FDA•MODERATE
Buprenorphine Hydrochloride Injection 0.3mg/mL
Endo USA recalls Buprenorphine Hydrochloride Injection 0.3mg/mL vials (NDC 42023-179-05) due to particulate matter contamination.
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Drugs Recalls
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FDA•MG217 Multi-symptom Treatment CreamPharmacal is recalling 6oz tubes of MG217 Multi-symptom Treatment Cream 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 PD solution 2L 5PK over potential sterility-compromising leaks.
2 products
FDA•MODERATEDuloxetine Delayed-Release Capsules 30 mgAjanta Pharma recalls Duloxetine 30 mg capsules due to N-nitroso-Duloxetine impurity above FDA limit.
3 products
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•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•MODERATEFreshKote Lubricant EyedropsHarrow Eye LLC is recalling FreshKote Lubricant Eyedrops (0.33 fl oz) due to lack of assurance of sterility.
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•MODERATEiVIZIA Sterile Lubricant Eye DropsThea Pharma is recalling iVIZIA Sterile Lubricant Eye Drops due to a lack of assurance of sterility.
2 products
FDA•LOWLevocarnitine Injection, USPAmerican Regent is recalling Levocarnitine Injection, USP, 1 g/5 mL single-dose vials due to missing labels.
FDA•MODERATEWells Pharma of Houston: multiple drugsWells Pharma recalls injectable solutions (phenylephrine, fentanyl, ketamine) over cGMP deviations.
7 products
FDA•MODERATEAlcon Research: Multiple Lubricant Eye Gel ProductsAlcon 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•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•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 mL BagsB. Braun recalls Sterile Water for Injection 3000 mL bags over sterility concerns from potential port leakage.
4 products
FDA•MODERATESkin Script Blemish Spot TreatmentSkin Script Blemish Spot Treatment recalled over failed stability specifications; UPC 6 10563 13873 9.
FDA•LOWMagnesium Chloride 6-Hydrate Crystal 500GAvantor is recalling Magnesium Chloride 6-Hydrate Crystal 500G bottles (NDC 10106-2448-1) due to subpotency.
FDA•LOWAmprol 25% Medicated ArticleHuvepharma is recalling one bag of Amprol 25% medicated article due to missing lot number and expiration date information.
FDA•MODERATEFurosemide Tablets, USP 80 mgLeading Pharma is recalling Furosemide Tablets 80 mg (NDC 69315-118-01) due to N-nitroso-Furosemide above recommended limits.
FDA•MODERATEClaravis (isotretinoin capsule, USP) 10 mgTeva is recalling Claravis 10 mg capsules (NDC 0555-1054-56, 0555-1054-86) due to out-of-specification Tretinoin impurity levels.
3 products
FDA•MODERATEMemantine Hydrochloride Extended-Release CapsulesMajor Pharmaceuticals is recalling 7 mg Memantine Hydrochloride Extended-Release Capsules due to failed dissolution specifications.
FDA•MODERATEPantoprazole Sodium Delayed-Release Tablets 40 mgCamber Pharmaceuticals is recalling Pantoprazole Sodium 40 mg tablets (NDC 31722-713-10) due to discoloration.
FDA•MODERATEDesmopressin Nasal Spray, USP 10 mcg/0.1 mLApotex is recalling Desmopressin Nasal Spray (NDC 60505-0815-0) due to defective bottle caps with missing or dislodged liners.
3 products
FDA•MODERATEEpinephrine Injection USP 1 mg/10mLInternational Medication Systems is recalling Epinephrine Injection 1 mg/10mL (NDC 76329-3318-1) due to lack of sterility assurance.
FDA•MODERATEClonidine Transdermal System 0.2 mg/dayTeva recalls Clonidine Transdermal System 0.2 mg/day over CGMP deviations from unapproved raw material.
3 products
FDA•MODERATEHuons Co: Multiple Rx Only ProductsHuons recalls Lidocaine HCl 1% vials and other injectables over sterility concerns.
9 products
FDA•LOWIsland Kinetics: multiple drugsIsland Kinetics recalls three hydrocortisone 1% gels due to subpotency.
3 products
FDA•MODERATEAlbuterol Sulfate Inhalation Solution 0.5%Nephron SC recalling Albuterol Sulfate Inhalation Solution (NDC 69374-330-05) due to illegible labeling.
FDA•MODERATEFluocinonide Cream 0.05%Taro recalls Fluocinonide Cream 0.05% 15g tubes due to failed viscosity specs.
3 products
FDA•MODERATESemaglutide-Glycine-Cyanocobalamin InjectableNorthwest Compounders is recalling Semaglutide-Glycine-Cyanocobalamin Injectable vials due to lack of assurance of sterility.
FDA•MODERATEFarmHouse Fresh Midnight Clearing Night LotionFarmHouse Fresh Night Lotion recalled due to benzene contamination.
4 products
FDA•MODERATECinacalcet Hydrochloride TabletsCipla recalls Cinacalcet HCl tablets over CGMP deviations and nitrosamine impurity.
3 products
FDA•MODERATEMenthol Cough Drops Honey LemonMGC Health recalls Honey Lemon cough drops over quality concerns from FDA inspection.
15 products
FDA•MODERATELanreotide Injection 120 mg/0.5 mLCipla recalls Lanreotide Injection 120 mg/0.5 mL over sterility assurance concerns.
2 products
FDA•MODERATEOmnipaque (iohexol) Injection 350 mg/mLGE Healthcare recalls Omnipaque 350 mg/mL injection due to particulate matter.
2 products
FDA•CRITICALBlaine Labs: multiple drugsBlaine Labs recalls Revitaderm Wound Care Gel and other products over microbial contamination.
9 products
FDA•CRITICALMagnesium Sulfate in Water for Injection IV BagAmneal is recalling Magnesium Sulfate IV bags (NDC 70121-1720-3) due to product mix-up with Tranexamic Acid.
FDA•MODERATEXanax XR Alprazolam 3 mg TabletsViatris is recalling Xanax XR 3 mg tablets (NDC 58151-506-91) due to failed dissolution specifications.
FDA•MODERATEIsotretinoin Capsules, USP, 40 mgTeva is recalling 40 mg Isotretinoin Capsules due to potency issues.
2 products
FDA•MODERATEVancomycin HCl InjectionFagron recalls Vancomycin HCl 1.5g/250mL injection over sterility concerns; port part may detach.
5 products