhomes with Cummins diesel engines due to fuel hoses that may leak and pose a fire risk. Owners should contact Entegra customer service at 1-800-283-8267 for free replacement.
Thor Motor Coach is recalling 2021-2022 Omni and Magnitude motorhomes due to an LP gas line routing defect. The line may be incorrectly routed through the rear suspension leaf springs, potentially causing a gas leak and fire risk.
Rosenbauer America is recalling specific 2020-2022 fire trucks because improperly crimped lifting cables may detach, causing the generator set to fall and increasing injury risk.
Thor Motor Coach is recalling 2021-2022 Venetian motorhomes because improperly installed patio awnings may separate while driving, increasing crash risk.
Shyft Group is recalling 2020-2022 Spartan K3 and K4 RVs because a machining defect may cause the power steering pump shaft seal to break, resulting in a loss of power steering assist.
Toyota is recalling 2019-2020 Yaris vehicles because a fuel pump impeller may crack, potentially causing engine stalls and increasing crash risk.
Mazda is recalling certain 2020-2021 CX-9 vehicles with 60/40 split bench second-row seats. The left-side second-row seat may unexpectedly slide forward during a crash, increasing injury risk to occupants.
Nestle is recalling approximately 27,872 pounds of frozen DiGiorno Crispy Pan Crust Pepperoni Pizza because some cartons contain undeclared soy protein.
Ajinomoto Foods North America is recalling raw, frozen chicken and vegetable potstickers that may contain clear flexible and hard plastic.
Carson Trailer is recalling 2021 Carson Carrier trailers because improperly tightened spindle nuts may cause axle vibration and bearing overheating, increasing crash risk.
Motor Coach Industries is recalling specific 2017-2021 motorcoaches because a circuit board in the battery compartment may fail, potentially causing a fire or unexpected shutdown.
Hyundai is recalling 2015-2017 Sonata models because a software defect may cause turn signals to activate in the opposite direction, increasing crash risk.
Forest River Wildwood and Salem fifth wheel trailers from 2021-2022 are recalled due to incorrect Gross Vehicle Weight Rating (GVWR) listed on the Federal Placard. An overloaded pin box can fail, increasing the risk of a crash.
Mazda is recalling 2006-2007 MazdaSpeed6 and 2009-2011 RX-8 vehicles because fuel may leak from the pump mounting rings, increasing fire risk.
The Boppy Company is recalling approximately 3.3 million Boppy newborn loungers due to suffocation risk. Eight infant deaths have been reported associated with the product.
Braun Ambulances is recalling 2020-2021 Demers MXP153 vehicles because damaged electrical wires and oxygen tubes may increase fire risk.
Altec is recalling 2011-2016 AT200A aerial devices because cracks in the mounting frame legs may cause the side plate to break, increasing injury risk.
Volkswagen is recalling 2018 Tiguan vehicles because an incorrect roof reinforcement assembly may have been installed during prior repairs, potentially compromising structural integrity and airbag deployment.
Nissan is recalling 2022 Pathfinder vehicles because the third-row headrests may move or detach due to improper welds or misaligned components. Detached headrests could fail to restrain occupants in a crash, increasing injury risk.
DRV Suites is recalling 2018-2021 Elite and Mobile Suites because brake caliper clips may bend, causing the caliper to unseat and increasing crash risk.
Daimler Trucks North America is recalling 2015-2018 Thomas Built Minotour school buses because a corroded solenoid connector may cause an electrical short, leading to fire.
Nissan is recalling certain 2022 Pathfinder vehicles because the second-row seat back frames may have insufficient welds that could separate. This could cause seats to fail to restrain occupants properly during a crash, increasing injury risk.
Ready Pac Foods is recalling ready-to-eat salads containing meat and poultry because they include salad dressing with an undeclared anchovy allergen.
General Motors is recalling certain 2021 Chevrolet Tahoe vehicles due to a fuel pump power control module defect that may cause engine stalls, increasing crash risk.
Motor Coach Industries is recalling 2005-2012 MCI J4500 and E4500 motorcoaches because the wheelchair lift's outer barrier may fail under force, increasing injury risk.
Ducati is recalling 2019 Hypermotard 950 SP motorcycles because the side stand may be improperly welded. A broken stand could cause the motorcycle to fall, increasing injury risk.
Polaris is recalling about 13,000 model year 2011–2021 Phoenix 200 ATVs because the throttle speed control stop can break and become stuck, posing a crash hazard. The company has received 18 reports of throttle stop failure including one crash with minor injury.
