FDA•MODERATE
Phenylephrine Hydrochloride Injectable Solution
Wells Pharma is recalling Phenylephrine Hydrochloride Injectable Solution (40mg, 250mL) distributed nationwide due to cGMP deviations.
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FDA•LOWMagnesium Chloride 6-Hydrate Crystal 500GAvantor is recalling Magnesium Chloride 6-Hydrate Crystal 500G bottles (NDC 10106-2448-1) due to subpotency.
FDA•MODERATEPrazosin Hydrochloride Capsules 1mgAppco Pharma is recalling Prazosin Hydrochloride 1mg capsules due to the presence of N-nitroso-prazosin (NNP) impurity above acceptable limits.
3 products
FDA•MODERATEPantoprazole Sodium Delayed-Release Tablets 40 mgCamber Pharmaceuticals is recalling Pantoprazole Sodium 40 mg tablets (NDC 31722-713-10) due to discoloration.
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•MODERATEFluocinonide 0.05% CreamTaro Pharmaceuticals is recalling Fluocinonide 0.05% Cream due to out-of-specification viscosity results.
3 products
FDA•MODERATEOmnipaque (iohexol) InjectionGE Healthcare is recalling Omnipaque (iohexol) injection due to the presence of particulate matter.
2 products
FDA•MODERATEMemantine Hydrochloride Extended-Release 7 mg CapsulesMajor Pharmaceuticals is recalling Memantine Hydrochloride Extended-Release 7 mg capsules (NDC 0904-6734-61) due to failed dissolution specifications.
FDA•MODERATEVancomycin HCl InjectionFagron is recalling Vancomycin HCl 1.5g/250mL injections distributed nationwide due to sterility concerns and potential port detachment.
5 products
FDA•MODERATEExchange Select Honey Lemon Cough DropsExchange Select Honey Lemon Cough Drops are being recalled due to manufacturing quality concerns.
15 products
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•MODERATETramadol Hydrochloride Tablets, USP 50 mgAmneal is recalling tramadol 50 mg tablets (NDC 60219-2348-5) due to elevated N-nitroso-desmethyl-tramadol impurity.
FDA•MODERATEClonidine Transdermal System 0.2 mg/dayTeva Pharmaceuticals is recalling Clonidine Transdermal System 0.2 mg/day due to the use of an unapproved raw material during manufacturing.
3 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•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•LOWRemedy Gel Hydrocortisone 1%Island Kinetics is recalling Remedy Gel hydrocortisone 1% due to subpotency.
3 products
FDA•MODERATEOctreotide Acetate for Injectable SuspensionTeva is recalling Octreotide Acetate for Injectable Suspension due to a lack of assurance of sterility.
6 products
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•MODERATEXanax XR Alprazolam 3 mg TabletsViatris is recalling Xanax XR 3 mg tablets (NDC 58151-506-91) due to failed dissolution specifications.
FDA•MODERATEAlbuterol Sulfate Inhalation Solution 0.5%Nephron SC recalling Albuterol Sulfate Inhalation Solution (NDC 69374-330-05) due to illegible labeling.
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•MODERATECinacalcet Hydrochloride TabletsCipla is recalling Cinacalcet Hydrochloride Tablets due to the presence of N-Nitroso Cinacalcet above acceptable limits.
3 products
FDA•MODERATELanreotide Injection 120 mg/0.5 mLCipla is recalling Lanreotide Injection 120 mg/0.5 mL due to a lack of assurance of sterility.
2 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•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•MODERATE0.9% Sodium Chloride Injection, USPFresenius Kabi is recalling 0.9% Sodium Chloride Injection, USP, 250 mL bags due to a lack of assurance of sterility.
14 products
FDA•MODERATEIcosapent Ethyl Capsules, 1 gramZydus Pharmaceuticals is recalling Icosapent Ethyl Capsules (NDC 70710-1592-7) due to oxidized ingredient causing red dots and melted capsules.
FDA•MODERATESemaglutide-Glycine-Cyanocobalamin InjectableNorthwest Compounders is recalling Semaglutide-Glycine-Cyanocobalamin Injectable vials 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•MODERATETemozolomide Capsules 5mgRising Pharmaceuticals is recalling Temozolomide Capsules 5mg (NDC 16571-816-51) due to failed impurities and degradation specifications.
FDA•MODERATEArtificial Tears Sterile Lubricant Eye DropsK.C. Pharmaceuticals is recalling various brands of Artificial Tears eye drops nationwide due to a lack of assurance of sterility.
15 products
FDA•MODERATEFarmhouse Fresh Midnight Clearing Night LotionFarmhouse Fresh is recalling Midnight Clearing Night Lotion acne treatment due to benzene contamination.
4 products
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•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•MODERATELevothyroxine Sodium Tablets USP 150 mcgMacleods Pharma recalls Levothyroxine Sodium 150 mcg tablets (NDC 33342-401-44) nationwide due to subpotency.
FDA•MODERATENomida Semaglutide InjectionNomida is recalling Semaglutide Injection 2 mg vials (NDC 84223-001-06) due to a lack of assurance of sterility.
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•LOWGelatin Capsule Pack for Sodium Iodide I-131 KitInternational Isotopes recalling Gelatin Capsule Packs (NDC 69208-003-15/25/35) for Sodium Iodide I-131 Kit due to failed specifications.
FDA•MODERATEBioCox 60 Type A Medicated ArticleHuvepharma is recalling BioCox 60 Type A Medicated Article due to failure to meet stability specification requirements.
FDA•LOWNilotinib Capsules 150 mgCipla is recalling Nilotinib Capsules 150 mg due to failed stability specifications observed during long-term testing.
2 products
FDA•MODERATEVasocaine SprayVasocaine Spray is being recalled because stability data does not support the assigned expiration date.
3 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•MODERATESemaglutide Compounding IngredientHarbin Jixianglong Biotech is recalling Semaglutide for compounding use due to CGMP deviations regarding process and endotoxin validation.
2 products
FDA•MODERATEAmantadine HCl Capsules 100 mgAvKARE is recalling Amantadine HCl Capsules 100 mg (NDC 50268-069-15) nationwide due to failed dissolution specifications.
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.
FDA•CRITICALWhite Vein Advanced Alkaloids Chewable TabletsShaman Botanicals is recalling White Vein Advanced Alkaloids Chewable Tablets due to higher-than-labeled levels of 7-hydroxymitragynine.
2 products
FDA•MODERATEAdbry (tralokinumab-ldrm) Injection 300 mg/2mLLEO Pharma is recalling Adbry injection autoinjectors (NDC 50222-350-91, 50222-350-02) due to wool fiber contamination affecting sterility.
FDA•MODERATECetrorelix Acetate for Injection Kit 0.25 mgMeitheal Pharmaceuticals recalls Cetrorelix Acetate injection kits (NDC 71288-558-90) due to missing or duplicated needles.
FDA•MODERATEThiamine HCl InjectionFagron Sterile Services is recalling Thiamine HCl 500 mg injection due to a lack of assurance of sterility.
5 products
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.