FDA•MODERATE
Epinephrine Injection USP 1 mg/10mL
International Medication Systems is recalling Epinephrine Injection 1 mg/10mL (NDC 76329-3318-1) due to lack of sterility assurance.
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FDA•MODERATEClonidine Transdermal System 0.2 mg/dayTeva recalls Clonidine Transdermal System 0.2 mg/day due to CGMP deviations (unapproved raw material).
3 products
FDA•MODERATEHuons: Multiple Rx Only InjectionsHuons recalls injectable lidocaine, bupivacaine, and saline due to sterility concerns.
9 products
FDA•LOWIsland Kinetics: multiple gelsIsland Kinetics recalls hydrocortisone 1% gels (Remedy Gel, Skin Rehab, Essential Calming) 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 0.05% Cream 15gTaro recalls Fluocinonide 0.05% Cream 15g tubes due to out-of-spec viscosity.
3 products
FDA•MODERATESemaglutide-Glycine-Cyanocobalamin InjectableNorthwest Compounders is recalling Semaglutide-Glycine-Cyanocobalamin Injectable vials due to lack of assurance of sterility.
FDA•MODERATEHydroPeptide Clear Alliance SerumHydroPeptide Clear Alliance Serum recalled due to benzene contamination.
4 products
FDA•MODERATECinacalcet Hydrochloride Tablets 30 mgCipla recalls Cinacalcet HCl 30 mg tablets over N-Nitroso impurity above acceptable limit.
3 products
FDA•MODERATEExchange Select Honey Lemon Cough DropsExchange Select Honey Lemon Cough Drops recalled 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 (iohexol) Injection 350 mg/mL due to particulate matter.
2 products
FDA•CRITICALBlaine Labs: multiple drugsBlaine Labs recalls multiple topical antiseptic/antifungal gels and creams due to Lysinibacillus fusiformis contamination.
9 products
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 1.5g in 250mL Sodium Chloride InjectionFagron recalls Vancomycin HCl 1.5g/250mL injection due to sterility concern.
5 products
FDA•MODERATEGeri-Care Artificial Tears Lubricant Eye DropsGeri-Care Artificial Tears Lubricant Eye Drops (0.5 oz, NDC 68788-7266-0) recalled due to lack of sterility assurance.
FDA•MODERATEFresenius Kabi: Multiple Sale NDC Number InjectionsFresenius Kabi recalls 14 lots of Sodium Chloride and Dextrose Injections due to sterility concerns.
14 products
FDA•MODERATEMeclizine Hydrochloride Tablets 12.5 mgAmerican Health Packaging is recalling Meclizine Hydrochloride 12.5 mg tablets (NDC 60687-775-65 and 60687-775-11) due to failed tablet specifications.
FDA•MODERATEPrazosin Hydrochloride Capsules 1mgAppco Pharma recalls Prazosin HCl 1mg capsules over nitrosamine impurity (NNP) above acceptable limits.
3 products
FDA•MODERATEK.C. Pharmaceuticals: Multiple Eye DropsK.C. Pharmaceuticals recalls multiple brands of sterile eye drops over sterility concerns.
15 products
FDA•MODERATEBromfenac Ophthalmic Solution 0.07%Alembic Pharmaceuticals is recalling Bromfenac Ophthalmic Solution 0.07% (NDC 62332-583-03) due to failed impurities and degradation specifications.
FDA•MODERATETramadol Hydrochloride Tablets 50 mgAmneal is recalling 500-count bottles of Tramadol Hydrochloride 50 mg tablets due to an impurity found during stability testing.
FDA•MODERATECurosurf (poractant alfa) 240 mg Intratracheal SuspensionChiesi USA is recalling Curosurf 240 mg intratracheal suspension vials (NDC 10122-510-03) due to lack of sterility assurance.
FDA•MODERATEOctreotide Acetate Injectable Suspension 20 mgTeva recalls Octreotide Acetate 20 mg vials over sterility assurance concerns.
6 products
FDA•MODERATENoromycin 300 LA Oxytetracycline InjectionMWI Animal Health is recalling Noromycin 300 LA oxytetracycline injection (NADA# 141-143) due to lack of assurance of sterility.
FDA•MODERATEBrimonidine Tartrate/Timolol Maleate Ophthalmic SolutionApotex is recalling Brimonidine Tartrate/Timolol Maleate eye drops (NDC 60505-0589-1) due to lack of sterility assurance.
