Archive
428 recalls were announced in January 2022.
Of the 428 recalls this month scored against our rubric, 1% are Critical, 37% are Severe.
Which agencies issued them
EGL Motor is recalling about 2,900 EGL and ACE branded youth ATVs (models MADIX 125 and D110) because they fail federal safety standards, allowing children to exceed safe speeds and creating laceration and crash hazards.
About 3,500 children's robes made by HulovoX fail federal flammability standards for sleepwear and pose a burn injury risk. The robes were sold online through Amazon.com from January to May 2021 for about $30 each.
Howmedica Osteonics Corp. is recalling Triathlon Pro Tibial Preparation Trays that may contain the wrong surgical instrument. The incorrect component could delay surgery or cause unintended bone preparation during knee replacement procedures.
Joy's International Foods is recalling Joy's Gourmet Blast Off! Bloody Mary Mix (24 oz) due to undeclared fish and soy allergens. Consumers with allergies to these ingredients should not consume the product.
Trader Joe's Soycutash (Item #99319), a frozen mix of sweet corn, shelled edamame, and red bell peppers, is being recalled because it may be contaminated with Listeria monocytogenes. The recall affects products distributed in Arizona, California, Nevada, and Utah.
Abbott Molecular is recalling 742 Alinity m System diagnostic devices worldwide due to potential for abnormal amplification curves that could affect test accuracy.
Perrigo Company PLC is recalling TopCare Allergy Relief Fexofenadine Hydrochloride 180mg tablets in multiple pack sizes due to failed impurity specifications during stability testing. The affected lots were distributed nationwide.
Perrigo Company is recalling Wal-Fex Fexofenadine Hydrochloride 60mg tablets due to out-of-specification impurity levels detected during stability testing. The recall affects 4,536 containers distributed nationwide.
Perrigo Company PLC is recalling Fexofenadine Hydrochloride 180mg antihistamine tablets due to an out-of-specification impurity result detected during stability testing. The recall affects approximately 89,664 containers distributed nationwide.
Tapemark's iontoPATCH On-the-Go patches contain incorrect dosage information printed on the pouch label, though the primary carton label is correct. Approximately 5,141 cartons were distributed nationwide.
Perrigo Company PLC is recalling basic+care allergy Fexofenadine Hydrochloride Tablets (180 mg, 150-count bottles) distributed nationwide because impurity testing results exceeded specification limits during stability testing.
Ascend Laboratories recalls Cefixime 400 mg capsules due to failed impurities and degradation specifications. The affected 42,698 bottles were distributed nationwide.
Perrigo Company PLC is recalling GoodSense Aller.Ease fexofenadine hydrochloride 60 mg tablets nationwide due to failed impurity and degradation specifications identified during stability testing.
CVS Allergy Relief Fexofenadine Hydrochloride Tablets 60 mg are being recalled because stability testing found an out-of-specification result for impurity A. The recall affects approximately 138,144 containers distributed nationwide.
Perrigo Company PLC is recalling Fexofenadine Hydrochloride 60mg antihistamine tablets (100-count bottles) nationwide due to failed impurity specifications found during stability testing. The recall affects 41,472 containers distributed in the USA.
Perrigo Company is recalling Kroger Allergy Relief Fexofenadine Hydrochloride 60mg tablets due to an out-of-specification impurity detected during stability testing.
Perrigo Company is recalling Health Mart Fexofenadine Hydrochloride 180mg antihistamine tablets due to failed impurity specifications detected during stability testing. The recall affects approximately 6,960 containers distributed nationwide.
RemedyRepack Inc. is recalling Cefixime 400 mg capsules distributed in Michigan and Pennsylvania due to failed impurities and degradation specifications. The affected products may not meet established quality and safety standards.
Perrigo Company PLC is recalling up&up allergy relief fexofenadine hydrochloride 180mg tablets distributed nationwide because stability testing found impurity A exceeded specifications. The affected products are 15-count and 30-count bottles with specific lot numbers and expiration dates.
Perrigo Company is recalling H.E.B Allergy Relief fexofenadine hydrochloride 60mg tablets nationwide due to failure of impurity specifications during stability testing.
Lupin Pharmaceuticals is recalling Oxycodone Hydrochloride Tablets (5 mg) due to out-of-specification impurity test results detected during long-term stability testing. Affected units were distributed in New York and Ohio.
H.E.B Allergy Relief fexofenadine hydrochloride tablets (180mg) are being recalled nationwide due to out-of-specification results for impurity A found during stability testing. The affected product is available in 15, 30, and 45 count bottles.
Perrigo Company PLC is recalling CAREONE Allergy Relief (Fexofenadine HCL) 180 mg tablets nationwide because stability testing found impurity A out of specification.
