FDA•LOW
Paragon 28 Navicular Cage Foot Implant
Paragon 28 recalls Navicular Cage foot implant (Model 6123S R) due to elevated oxygen levels.
2 productsFilters
Category
Agency
Severity
Date
Distributed in
All Recalls
Back to home ←
FDA•LOWSyva Emit Tox Tricyclic Antidepressant Calibrator/ControlsSiemens recalls Syva Emit Tox Tricyclic Antidepressant Calibrator/Controls due to out-of-specification sodium azide concentration.
FDA•LOWSyva Emit Disopyramide AssaySiemens recalls Syva Emit Disopyramide Assay due to out-of-spec sodium azide concentration; risk of mild irritation.
FDA•LOWAscend Laboratories: Multiple Dabigatran Etexilate CapsulesAscend recalls Dabigatran Etexilate 75mg/150mg capsules over impurity spec failures.
6 products
FDA•LOWTrokendi XR Topiramate ER Capsules 25mgSupernus recalls Trokendi XR 25mg capsules over failed dissolution specs.
3 products- FDA•LOWAscend Laboratories: Multiple Dabigatran Etexilate Capsules
Ascend recalls Dabigatran etexilate capsules (110 mg, 150 mg) over impurity test failures.
2 products 
FDA•LOWFexofenadine Hydrochloride Tablets 180 mgOhm Laboratories is recalling 180 mg Fexofenadine Hydrochloride tablets due to failed impurities and degradation specifications.
FDA•LOWHydroxyzine Hydrochloride Oral SolutionANI Pharmaceuticals is recalling Hydroxyzine Hydrochloride Oral Solution, 10 mg/5 mL, due to the presence of a foreign substance.
FDA•LOWFocalin XR 5 mg CapsulesSandoz is recalling Focalin XR 5 mg capsules due to missing or incorrect lot numbers and expiration dates on the product labels.
FDA•LOWPrimidone 50 mg TabletsAmneal Pharmaceuticals is recalling Primidone 50 mg tablets due to potential cross-contamination with Acemetacin API.
FDA•LOWEpinephrine Injection 1mg/mLFresenius Kabi is recalling Epinephrine Injection 1mg/mL vials due to out-of-specification stability test results.
FDA•LOWYunker Energy & Health Herbal SupplementSato Pharmaceutical is recalling Yunker Energy & Health Herbal Supplement due to a failure to meet label claims for Vitamin E content.
FDA•LOWLidocaine HCl Injection 2%Eugia US LLC is recalling Lidocaine HCl Injection 2% because the label wrap covers the barcode, making it difficult to scan.
FDA•LOWPred Mild Ophthalmic SuspensionAbbVie is recalling 10 mL bottles of Pred Mild ophthalmic suspension due to failed stability specifications.
FDA•LOWNicotine Transdermal System Patch 14 mgAveva is recalling 14 mg Nicotine Transdermal System Patches due to elevated levels of oxidative-related impurities.
FDA•LOWPrimidone Tablets 250 mgAmerican Health Packaging recalls Primidone Tablets 250 mg due to trace Acemetacin contamination.
2 products
FDA•LOWBusulfan InjectionSagent Pharmaceuticals is recalling Busulfan Injection (NDC 25021-241-10) due to failed impurities and degradation specifications.
FDA•LOWPrimidone Tablets 50 mgPrimidone 50 mg tablets recalled due to possible cross-contamination with Acemetacin.
2 products
FDA•LOWPrimidone 250mg TabletsLannett Company is recalling Primidone 250mg Tablets (NDC 0527-1231-01) due to potential cross-contamination with Acemetacin API.
FDA•LOWBuspirone Hydrochloride TabletsUnichem is recalling 5 mg buspirone hydrochloride tablets due to subpotency, which may reduce the medication's effectiveness.
FDA•LOWCVS Lidocaine Wound GelCVS is recalling Lidocaine Wound Gel (NDC 59898-950, 0.5 oz) due to failed pH specifications.
FDA•LOWPALAMIX uno Mixing UnitHeraeus recalls PALAMIX uno mixing units: mixing rod may loosen in units over 17 months old; shelf life reduced to 1.5 years.
2 products
FDA•LOWLevocarnitine Injection, USPAmerican Regent is recalling Levocarnitine Injection, USP, 1 g/5 mL single-dose vials due to missing labels.
FDA•LOWMonsel's Ferric Subsulfate Solution 8 mLPremier Dental Products is recalling Monsel's Ferric Subsulfate Solution 8 mL vials (NDC 48783-112-08) due to incorrect expiration date on the vial label.
FDA•LOWMagnesium Chloride 6-Hydrate Crystal 500GAvantor is recalling Magnesium Chloride 6-Hydrate Crystal 500G bottles (NDC 10106-2448-1) due to subpotency.
FDA•LOWIsland Kinetics: multiple gelsIsland Kinetics recalls hydrocortisone 1% gels (Remedy Gel, Skin Rehab, Essential Calming) due to subpotency.
3 products
FDA•LOWSodium Iodide I-131 Kit Gelatin Capsule PackRadnostix is recalling Sodium Iodide I-131 Kit capsule packs due to failed product specifications.
FDA•LOWDatascope Cardiosave Battery Charging StationDatascope is recalling the Cardiosave battery charging station due to a screw defect in the left bay that prevents proper charging.
FDA•LOWC2O Coconut Water with Pulp 17.5 ozC2O Coconut Water with Pulp 17.5 oz recalled over incorrect outer box labeling omitting added sugar.
FDA•LOWCipla: Multiple Packaged In Cartons CapsulesCipla recalls Nilotinib 150 mg and 200 mg capsules over failed specification tests.
2 products
FDA•LOWEptifibatide Injection 75 mg/100 mLSlate Run Pharmaceuticals recalls Eptifibatide Injection 75 mg/100 mL vials (NDC 70436-027-80, 70436-163-80) due to incorrect dosing-route labeling.
FDA•LOWSodexo Stars Saccharin PacketsDomino Foods recalls Sodexo Stars Saccharin Packets due to undeclared aspartame.
FDA•LOWDoxazosin Tablets, USP 4 mgUnichem is recalling Doxazosin Tablets 4 mg (NDC 29300-353-10) due to incorrect tablet imprinting that may cause medication errors.
FDA•LOWStraumann WB Impression Post Closed TrayStraumann is recalling WB Impression Post Closed Tray kits (L 13mm) due to incorrect magenta impression caps instead of brown.