FDA•MODERATE
Omega-3-Acid Ethyl Esters Capsules
Major Pharmaceuticals is recalling Omega-3-Acid Ethyl Esters Capsules due to failed stability testing for capsule shell loss on drying.
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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•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•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
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 Unit Of Sale Ndc Number ProductsFresenius Kabi recalls 14 lots of IV saline and dextrose solutions over 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 above acceptable limits.
3 products
FDA•MODERATEK.C. Pharmaceuticals: Multiple Eye Drops ProductsK.C. Pharmaceuticals recalls multiple brands of sterile eye drops due to lack of sterility assurance.
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 concerns from FDA inspection findings.
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•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•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•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•MODERATETemozolomide Capsules 5mgRising Pharmaceuticals is recalling Temozolomide Capsules 5mg (NDC 16571-816-51) due to failed impurities and degradation specifications.
FDA•MODERATENomida Semaglutide InjectionNew Life Pharma recalls Nomida Semaglutide Injection 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 ChipsLowes Foods Sour Cream and Onion potato chips are recalled for inaccurate sodium labeling and undeclared monosodium glutamate.
FDA•MODERATEHTO Nevada: Multiple Dermal Source ProductsKirkman recalls lidocaine cream and spray due to unsupported expiry dates.
3 products