Amazon-branded Allergy Fexofenadine Hydrochloride Tablets 180 mg are being recalled because testing found an out-of-specification impurity during stability testing.
Perrigo Company PLC is recalling DG/health Aller.Ease Fexofenadine Hydrochloride 180 mg tablets nationwide because they failed impurity specifications during stability testing.
Perrigo Company PLC is recalling Health Mart Fexofenadine Hydrochloride 12HR 60mg tablets due to impurity A exceeding specification limits during stability testing. The recall affects 12,384 containers distributed nationwide.
Perrigo Company PLC is recalling GoodSense Aller.Ease Fexofenadine hydrochloride 180 mg tablets nationwide due to an out-of-specification impurity detected during stability testing.
Perrigo Company PLC is recalling Berkley Jensen Allergy Relief 180 mg fexofenadine tablets due to an impurity specification failure detected during stability testing. The recall affects 7,670 containers distributed nationwide.
Perrigo Company is recalling CVS Allergy Relief Fexofenadine Hydrochloride 180 mg tablets due to an out-of-specification impurity result found during stability testing. The recall affects one lot distributed nationwide.
Biomeme, Inc. is recalling instructions for the SARS-CoV-2 Real Time RT-PCR Test because shelf-life guidance for resuspended RPC Buffer is incorrect. Instructions specify one week stability, but the buffer is only stable for two days at room temperature.
Prepared Meals Co is recalling Happi Foodi Roasted Russets and Asparagus frozen bowls (10 oz) due to the presence of visible mold detected in the product.
Keurig Dr Pepper is recalling Diet Snapple Peach Tea 16 oz bottles with expiration date February 5, 2022, because some units labeled as diet and zero sugar may contain sugar due to a production error.
Meijer allergy relief tablets containing fexofenadine hydrochloride are being recalled nationwide due to out-of-specification impurity results found during stability testing.
Rite Aid Allergy Relief Fexofenadine Hydrochloride 60mg tablets are being recalled due to failed impurity specifications detected during stability testing. The affected product was distributed nationwide.
Amazon Basic+Care Allergy Fexofenadine Hydrochloride Tablets (60 mg, 100-count) are being recalled because impurity levels exceeded acceptable limits during stability testing. The recall affects 38,352 bottles distributed nationwide.
Perrigo Company PLC is recalling TopCare Allergy Relief Fexofenadine Hydrochloride 60mg tablets (12-count bottles, Lot #0LE2178) distributed nationwide due to an out-of-specification impurity result found during stability testing.
Perrigo Company PLC is recalling basic+care allergy Fexofenadine Hydrochloride Tablets, 60 mg, 100-count bottles, due to out-of-specification impurity levels detected during stability testing.
Lupin Pharmaceuticals is recalling Gatifloxacin Ophthalmic Solution 0.5% because water loss test results fell out of specification, which could affect the drug's assay content and concentration.
Perrigo Company is recalling EQUALINE aller-ease fexofenadine hydrochloride tablets, 180 mg, due to impurity A exceeding specification limits during stability testing. The recalled products were distributed nationwide.
Perrigo Company PLC is recalling Wal-Fex Fexofenadine Hydrochloride 180mg tablets distributed nationwide because impurity A levels exceeded specifications during stability testing.
Perrigo Company is recalling allergyrelief Fexofenadine Hydrochloride 24HR tablets due to an out-of-specification result for impurity A detected during stability testing.
Perrigo Company is recalling Kirkland Aller-Fex fexofenadine hydrochloride 180 mg tablets nationwide because stability testing found out-of-specification impurity levels in affected lots.
Perrigo Company PLC is recalling Rite Aid Allergy Relief Fexofenadine Hydrochloride 180mg tablets nationwide due to failed impurity specifications. An out-of-specification result for impurity A was found during stability testing.
Sun Pharmaceutical Industries is recalling Pregabalin 50 mg capsules due to out-of-specification results in particle size distribution and bulk density of the active pharmaceutical ingredient.
Perrigo Company PLC is recalling MAJOR brand Fexofenadine Hydrochloride 12HR 60mg antihistamine tablets due to failed impurities and degradation specifications detected during stability testing.
ULTRAtab Laboratories is recalling Pain Aid ESF bulk tablets due to failed stability test results and inadequate laboratory investigations, which represent deviations from manufacturing standards.
Oshkosh is recalling 2019-2022 S-Series vehicles because front axle u-bolts may fail, potentially allowing the axle to shift or detach and increasing crash risk.
Bella residential elevators pose a risk of child entrapment between exterior and interior doors. Young children can become trapped and suffer serious injuries or death when the elevator moves to another floor.
Savaria and Garaventa residential elevators pose an entrapment risk to young children due to gaps between doors. Young children can become trapped and suffer serious injury or death when the elevator is called to another floor.
