FDA•MODERATE
Dicyclomine Hydrochloride Capsules 10mg
Aurobindo recalls Dicyclomine HCl 10mg capsules due to shortfill and empty capsules.
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Drugs Recalls
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FDA•MODERATEAmerican Regent: multiple injectionsAmerican Regent recalls Adequan injections due to particulate matter including glass.
2 products
FDA•CRITICALOptiray 350 Ioversol InjectionLiebel-Flarsheim recalls Optiray 350 Ioversol Injection 500 mL vials due to particulate matter (plastic, steel, glass).
2 products
FDA•MODERATEAzelaic Acid Gel 15%Glenmark recalls Azelaic Acid Gel 15% over grainy/gritty texture complaints.
FDA•CRITICALRelax 5-HTP Plus Vitamin B6Relax 5-HTP Plus Vitamin B6 recalled for elevated 5-HTP levels above allowed dosage.
2 products
FDA•CRITICALCefazolin in Dextrose InjectionBaxter recalls Cefazolin in Dextrose 2g/100mL infusion bags due to particulate matter.
FDA•CRITICALAmerican Regent: Multiple Packaged In InjectionsAmerican Regent recalls Nitroglycerin Injection 50 mg/10 mL and other injectables due to particulate matter (hair).
14 products
FDA•MODERATEDorzolamide HCl and Timolol Maleate Ophthalmic SolutionMicro Labs recalls Dorzolamide HCl/Timolol Maleate 2%/0.5% 10mL ophthalmic solution due to defective container caps.
FDA•MODERATEProin ER TabletsPegasus recalls Proin ER 145 mg dog tablets over failed dissolution specs.
FDA•LOWAscend Laboratories: Multiple Dabigatran Etexilate CapsulesAscend recalls Dabigatran Etexilate 75mg/150mg capsules over impurity spec failures.
6 products
FDA•MODERATEMycophenolate Mofetil for InjectionMylan recalls Mycophenolate Mofetil for Injection 500 mg/vial due to precipitate.
2 products
FDA•MODERATEFresenius Kabi: Multiple Rx Only InjectionsFresenius Kabi recalls injectables due to hair particulate matter.
5 products
FDA•MODERATERohto-Mentholatum: Multiple Rohto Cooling Eye DropsRohto Cooling Eye Drops recalled over sterility concerns; multiple formulations affected.
8 products
FDA•MODERATEGlycopyrrolate Oral Solution 1 mg/5 mLPrecision Dose recalls Glycopyrrolate Oral Solution 1 mg/5 mL over an impurity.
3 products
FDA•MODERATEAXP Processing Bag SetThermoGenesis recalls AXP Processing Bag Set, Model 8-5101, over stopcock particulates in sterile fluid path.
FDA•LOWLidolog KitLidolog Kit is being recalled because the label wrap obscures the barcode, making it difficult to scan.
2 products
FDA•CRITICALCetirizine Hydrochloride Tablets 5 mgRising Pharma recalls Cetirizine HCl 5 mg tablets due to ranitidine cross-contamination.
FDA•MODERATECyproheptadine Hydrochloride SyrupRising Pharma recalls Cyproheptadine HCl Syrup 2mg/5 mL due to crystallization and floating particles.
FDA•MODERATELevothyroxine Sodium Tablets 25 mcgMajor Pharmaceuticals recalls Levothyroxine 25 mcg tablets due to subpotency.
12 products
FDA•MODERATEAmlodipine and Olmesartan Medoxomil TabletsAscend Laboratories is recalling Amlodipine and Olmesartan Medoxomil Tablets (10 mg/20 mg) due to failed dissolution specifications.
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•MODERATEDivalproex Sodium Delayed-Release Tablets 500 mgBionpharma recalls Divalproex Sodium 500 mg tablets due to foreign tablets/capsules.
FDA•MODERATEApheresis Platelets, Leukocytes Reduced, IrradiatedLifeSouth is recalling Apheresis Platelets, Leukocytes Reduced, Irradiated, due to failure to meet platelet yield specifications.
FDA•MODERATEBD ChloraPrep Clear ApplicatorsCareFusion is recalling BD ChloraPrep Clear sterile solution applicators due to a potential lack of sterility from incomplete packaging seals.
FDA•MODERATECleviprex Injectable EmulsionChiesi USA is recalling Cleviprex (clevidipine injectable emulsion) 50 mg/100 mL vials due to a lack of assurance of sterility.
FDA•MODERATEBell Pharmaceuticals: Multiple Carbamide Peroxide ProductsBell Pharmaceuticals recalls carbamide peroxide 6.5% earwax removers (CVS Health, Clinere, TopCare, etc.) for subpotency.