Purim Health Products EpiGenius Kids Creamy Chocolate powder is recalled due to undeclared milk in an MCT powder ingredient. The product was not labeled to indicate the presence of milk, which is a common allergen.
Jimmy's Cookies, LLC is recalling Marketside Chocolate Candy Cookie Cake (24 oz., Lot# 1133) because the product contains undeclared peanuts, posing a serious risk to consumers with peanut allergies.
Hydro Pineapple Burn Max Health supplement sachets are being recalled because they contain undeclared sibutramine and were marketed without FDA approval. The product was distributed nationwide.
Ford is recalling 2011-2013 Explorers in 23 states and D.C. because a rear suspension part may fracture, causing loss of steering control.
Cordis Corporation recalls SUPER TORQUE MB angiographic catheters worldwide due to risk of entrapment between endovascular devices and vessel wall, potentially causing marker band dislodgement.
Loki Fish Company is recalling Loki Fish Wild Keta Salmon Lox (4 oz. pouches, UPC 92103 00111) distributed in Oregon and Washington due to potential Listeria monocytogenes contamination.
Weis Markets is recalling $7 Crab Cake Meals because they contain undeclared milk, a common allergen. The product was distributed to retail locations in Maryland, Pennsylvania, New Jersey, and West Virginia.
Full Tilt Ice Cream, LLC is recalling Dark Chocolate ice cream in 16oz pints and 3-gallon tubs because the ice cream mix did not meet pasteurization specifications. The product was distributed in Washington.
Cordis is recalling its SUPER TORQUE MB Angiographic Catheter worldwide because it may become entrapped between endovascular devices and the vessel wall. This entrapment can cause marker band movement or dislodgement.
Armstrong Medical Services Limited is recalling AMSORB PLUS PREFILLED anesthesia canisters due to risk of high resistance to gas flow that could prevent adequate ventilation. Not all defective units will be detected by standard pre-use testing.
Whole Foods Market is recalling Vegan Croissant 4 Count packages due to undeclared milk and egg allergens. The product was distributed in Georgia.
Greenpark Compounding Pharmacy is recalling Spironolactone Ophthalmic Solution 0.005 mg/mL due to lack of assurance of sterility. The 15 mL bottles were distributed nationwide.
ICU Medical Inc is recalling AMINOSYN II 15% An Amino Acid Injection due to the presence of particulate matter including fibers, hair, and proteinaceous material found in retained samples.
Florance Morris ANTISEPTIC Hand Sanitizer (70% ethyl alcohol) in 8.45 fl oz and 33.81 fl oz bottles is being recalled due to methanol contamination found in some lots. All lots are affected due to manufacturing under the same conditions as contaminated products.
Florance Morris ANTISEPTIC Hand Sanitizer (70% ethyl alcohol) distributed nationwide is recalled due to FDA-detected methanol contamination and insufficient ethanol content. The product was distributed by Asimex International LLC in Florida.
Teligent Pharma is recalling Lidocaine Hydrochloride Topical Solution, USP 4% due to the product being superpotent. The recall affects 32,544 bottles distributed nationwide in the United States and Canada.
Promise Pharmacy is recalling MIC+Methyl B12 injection (57 vials, Lot# 06152021@2) distributed across five states due to lack of processing controls that may affect product quality and safety.
Cordis is recalling approximately 1,610 SUPER TORQUE PIG PIGTAIL SPECIAL angiographic catheters worldwide because the device can become entrapped between endovascular devices and the vessel wall, potentially causing marker band movement or dislodgement.
Cordis is recalling angiographic catheters that may become entrapped between devices and vessel walls, risking marker band dislodgement during vascular procedures. Approximately 71,330 units were distributed worldwide.
Cordis is recalling the SUPER TORQUE MB angiographic catheter (18,730 units) due to risk of entrapment between endovascular devices and vessel wall, which can cause marker band movement or dislodgement. Units were distributed worldwide.
Naturo Aid Pharmaceutical Inc. is recalling Vita Aid Keto-Elemental Nutrition (Chocolate) powder due to undeclared milk contamination. The product may pose a risk to consumers with milk allergies.
Roche Diagnostics is recalling cobas infinity central lab software versions 3.01.03–3.02.08 because under certain circumstances, the software may automatically send false test results to laboratory information systems. Correct results remain available on the instrument.
