FDA•MODERATE
Duloxetine Delayed-Release Capsules
Direct Rx is recalling 30 mg Duloxetine Delayed-Release capsules due to N-nitroso-duloxetine impurity levels exceeding FDA limits.
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FDA•MODERATEAmgen Corlanor and Sensipar TabletsAmgen recalls Corlanor and Sensipar tablets over foreign substance contamination.
5 products
FDA•MODERATEMethylergonovine Maleate TabletsMajor Pharmaceuticals is recalling 0.2 mg Methylergonovine Maleate Tablets due to subpotency.
FDA•MODERATEFenofibrate Capsules, USP 200 mgAjanta Pharma is recalling Fenofibrate Capsules, USP 200 mg, due to manufacturing process deviations.
FDA•MODERATEKeystone Industries: Multiple Topical Anesthetic GelsKeystone recalls 20% benzocaine gels (Pearson, Quala, DHP, etc.) over defective seals.
7 products
FDA•MODERATEBuprenorphine HCl InjectionPar Health is recalling Buprenorphine HCl Injection due to crystallization identified as Buprenorphine free base.
FDA•MODERATEAripiprazole 30 mg TabletsAjanta Pharma is recalling Aripiprazole 30 mg tablets due to a mix-up with Voriconazole 50 mg tablets.
FDA•MODERATEDabur India: Multiple Made In India ProductsDabur India recalls 14 OTC topical products over CGMP deviations.
14 products
FDA•MODERATEChlorthalidone 25 mg TabletsChlorthalidone 25 mg tablets are being recalled due to failed dissolution specifications.
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•MODERATEAlyacen 7/7/7 TabletsGlenmark is recalling Alyacen 7/7/7 tablets due to out-of-specification results for total impurities.
FDA•MODERATEVasopressin 2 Units/2 mL SyringesIntegraDose is recalling Vasopressin 2 Units/2 mL syringes due to subpotency, which may cause the drug to be ineffective.
FDA•MODERATEPAI: Multiple Kerr Insta-char In An ProductsVistaPharm recalls Kerr Insta-Char activated charcoal (25g/50g) for failing OTC monograph requirements.
4 products
FDA•MODERATENiacin Extended-Release Tablets 1,000 mgGolden State Medical Supply is recalling Niacin Extended-Release Tablets, 1,000 mg, due to failure to meet dissolution specifications.
2 products
FDA•LOWPrimidone 50 mg TabletsAmneal Pharmaceuticals is recalling Primidone 50 mg tablets due to potential cross-contamination with Acemetacin API.
FDA•MODERATEMinocycline Hydrochloride 115 mg TabletsAscend Laboratories is recalling Minocycline Hydrochloride 115 mg tablets due to failed dissolution specifications.
FDA•MODERATEZep Alcohol Sanitizer SprayZep Inc. is recalling 55-gallon containers of Alcohol Sanitizer Spray due to potential microbial contamination.
FDA•MODERATEBudesonide Inhalation SuspensionSun Pharmaceutical is recalling Budesonide Inhalation Suspension (1mg/2mL) due to the presence of foreign black or brown particles.
FDA•MODERATEBreckenridge Pharmaceutical: multiple capsulesBreckenridge recalls Duloxetine 30mg and 60mg capsules due to N-nitroso-duloxetine impurity above FDA limit.
2 products
FDA•MODERATECareFusion 213: Multiple Subsidiary Of Beckton SolutionsBD recalls ChloraPrep & PurPrep applicators due to lack of sterility assurance, posing infection risk.
10 products
FDA•LOWEpinephrine Injection 1mg/mLFresenius Kabi is recalling Epinephrine Injection 1mg/mL vials due to out-of-specification stability test results.
FDA•MODERATENiacin Extended-release Tablets 1,000 mgLannett is recalling Niacin Extended-release Tablets 1,000 mg due to failed dissolution specifications.
FDA•MODERATEKirkland Signature Ultra Strength AntacidKirkland Signature antacid recalled due to metallic particles in tablets.