FDA•CRITICALMagnesium Sulfate in Water for Injection IV BagsAmneal recalls Magnesium Sulfate IV bags due to product mix-up with Tranexamic Acid.
FDA•MODERATELevothyroxine Sodium Tablets USP 150 mcgMacleods Pharma recalls Levothyroxine Sodium 150 mcg tablets (NDC 33342-401-44) nationwide due to subpotency.
FDA•LOWSodium Iodide I-131 Kit Gelatin Capsule PackRadnostix is recalling Sodium Iodide I-131 Kit capsule packs due to failed product specifications.
FDA•Webcol Large Alcohol Prep PadsCardinal Health recalls Webcol Large Alcohol Prep Pads over microbial contamination risk.
FDA•MODERATEDexamethasone Sodium Phosphate Injection, USP 100 mg/10 mLSomerset Therapeutics is recalling Dexamethasone Sodium Phosphate Injection (NDC 70069-025-10/01) due to out-of-specification impurities at expiry.
FDA•MODERATEIcosapent Ethyl CapsulesZydus Pharmaceuticals is recalling Icosapent Ethyl Capsules due to oxidation, which can cause capsule melting and discoloration.
FDA•CRITICALWebcol Alcohol Prep Pads (70% Isopropyl Alcohol)Cardinal Health is recalling Webcol Alcohol Prep Pads (200-count boxes) due to microbial contamination that may pose infection risk.
3 products
FDA•MODERATEBioCox 60 Type A Medicated ArticleHuvepharma is recalling BioCox 60 Type A Medicated Article due to failure to meet stability specification requirements.
FDA•MODERATEChildren's Ibuprofen Oral Suspension 100 mg/5mLTaro Pharmaceuticals is recalling Children's Ibuprofen Oral Suspension 100 mg/5mL (120 mL) due to gel-like masses and black particles.
FDA•LOWPitavastatin Tablets, 2 mgNorthstar Rx LLC is recalling Pitavastatin Tablets, 2 mg (NDC 72603-479-01) due to a foreign 1 mg tablet found in bottles.
FDA•CRITICALBlue Bull Extreme Male Enhancement SupplementBlue Bull Extreme Male Enhancement recalled due to undeclared sildenafil.
3 products
FDA•MODERATETemozolomide Capsules 5mgRising Pharmaceuticals is recalling Temozolomide Capsules 5mg (NDC 16571-816-51) due to failed impurities and degradation specifications.
FDA•MODERATESemaglutide Injection 2 mg Multi-Dose VialsNew Life Pharma recalls semaglutide 2 mg vials over sterility concerns.
4 products
FDA•MODERATEAmnesteem Isotretinoin Capsules 40 mgMylan is recalling Amnesteem Isotretinoin 40 mg capsules (NDC 0378-6614-93) due to failed dissolution specifications.
FDA•MODERATESodium Iodide (I-131) Therapeutic Oral SolutionRadnostix is recalling Sodium Iodide (I-131) Therapeutic Oral Solution due to the presence of particulate matter.
FDA•MODERATELowes Foods Sour Cream and Onion Potato ChipsUncle Ray's recalls Lowes Foods sour cream & onion chips (8 oz) over inaccurate nutrition and undeclared MSG.
FDA•MODERATEHTO Nevada: Multiple Dermal Source ProductsKirkman recalls Vasocaine Spray and Zone 1/2 Lidocaine Creams over unsupported expiry dates.
3 products
FDA•LOWCipla: Multiple Packaged In Cartons CapsulesCipla recalls Nilotinib 150 mg and 200 mg capsules over failed specification tests.
2 products
FDA•MODERATEMidodrine Hydrochloride Tablets, USP 5 mgMajor Pharmaceuticals is recalling Midodrine Hydrochloride Tablets 5 mg (NDC 0904-6818-06) due to inadequately sealed blister packaging.
FDA•MODERATEACME UNITED: multiple drugsAcme United is recalling 22 varieties of BZK Antiseptic Towelettes due to manufacturing process deviations.
22 products
FDA•MODERATESemaglutide Bulk APIHarbin Jixianglong recalls semaglutide bulk API over CGMP validation failures.
2 products
FDA•MODERATETeva Pharmaceuticals: multiple tabletsTeva recalls Metoprolol Succinate ER tablets (25-200 mg) over failed dissolution specs.
4 products
FDA•LOWEptifibatide Injection 75 mg/100 mLSlate Run Pharmaceuticals recalls Eptifibatide Injection 75 mg/100 mL vials (NDC 70436-027-80, 70436-163-80) due to incorrect dosing-route labeling.