Play-Mor is recalling specific 2017-2020 trailers because a propane regulator may fail, increasing pressure and fire risk. Dealers will replace the parts free of charge.
Inclinator Company of America is recalling residential elevators manufactured from 1979 through 2021 because young children can become entrapped between the exterior landing door and interior elevator car door, risking serious injury or death.
Oshkosh is recalling 2019-2022 S-Series vehicles because fuel tubes may crack, causing high-pressure leaks that increase fire risk.
Reading Truck Body is recalling 2017-2021 Marauder Landscape Dump Body vehicles because a rear pivot mount weld may fail, increasing injury risk.
Abbyland Foods is recalling approximately 14,976 pounds of smoked beef sticks because they contain undeclared milk, a known allergen.
Lakota is recalling 2021-2022 Bighorn, Charger, and Livestock trailers because certain tires may experience belt separation, increasing crash risk.
Forest River, Inc. is recalling certain 2021-2022 fifth wheel trailers equipped with defective Sailun tires that may experience belt separation. The defect could cause loss of vehicle control and increase the risk of a crash.
Forest River is recalling 2021-2022 Aurora and Catalina travel trailers because the panel sealing the cooktop from the furnace was not properly sealed, which could cause an inverted flame and fire risk.
Interstate Meat Dist. Inc. is recalling approximately 28,356 pounds of ground beef products due to possible E. coli O157:H7 contamination.
Colony Brands is recalling about 20 covered wood wagons sold through Montgomery Ward's and Ginny's from September to October 2021 because paint on the wood, plastic handles, and red plastic cover contains excessive lead that can be toxic if ingested by young children.
Kettle River Products is recalling approximately 1,464 pounds of chicken alfredo pizza due to misbranding and an undeclared wheat allergen. No adverse reactions have been reported.
Polaris is recalling about 1,100 Model Year 2022 Outlaw 110 EFI Youth ATVs because the inner layer of the fuel line can leak, posing a fire hazard. No fires or injuries have been reported.
Valisa MFG LLC is recalling kleantouch Hand Sanitizer 8 FL OZ pump bottles nationwide because the product contains methanol and was marketed without FDA approval. Consumers should stop using the product immediately.
SterRx is recalling dilTIAZem HCl 125 mg per 125 mL injectable solution nationwide due to lack of assurance of sterility. The recall affects 24,300 bags distributed across the United States.
SterRx is recalling 9,360 bags of Norepinephrine 4 mg per 250 mL injection nationwide due to lack of assurance of sterility. The product is used in hospital and clinical settings to treat low blood pressure.
SterRx is recalling 2,886 bags of Sodium Bicarbonate in 5% Dextrose Injection nationwide due to lack of assurance of sterility. The affected product may pose a risk to patients who receive this intravenous medication.
SterRx is recalling Morphine Sulfate in 0.9% Sodium Chloride Injection (1 mg per mL) nationwide due to lack of assurance of sterility. The recall affects 880 units distributed across the United States.
Gilead Sciences is recalling Veklury (remdesivir) injection vials nationwide due to the presence of glass particulates detected during a customer complaint investigation. The affected lots are 2141001-1A and 2141002-1A with expiration date 01/2024.
SterRx is recalling epinephrine in 0.9% sodium chloride injection (4 mg per 250 mL) nationwide due to lack of assurance of sterility. The recall affects 26,928 bags distributed across the United States.
SterRx is recalling dilTIAZem HCl in 5% Dextrose Injection due to lack of assurance of sterility. The recall affects 8,946 bags distributed nationwide.
SterRx is recalling epinephrine injection (8 mg per 250 mL) due to lack of assurance of sterility. The recall affects 5,832 bags distributed nationwide.
SterRx is recalling approximately 18,948 bags of Phenylephrine HCL in 0.9% Sodium Chloride injection nationwide due to lack of assurance of sterility. The product is distributed across the U.S.A.
SterRx, LLC is recalling Midazolam in 0.9% Sodium Chloride Injection (50 mg per 50 mL) distributed nationwide due to lack of assurance of sterility. The recall affects 15,660 bags from seven lots manufactured between November and December 2021.
Teligent Pharma has recalled 6,816 bottles of Lidocaine Hydrochloride Topical Solution 4% nationwide due to the drug being superpotent. The recall is voluntary and involves Lot #16345 with expiration date 01/2024.
SterRx is recalling Sodium Bicarbonate in 5% Dextrose Injection nationwide due to lack of assurance of sterility. The recall affects 127,260 bags distributed across the U.S.
Frozen Food Development is recalling Giant Eagle brand diced green peppers in multiple package sizes due to positive testing for Listeria monocytogenes. The product was distributed to three accounts in the United States.
