FDA•MODERATE
Brimonidine Tartrate/Timolol Maleate Ophthalmic Solution
Apotex is recalling Brimonidine Tartrate/Timolol Maleate eye drops (NDC 60505-0589-1) due to lack of sterility assurance.
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Drugs Recalls
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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•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.
FDA•MODERATEAmantadine HCl Capsules 100 mgAvKARE is recalling Amantadine HCl Capsules 100 mg (NDC 50268-069-15) nationwide due to failed dissolution specifications.
FDA•MODERATEAdbry (tralokinumab-ldrm) InjectionLEO Pharma is recalling Adbry (tralokinumab-ldrm) injection due to a lack of sterility assurance following the discovery of wool fiber.
FDA•MODERATEOxycodone Hydrochloride 5 mg TabletsAmerican Health Packaging is recalling Oxycodone 5 mg tablets due to defective blister card seals that may cause tablets to fall out.
FDA•MODERATECetrorelix Acetate Injection KitMeitheal Pharmaceuticals is recalling Cetrorelix Acetate injection kits due to missing or duplicated needles in the delivery system.
FDA•MODERATEThiamine HCl Injection 500 mg/100 mLFresenius Kabi recalls thiamine HCl 500 mg/100 mL IV bags over sterility concerns.
5 products
FDA•MODERATETestosterone 100 mg Sterile PelletsAsteria Health recalls Testosterone 100 mg Sterile Pellets over possible metal contamination.
25 products
FDA•MODERATEDiclofenac Sodium Topical Gel 3%Taro Pharmaceuticals is recalling Diclofenac Sodium Topical Gel 3% (100 g) due to viscosity specification failure.
FDA•LOWDoxazosin Tablets, USP 4 mgUnichem is recalling Doxazosin Tablets 4 mg (NDC 29300-353-10) due to incorrect tablet imprinting that may cause medication errors.
FDA•MODERATETrazodone Hydrochloride 50 mg TabletsGranules Pharmaceuticals is recalling Trazodone Hydrochloride 50 mg tablets (NDC 70010-231-01) due to foreign tablets or capsules in bottles.
FDA•MODERATEPro Numb Tattoo Numbing SprayPro Numb Tattoo Numbing Spray recalled over cGMP deviations.
2 products
FDA•MODERATEBisoprolol Fumarate and Hydrochlorothiazide Tablets 2.5 mg/6.25 mgUnichem Pharmaceuticals recalls Bisoprolol/Hydrochlorothiazide 2.5/6.25 mg tablets (NDC 29300-187-01) due to N-Nitroso Bisoprolol impurity specification failure.
FDA•MODERATEMethylprednisolone Tablets USP Dosepak 4 mgGreenstone is recalling methylprednisolone 4 mg tablets (NDC 59762-4440-2) due to incorrect blister foil orientation causing incorrect dosing information.
FDA•MODERATEFurosemide Tablets USP 40 mgRising Pharmaceuticals is recalling Furosemide Tablets 40 mg (NDC 64980-563-10) due to foreign substance contamination.
FDA•MODERATEThyroid, USPSpecialty Process Labs is recalling Thyroid, USP (NDC 81305-100-02) due to subpotency.
FDA•MODERATELanreotide Injection 120 mg/0.5 mLCipla is recalling Lanreotide Injection 120 mg/0.5 mL due to the presence of particulate matter.
FDA•MODERATEAQ 120 GFEW Aquarion Preserved CartridgesEncon Safety Products is recalling AQ 120 GFEW Aquarion Preserved Cartridges due to cGMP manufacturing deviations.