Archive
519 recalls were announced in September 2021.
Of the 519 recalls this month scored against our rubric, 1% are Critical, 19% are Severe.
Which agencies issued them
Monarch PCM, LLC is recalling Hydroquinone 4% Skin Bleaching Cream due to subpotency affecting the active ingredient assay and preservative assay in one product each.
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.
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.
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.
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.
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 Imperial Fresh diced Roma tomatoes due to improper temperature storage that may have made the product unsafe to consume.
Sysco Atlanta is recalling Ken's Steakhouse Asian Sesame Dressing after the product was not held at appropriate temperatures. The improper storage conditions could make the food unsafe to consume.
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.
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.
Glenmark Pharmaceuticals is recalling 1,800 bottles of Chlorzoxazone Tablets USP 375 mg nationwide due to current Good Manufacturing Practice (CGMP) deviations. The recall was initiated on August 27, 2021.
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.
Sysco Atlanta is recalling Sunny Creek Sprout Bean Fresh in 1/5 lb plastic bags due to improper temperature storage that could make the food 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.
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 is recalling TULKOFF Ginger Puree because the product was not held at appropriate temperatures, making it potentially 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.
Sysco Atlanta is recalling Minor's Seafood Base No MSG GF shipped between July and August 2021 to Georgia, North Carolina, and Tennessee because the product was not held at an appropriate temperature and may be unsafe to consume.
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.
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.
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.
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.
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.
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.
Thor Motor Coach is recalling 2021-2022 Venetian motorhomes because improperly installed patio awnings may separate while driving, increasing crash 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 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.
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.
Toyota is recalling 2019-2020 Yaris vehicles because a fuel pump impeller may crack, potentially causing engine stalls and 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.
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.
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.
Carson Trailer is recalling 2021 Carson Carrier trailers because improperly tightened spindle nuts may cause axle vibration and bearing overheating, 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.
Hyundai is recalling 2015-2017 Sonata models because a software defect may cause turn signals to activate in the opposite direction, increasing crash risk.
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.
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.
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.
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.
Braun Ambulances is recalling 2020-2021 Demers MXP153 vehicles because damaged electrical wires and oxygen tubes may increase fire 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.
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.
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.
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.
Ready Pac Foods is recalling ready-to-eat salads containing meat and poultry because they include salad dressing with an undeclared anchovy allergen.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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 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.
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.
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.
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.
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.
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.
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.
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.
Ford is recalling 2011-2013 Explorers in 23 states and D.C. because a rear suspension part may fracture, causing loss of steering control.
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.
Trader Joe's Raw California Walnut Baking Pieces have been recalled due to mispackaging. Bags labeled as walnut pieces contain a mix of cashews, macadamia nuts, and walnuts.
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.
Naturo Aid Pharmaceutical Inc. is recalling Vita Aid SynerClear (Vanilla) powder because it may contain undeclared milk residue. Consumers with milk allergies are at risk.
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.
Albanese World's Best Mini Gummi Butterflies (7.5oz) contain comingled Olly Sleep dietary supplement that may cause drowsiness. Consumers should not eat the product.
Rhodes Pharmaceuticals is recalling Oxycodone Hydrochloride 10 mg tablets (Lot # WP5K0Y) distributed nationwide after a foreign Hydrochlorothiazide/Lisinopril tablet was found in one bottle.
Full Tilt Ice Cream, LLC is recalling Coffee Oreo ice cream in 3-gallon tubs distributed in Washington because the ice cream mix did not meet pasteurization specifications.
BD Alaris Pump Infusion Buerette Sets with needle-free connector valves may experience flushing difficulties, flow issues, or occlusions that could delay therapy delivery. No illnesses or injuries have been reported.
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.
Naturo Aid Pharmaceutical Inc. is recalling Vita Aid SynerClear (Chocolate) powder because it may contain undeclared milk residue, which poses a hazard to consumers with milk allergies.
Accora Inc is recalling multiple Configura Advance Chair models due to a potential defect where the backrest may detach, creating a fall risk for users.
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.
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.
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.
Ford and Lincoln are recalling 228,297 vehicles with 360-degree cameras because the rearview camera image may fail to display, reducing rear visibility and increasing crash risk.
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.
CareFusion recalls BD SmartSite needle-free valve extension sets due to potential occlusion, flow issues, and difficulty flushing that could delay medical therapy.
CAREFUSION is recalling BD SmartSite Bag Access Device needle-free connector valves due to potential occlusions and flow issues that could delay therapy delivery.
Whole Foods Market is recalling Vegan Croissant 4 Count packages due to undeclared milk and egg allergens. The product was distributed in Georgia.
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.
BD SmartSite needle-free valves may become obstructed, preventing proper fluid flow in medical infusions. The FDA recalls over 295,000 units due to risk of therapy delays.
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.
CAREFUSION is recalling BD Gravity Burette Sets with needle-free connector valves that may develop flow restrictions and blockages, potentially delaying medication delivery. Approximately 29,130 units were distributed.
Siemens radiation therapy planning software may lose data when editing treatment structures. Incomplete structure sets could be sent to the treatment planning system, affecting treatment plan accuracy.
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.
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.
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.
Luminex Corporation is recalling 4,579 Verigene EP Amplification Reagent Kit Test units worldwide due to potential for false positive results. Affected kits distributed across the United States, Austria, France, Greece, Japan, and Turkey may produce incorrect test results.
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.
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