FDA•MODERATE
PAI: Multiple Kerr Insta-char In An Products
VistaPharm recalls Kerr Insta-Char activated charcoal (25g/50g) for failing OTC monograph requirements.
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Drugs Recalls
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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•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•CRITICALBeekeeper's Naturals Saline Nasal SprayBeekeeper's Naturals recalls Saline Nasal Spray due to microbial contamination.
2 products
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•CRITICALCareFusion 213: Multiple Chlorhexidine Gluconate SolutionsBD recalls ChloraPrep Clear and FREPP Clear applicators due to sterility seal breach risk.
4 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•CRITICALHaleon US: multiple softgelsHaleon recalls Gas-X Extra Strength softgels (120 & 72 ct) over possible coolant contamination.
2 products
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•CRITICALMogo Pure Moringa Oleifera CapsulesMogo Moringa is recalling Pure Moringa Oleifera Capsules due to potential Salmonella Typhimurium contamination.
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•MODERATEOphthavet Ophthalmic SolutionDechra is recalling Ophthavet Ophthalmic Solution for dogs and cats due to a lack of sterility assurance.
FDA•CRITICALDOXOrubicin Hydrochloride Liposome InjectionSun Pharma recalls DOXOrubicin Liposome Injection 50 mg/25 mL vials due to glass particulate matter.
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•CRITICALMG217 Multi-Symptom Treatment CreamMG217 Multi-Symptom Treatment Cream recalled due to Staphylococcus aureus 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
FDA•MODERATEOctreotide Acetate for Injectable SuspensionTeva is recalling Octreotide Acetate 30 mg injection kits due to a lack of assurance of sterility.
2 products
FDA•MODERATEEnalapril Maleate Tablets, USP 20 mgRising Pharma is recalling Enalapril Maleate 20 mg tablets (NDC 64980-688-10) due to failed impurities test.
FDA•MODERATEBD PurPrep Sterile SolutionCareFusion is recalling BD PurPrep sterile solution due to a lack of assurance of sterility and potential product contamination.
2 products
FDA•MODERATEDELFLEX Peritoneal Dialysis SolutionFresenius recalls DELFLEX dialysis solution due to potential bag leaks compromising sterility.
2 products
FDA•MODERATEDuloxetine Delayed-Release Capsules 30 mgAjanta recalls Duloxetine 30 mg capsules over nitrosamine impurity above FDA limit.
3 products
FDA•MODERATEAlendronate Sodium Oral Solution 70 mg/75 mLHikma is recalling Alendronate Sodium Oral Solution 70 mg/75 mL (NDC 0054-0282-59) due to out-of-specification assay results.
FDA•CRITICALLactated Ringer's Injection USPB. Braun Medical is recalling Lactated Ringer's Injection USP due to the presence of particulate matter.
FDA•MODERATEOptase Dry Eye Intense DropsScope Health is recalling Optase Dry Eye Intense Drops (0.33 fl oz, NDC 72972-002-01) due to lack of assurance of sterility.
FDA•MODERATEThea Pharma: Multiple Sterile Lubricant Eye DropsThea Pharma recalls iVIZIA Sterile Lubricant Eye Drops (Povidone 0.5%) over sterility concerns from CGMP deviations.
2 products
FDA•MODERATEWells Pharma of Houston: multiple injectionsWells Pharma recalls injectable drugs (phenylephrine, fentanyl, ketamine) over cGMP deviations.
7 products
FDA•MODERATEAlcon Research: Multiple Lubricant Eye GelsAlcon recalls Systane and GenTeal eye gels over sterility concerns.
2 products
FDA•MODERATEOmega-3-Acid Ethyl Esters CapsulesMajor Pharmaceuticals is recalling Omega-3-Acid Ethyl Esters Capsules due to failed stability testing for capsule shell loss on drying.
FDA•CRITICALHeritage Animal Nutrition Medicated FeedHeritage Animal Nutrition is recalling 50 lb bags of medicated feed due to potential rumensin contamination.
FDA•MODERATEB. Braun Sterile Water for Injection 3000 mLB. Braun recalls Sterile Water for Injection 3000 mL bags over sterility and leakage risk.
4 products
FDA•MODERATEFreshKote Lubricant EyedropsHarrow Eye LLC is recalling FreshKote Lubricant Eyedrops (0.33 fl oz) due to lack of assurance of sterility.