SterRx, LLC is recalling 74,508 bags of Norepinephrine 8 mg per 250 mL in 0.9% Sodium Chloride Injection nationwide due to lack of assurance of sterility. The FDA classified this as a Class II recall.
SterRx is recalling 684 bags of epinephrine in 0.9% sodium chloride injection nationwide due to lack of assurance of sterility. The product is supplied to hospitals and healthcare facilities.
Aroma Release Technologies Inc is recalling Klean Touch Hand Sanitizer (Ethyl Alcohol 70%) in 55-gallon drums because the product contains methanol and was marketed without FDA approval as a new drug.
SterRx is recalling 880 bags of Morphine Sulfate in 0.9% Sodium Chloride Injection nationwide due to lack of assurance of sterility. Patients and healthcare providers should stop using affected units immediately.
SterRx is recalling 1,044 bags of Norepinephrine 16 mg per 250 mL in 5% Dextrose Injection nationwide due to lack of assurance of sterility. The affected product carries NDC 70324-002-01 with lot code S21194/CDW.
SterRx is recalling fentanyl citrate injection nationwide due to lack of assurance of sterility. The recall affects approximately 10,660 bags of the product.
SterRx is recalling PHENYLephrine HCl 40 mg per 250 mL injectable solution nationwide due to lack of assurance of sterility. The recall affects approximately 20,640 bags distributed across the United States.
SterRx is recalling 40 bags of Morphine Sulfate in 5% Dextrose Injection (1 mg per mL) distributed nationwide due to lack of assurance of sterility. The product is subject to contamination risk.
SterRx is recalling Fentanyl Citrate in 0.9% Sodium Chloride Injection (2.5 mg per 250 mL) distributed nationwide due to lack of assurance of sterility.
SterRx is recalling Midazolam in 0.9% Sodium Chloride Injection nationwide due to lack of assurance of sterility. The recall affects approximately 36,360 bags distributed across the United States.
SterRx is recalling 121,584 bags of Norepinephrine 4 mg per 250 mL injection nationwide due to lack of assurance of sterility. The drug is used to treat low blood pressure in critical care settings.
SterRx is recalling 1,428 bags of Norepinephrine in 5% Dextrose Injection nationwide due to lack of assurance of sterility. The product is a prescription injectable medication.
SterRx is recalling epinephrine in 0.9% sodium chloride injection (5 mg per 250 mL) nationwide due to lack of assurance of sterility. Affected lots are identified by codes S21255/BXA, S21264/BXH, and S21328/BZO.
SterRx is recalling EPINEPHrine 2 mg per 250 mL injectable solution nationwide due to lack of assurance of sterility. The recall affects 2,779 bags distributed across the U.S.
Siemens Healthcare Diagnostics recalled lot 211446 of the Atellica CH β2-Microglobulin assay due to analytical bias in test results. The assay showed positive bias up to 20.9% at some concentrations and negative bias up to 10.5% at others.
Nationwide recall of VIDAS procalcitonin test kits for substrate defects that prevent testing and require retesting, potentially delaying diagnostic results.
bioMerieux recalled VIDAS Lyme IgG II test devices (two lots) due to a substrate error that prevents tests from running. Users must retest patients, potentially delaying Lyme disease diagnosis.
AMO Manufacturing is recalling Catalys Precision Laser Systems due to a Windows Print Spooler vulnerability that could allow unauthorized remote code execution with system privileges.
bioMerieux is recalling one lot of VIDAS Estradiol II diagnostic test devices due to a substrate error that prevents tests from running, causing delayed results and requiring repeat testing.
CRT Motor is recalling about 100 youth ATVs sold at Motorsports Planet because they do not meet mandatory safety requirements and can exceed maximum speed, increasing crash risk.
Intuitive Surgical recalls 46 da Vinci SP Surgical systems due to software defect causing potential failure or inadvertent delivery of surgical energy. Issue may require surgeon intervention during procedures.
Native Creation is recalling approximately 170 small wool sweaters for children sizes 0 to 8 because the zipper pull contains lead paint that exceeds federal limits and poses a toxic ingestion risk to young children.
AMO Manufacturing's iDesign aberrometer systems (711 units, Models G300 and G301) are vulnerable to remote code execution through the Windows Print Spooler service. An attacker could run arbitrary code with SYSTEM privileges to install programs, access or delete data, or create accounts.
SterRx is recalling 36,576 bags of Norepinephrine 16 mg per 250 mL injection (0.9% Sodium Chloride) distributed nationwide because the manufacturer cannot assure the product meets sterility requirements.
Karl Storz Udel Sterilization Tray instructions for use have been updated to correct sterilization methods and clarify endoscope compatibility. Ethylene oxide is now excluded as a sterilization modality.
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