Full Tilt Ice Cream is recalling Thai Tea ice cream in 16oz pints and 3-gallon tubs because the ice cream mix did not meet pasteurization specifications, creating a risk of harmful bacterial contamination.
CAREFUSION is recalling BD SmartSite needle-free connector valves due to difficulty flushing, flow issues, and occlusions that could delay therapy. Approximately 23.8 million units were distributed worldwide.
BD Syringe Set needle-free connector valves may experience difficulty flushing, flow issues, or occlusions that could delay patient therapy. About 16,700 units have been distributed worldwide.
Huish Outdoors is recalling Oceanic Adult Dry Top Snorkels sold at Costco because the bottom purge valve can leak, allowing unexpected water entry that poses a drowning hazard. Consumers should stop using the snorkels immediately.
Gibson Bioscience is recalling Potassium Hydroxide 10% diagnostic reagent kits (Lot 21137116, 11 units) manufactured with Hydrogen Peroxide 3% instead of the intended chemical. The wrong solution could cause inaccurate laboratory test results.
Jimbo's Kitchen is recalling Jimbo's Bloody Mary Mix because the product contains soy, sulfites, and wheat that are not declared on the ingredient label, posing a risk to consumers with allergies or sensitivities.
CareFusion recalls BD SmartSite needle-free valve extension sets due to potential occlusion, flow issues, and difficulty flushing that could delay medical therapy.
BD Gravity Burette Sets and Add-On Burette Sets are being recalled due to needle-free connector valve defects that may cause flushing difficulties, flow problems, or complete occlusions, potentially delaying therapy. The recall affects approximately 77,802 units distributed worldwide.
CareFusion is recalling BD SE Burette Sets with needle-free connector valves that may fail to flush or develop flow obstructions, risking therapy delays. Approximately 56,680 units were distributed worldwide.
Full Tilt Ice Cream is recalling Vanilla Bean ice cream in pints and tubs because the ice cream mix did not meet pasteurization specifications, which could allow harmful bacteria to survive.
Full Tilt Ice Cream is recalling Mexican Chocolate ice cream in pints and tubs distributed in Washington because the ice cream mix did not meet pasteurization specifications.
Abbott's Alinity ci-series analyzers with software version 3.2.3 and earlier have multiple issues that could display expired reagents as valid, fail to alert operators to errors, and produce incorrect test results.
Braun ThermoScan PRO 6000 ear thermometers may overheat if exposed to fluids and used before drying, risking burns to the user or patient. More than 1 million units are affected.
Full Tilt Ice Cream is recalling Peanut Butter Chip ice cream in 3-gallon tubs distributed in Washington because the ice cream mix did not meet pasteurization specifications.
Full Tilt Ice Cream is recalling Mint Chip ice cream in 3-gallon tubs distributed in Washington because the ice cream mix did not meet pasteurization specifications.
BD needle-free connector valves and extension sets may experience flow obstruction and flushing difficulties, potentially delaying medical therapy. No adverse events have been reported.
Naturo Aid Pharmaceutical Inc. is recalling Vita Aid SynerClear (Unflavoured) powder because it may contain undeclared milk residue. Consumers with milk allergies are at risk.
Hero Health is recalling the Model 100 smart pill dispenser due to a software defect causing the device to prompt users to take medication doses that have already been dispensed, creating overdose risk.
Full Tilt Ice Cream is recalling Strawberry ice cream in 16oz pints and 3-gallon tubs because the ice cream mix did not meet pasteurization specifications. Products distributed in Washington with Julian dates of 20621X and earlier, or tub dates of 7/26/21 and earlier, are affected.
Philips Azurion medical imaging devices may fail when powered by hospital electrical systems providing 480V. The failure reduces X-ray performance and may be preceded by a burning smell.
Naturo Aid Pharmaceutical is recalling Vita Aid Keto-Elemental Nutrition (Thai) powder because it may contain undeclared milk residue. The product was distributed across ten U.S. states.
Arjohuntleigh recalls 62 Maxi Sky 1000 and V10 bariatric ceiling lifts because the spreader bar can disconnect from the scale attachment. Users should immediately stop using affected units and contact the manufacturer.
Getinge recalled 46,085 Arjo Disposable Repositioning Sling units because the sling loop straps pose a trip hazard. The affected devices were distributed nationwide to healthcare facilities.
Siemens syngo.CT software used in radiation therapy systems may lose treatment structure data during edit and reopen operations, sending incomplete treatment information to planning systems.
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