11 products
FDA•MODERATENystatin Cream USPPadagis is recalling 15 g tubes of Nystatin Cream USP due to subpotent drug results found during stability testing.
FDA•MODERATEPemetrexed for Injection 100mg/VialSomerset Therapeutics recalls Pemetrexed for Injection 100mg/Vial due to cGMP deviations.
4 products
FDA•MODERATEGasco Industrial: Multiple Isopropyl Alcohol ProductsGasco recalls Isopropyl Alcohol 70% in multiple sizes due to subpotency, which may reduce antiseptic effectiveness.
6 products- FDA•MODERATEApheresis Platelets, Leukocytes Reduced, Irradiated
Vitalant is recalling Apheresis Platelets, Leukocytes Reduced, Irradiated due to missing white blood cell count verification testing.
FDA•MODERATEMethohexital Sodium 100 mg/10 mLQuVa Pharma is recalling Methohexital Sodium 100 mg/10 mL vials due to failed impurities and degradation specifications.
FDA•MODERATEMedline Remedy Specialized Silicone CreamMedline Remedy Specialized Silicone Cream is recalled due to an out-of-specification result for formaldehyde in the raw material.
FDA•MODERATEClomiphene Citrate USP Active Pharmaceutical IngredientShimoga Chemicals is recalling Clomiphene Citrate USP Active Pharmaceutical Ingredient due to cGMP deviations.
FDA•MODERATEMethohexital Sodium for Injection 500 mgAvet Pharmaceuticals is recalling Methohexital Sodium for Injection 500 mg vials due to failed impurities and degradation specifications.
FDA•MODERATECinacalcet Hydrochloride Tablets 30 mgCipla recalls Cinacalcet HCl 30 mg tablets due to nitrosamine impurity above ADI.
3 products
FDA•MODERATEDextroamphetamine/Amphetamine Extended-Release CapsulesLannett is recalling 5 mg Dextroamphetamine/Amphetamine ER capsules due to a labeling mix-up where capsules contain immediate-release pellets.
FDA•MODERATEAsclemed: Multiple Lidocaine Hcl InjectionsAsclemed recalls Accucaine kits and Lidocaine HCl Injection USP, 1% (10 mg/mL), 5 mL ampules due to lack of sterility assurance.
2 products
FDA•MODERATEGlucagon Emergency KitLupin recalls Glucagon Emergency Kits due to a stability test failure that may impair emergency use.
3 products
FDA•MODERATEGemcitabine InjectionHikma is recalling Gemcitabine Injection due to improper temperature storage.
FDA•MODERATESynjardy XR TabletsBoehringer Ingelheim is recalling Synjardy XR tablets due to manufacturing deviations involving improper cleaning and sampling of production equipment.
FDA•MODERATELevothyroxine Sodium Tablets 300 mcgAccord Healthcare is recalling 300 mcg Levothyroxine Sodium Tablets due to subpotency.
FDA•MODERATEprednisoLONE Acetate Ophthalmic Suspension 1%Lupin Pharmaceuticals is recalling three sizes of prednisoLONE Acetate Ophthalmic Suspension 1% due to the presence of a foreign substance.
FDA•LOWFexofenadine Hydrochloride Tablets 180 mgOhm Laboratories is recalling 180 mg Fexofenadine Hydrochloride tablets due to failed impurities and degradation specifications.
FDA•MODERATEImuldosa (ustekinumab-srlf) InjectionAccord BioPharma is recalling Imuldosa (ustekinumab-srlf) 130 mg/26 mL injection vials due to a lack of assurance of sterility.
FDA•CRITICALTNVitamins Organic Moringa Capsules and PowderTNVitamins Organic Moringa Capsules and Powder recalled due to possible Salmonella contamination.
FDA•CRITICALDiclofenac Sodium 0.1% Eye OintmentMFV Compounding Pharmacy is recalling Diclofenac Sodium 0.1% Eye Ointment due to potential Bacillus cereus contamination.
FDA•MODERATEPovi-One 10% Povidone-Iodine Oral AntisepticElevate Oral Care is recalling Povi-One 10% Povidone-Iodine Oral Antiseptic due to sub-potency.
FDA•MODERATEPediatric Total Parenteral Nutrition BagCentral Admixture Pharmacy Services is recalling a pediatric TPN bag due to an incorrect formulation missing copper and famotidine.
FDA•MODERATEPerampanel CIII TabletsSun Pharmaceutical is recalling 6mg Perampanel CIII tablets due to a labeling mix-up where bottles may contain 10mg tablets.