23 products
FDA•MODERATEXyvona (levorphanol tartrate) 2mg TabletsForte BioPharma recalls Xyvona (levorphanol tartrate) 2mg tablets due to FDA denial of proprietary name.
2 products
FDA•MODERATELidocaine HCl Injection USPSpectra Medical Devices is recalling Lidocaine HCl Injection USP single-dose ampules due to a lack of assurance of sterility.
FDA•MODERATEAmlodipine and Olmesartan Medoxomil TabletsAscend Laboratories is recalling Amlodipine and Olmesartan Medoxomil Tablets, 5mg/40mg, due to failed dissolution specifications.
FDA•MODERATEDuloxetine DR Capsules 30 mgAsclemed USA is recalling Duloxetine DR Capsules 30 mg due to the presence of a nitrosamine impurity above acceptable intake limits.
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•MODERATEToxiBan Charcoal-Kaolin SuspensionLloyd is recalling ToxiBan Charcoal-Kaolin Suspension for domestic animals due to microbial levels exceeding specification limits.
FDA•MODERATEFentanyl Citrate Sterile CADD for InjectionIntegraDose is recalling Fentanyl Citrate Sterile CADD for Injection (NDC 71139-6030-1) due to the product being subpotent.
FDA•MODERATENephronex Vitamin B-Complex, Vitamin C & Folic Acid LiquidSafecor Health is recalling Nephronex dietary supplement liquid due to the presence of foreign black particles.
FDA•MODERATEEstradiol Gel 0.1%ANI Pharmaceuticals is recalling Estradiol Gel 0.1% due to defective packets that may be empty or partially full.
FDA•MODERATECimzia Prefilled SyringesUCB is recalling Cimzia prefilled syringes and starter kits due to a lack of assurance of sterility.
FDA•MODERATEErythromycin Tablets 250 mgZydus recalls Erythromycin 250 mg tablets due to impurity above acceptable limit.
2 products
FDA•MODERATEGas-X Simethicone 125 mg SoftGelsHaleon is recalling Gas-X Simethicone 125 mg SoftGels (120 count), UPC 3 00674 35041 9, due to incomplete inactive ingredient labeling.
FDA•MODERATELiraglutide InjectionLupin is recalling Liraglutide Injection (NDC 70748-346-02 and 70748-346-03) due to white thread-like particulate matter in the cartridge.
FDA•MODERATEAtomoxetine HCl CapsulesSafecor Health is recalling Atomoxetine HCl capsules due to a labeling mix-up that may result in patients receiving an incorrect dosage.
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•MODERATEOphthavet Ophthalmic SolutionDechra is recalling Ophthavet Ophthalmic Solution for dogs and cats due to a lack of sterility assurance.
FDA•MODERATEMetoprolol Succinate Extended-Release Tablets 25 mgAscend Laboratories is recalling 25 mg Metoprolol Succinate Extended-Release Tablets due to failed dissolution testing.
FDA•MODERATEBuprenorphine Hydrochloride Injection 0.3mg/mLEndo USA recalls Buprenorphine Hydrochloride Injection 0.3mg/mL vials (NDC 42023-179-05) due to particulate matter contamination.
FDA•MODERATEOasis Tears PF Lubricant Eye DropsOasis Tears PF eye drops (NDC 42126-6400-1) recalled due to lack of assurance of sterility.
FDA•MODERATEDuloxetine Delayed-Release Capsules 60mgBreckenridge Pharmaceutical is recalling Duloxetine 60mg capsules distributed nationwide due to the presence of an impurity above FDA limits.
FDA•MODERATENaproxen Oral SuspensionAcella Pharmaceuticals is recalling Naproxen Oral Suspension, 125 mg/5mL, distributed nationwide due to lead and lithium contamination.
FDA•MODERATEAmoxicillin and Clavulanate Potassium Oral Suspension DropsCronus Pharma is recalling Amoxicillin and Clavulanate Potassium oral suspension drops for dogs and cats due to product discoloration.
2 products