FDA•MODERATE
Paxil CR Paroxetine 37.5mg Tablets
Apotex recalls Paxil CR 37.5mg tablets for failing dissolution specs.
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Drugs Recalls
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FDA•MODERATERamipril Capsules USP 10 mgHikma recalls Ramipril Capsules USP 10 mg over a failed impurity (DCU) specification.
FDA•MODERATEZicam Medicated Nasal SwabsZicam nasal swabs recalled over microbiological testing failures.
FDA•MODERATEActhar Gel (Repository Corticotropin Injection) 5 mL VialsMallinckrodt recalls Acthar Gel 5 mL vials over glass and stopper particulate.
2 products
FDA•MODERATEClobetasol Propionate Cream USP, 0.05%Lupin recalls Clobetasol Propionate Cream 0.05% due to failed content uniformity.
FDA•MODERATELevothyroxine Sodium Tablets 25 mcgAccord recalls Levothyroxine 25 mcg tablets due to subpotency.
12 products
FDA•MODERATECarbamazepine Tablets 200mgGSMS recalls Carbamazepine 200mg tablets over black specks.
FDA•MODERATEAcamprosate Calcium 333 mg TabletsMylan recalls Acamprosate Calcium 333 mg tablets over dissolution failure.
FDA•MODERATECarbamazepine Tablets 200mgTaro recalls Carbamazepine 200mg tablets over black specks.
2 products
FDA•MODERATEPEMRYDI RTU Pemetrexed InjectionShilpa Medicare recalls PEMRYDI RTU vials over green discoloration.
2 products
FDA•MODERATELibtayo (cemiplimab-rwlc) InjectionRegeneron recalls Libtayo (cemiplimab-rwlc) Injection 350 mg/7 mL over sterility concerns.
FDA•MODERATEShoolin Pharma Chem: multiple drugsShoolin Pharma Chem recalls Sildenafil and Tadalafil APIs due to CGMP deviations.
5 products
FDA•MODERATEClear Eyes Maximum Itchy Eye ReliefClear Eyes Maximum Itchy Eye Relief recalled over potential sterility issues.
FDA•MODERATEClindamycin Palmitate Hydrochloride Oral SolutionAvet recalls Clindamycin Palmitate Oral Solution 75 mg/5 mL over particles and white flakes.
FDA•MODERATEDiovan (valsartan) 160 mg TabletsNovartis recalls Diovan (valsartan) 160 mg tablets due to failed dissolution specs.
FDA•MODERATESemaglutide 12.5mg Multi-Dose VialApollo Care recalls semaglutide 12.5mg vials due to particulate matter.
11 products
FDA•MODERATEMirabegron Extended-Release Tablets 25 mgZydus recalls Mirabegron ER 25 mg tablets over nitrosamine impurity.
FDA•MODERATEDicyclomine Hydrochloride Capsules 10mgAurobindo recalls Dicyclomine HCl 10mg capsules due to shortfill and empty capsules.
FDA•MODERATEAzelaic Acid Gel 15%Glenmark recalls Azelaic Acid Gel 15% over grainy/gritty texture complaints.
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•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•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•MODERATEDivalproex Sodium Delayed-Release Tablets 500 mgBionpharma recalls Divalproex Sodium 500 mg tablets due to foreign tablets/capsules.
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•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•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•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•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•MODERATEPovi-One 10% Povidone-Iodine Oral AntisepticElevate Oral Care is recalling Povi-One 10% Povidone-Iodine Oral Antiseptic due to sub-potency.
FDA•MODERATEPerampanel CIII TabletsSun Pharmaceutical is recalling 6mg Perampanel CIII tablets due to a labeling mix-up where bottles may contain 10mg tablets.
FDA•MODERATELacosamide 100mg TabletsCamber Pharmaceuticals is recalling Lacosamide 100mg tablets due to a potential mix-up with Selexipag 1000 mcg tablets.
2 products
FDA•MODERATEPReye Vitamin See Antioxidant Eye DropsPReye is recalling Vitamin See Antioxidant Preservative Free Eye Drops due to a lack of assurance of sterility.
FDA•MODERATEDuloxetine Delayed-Release CapsulesDirect Rx is recalling 30 mg Duloxetine Delayed-Release capsules due to N-nitroso-duloxetine impurity levels exceeding FDA limits.