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Browse Drug Recalls

6,256 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 6,256 FDA drug recall enforcement actions. Each entry includes the product description, reason for recall, classification (Class I through III based on severity), recalling firm, and distribution details. Use the filters below to search by year, classification, state, or keyword.

Drug Safety Recalls

Browse 6,256 FDA drug recalls.

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DateProductReasonClassFirm
Sep 12, 2015 HCG/B12 (5,000 units, 0.6 mg) 5 mL, Multi-Dose Vial, For IM or SC Injection, ... Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within ex... Class II US Compounding Inc
Sep 12, 2015 Morphine PF (2 mg/2 mL), 2 mL Single Use Vial, For IV or IM Administration, R... Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within ex... Class II US Compounding Inc
Sep 12, 2015 Tropicamide 0.5%/ Phenylephrine 5%, 2 mL Dropper Bottle For Topical Ophthalm... Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within ex... Class II US Compounding Inc
Sep 12, 2015 Phenylephrine 1.5%/ Lidocaine 1%, 1 mL Single Use Vial, For Intracameral Inje... Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within ex... Class II US Compounding Inc
Sep 12, 2015 Dex Combo (Dexamethasone acetate 8mg/mL, dexamethasone sodium phosphate USP, ... Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within ex... Class II US Compounding Inc
Sep 12, 2015 Alprostadil (PGE-1), 5 mL (40 mcg/mL) in 10 mL Multi-Dose Vial, Rx only, Comp... Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within ex... Class II US Compounding Inc
Sep 12, 2015 Triamcinolone diacetate USP (40 mg/mL), 30 mL Multi-Dose Vial, For IM & Regio... Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within ex... Class II US Compounding Inc
Sep 12, 2015 Cyclo/PE/Trop PF (1%/2.5%/1%), 3 mL dropper bottle, For topical ophthalmic us... Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within ex... Class II US Compounding Inc
Sep 12, 2015 Triamcinolone/Lidocaine (40 mg/1%/mL), 10 mL Multidose Vial, For IM & Regiona... Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within ex... Class II US Compounding Inc
Sep 12, 2015 Glycopyrrolate USP ( 1 mg/5 mL), 5 mL Single Use syringe, For IM or IV Injec... Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within ex... Class II US Compounding Inc
Sep 12, 2015 Betamethasone SP, 2 mL (6 mg/mL),10 mL Multi-Dose Vial, For IM & Regional Inj... Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within ex... Class II US Compounding Inc
Sep 12, 2015 Voriconazole Solution (1%(10 mg/mL), 15 mL dropper bottle; For Topical Ophtha... Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within ex... Class II US Compounding Inc
Sep 12, 2015 Cyclo/PE/Tropic/Ketor (1%/2.5%/1%/0.5%), 10 mL Opthalmic dropper bottle, For ... Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within ex... Class II US Compounding Inc
Sep 12, 2015 MedroxyPROGESTERone/Lidocaine (150 mg/mL/1%) 10 mL Multi-Dose Vial, For IM In... Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within ex... Class II US Compounding Inc
Sep 12, 2015 Phenylephrine PF (1 mg/10 mL), 10 mL Single Use Syringe, For IV Use, Rx only,... Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within ex... Class II US Compounding Inc
Sep 12, 2015 Lincomycin/Lidocaine (300 mg/1%/mL), 10 mL Multi-Dose Vial, For IV Injection ... Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within ex... Class II US Compounding Inc
Sep 12, 2015 L-Cysteine PF (50 mg/mL), 10 mL Single Dose Vial, For IV Use After Dilution, ... Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within ex... Class II US Compounding Inc
Sep 12, 2015 Vancomycin Ophthalmic PF 0.5 mL (5 mg/0.5 mL (10 mg/mL), 1 mL syringe, For To... Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within ex... Class II US Compounding Inc
Sep 12, 2015 Triamcinolone acetonide, USP (50 mg/mL), 10 mL Multi-Dose Vial, For IM & Regi... Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within ex... Class II US Compounding Inc
Sep 12, 2015 Bi-Mix (Papaverine 30 mg/mL, Phentolamine 1 mg/mL), 5 mL Multi-Dose Vial, Rx ... Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within ex... Class II US Compounding Inc
Sep 12, 2015 Betamethasone Combo 10 mL (7 mg/mL), 10 mL Multi-Dose Vial,for IM & Regional ... Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within ex... Class II US Compounding Inc
Sep 12, 2015 Tri-Mix 30/1/10 (papaverine HCL USP 30 mg/ phentolamine mesylate USP 1 mg/ al... Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within ex... Class II US Compounding Inc
Sep 12, 2015 Phenylephrine PF Sterile Solution (2.5%), 3 mL Single Use Ophthalmic Dropper ... Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within ex... Class II US Compounding Inc
Sep 12, 2015 Brompheniramine Maleate (10 mg/mL), 10 mL Multi-Dose Vial, Rx only, Compounde... Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within ex... Class II US Compounding Inc
Sep 12, 2015 MIC Combo (Methionine 25 mg/mL, Inositol 50 mg/mL, Choline chloride 50 mg/mL,... Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within ex... Class II US Compounding Inc
Sep 12, 2015 ePHEDrine Sulfate PF (50 mg/10 mL), 10 mL Single-Use Syringe, For IV or IM Us... Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within ex... Class II US Compounding Inc
Sep 12, 2015 MethylPREDNISolone (100 mg/mL) 10 mL Multi-Dose Vial, For IM & Regional Injec... Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within ex... Class II US Compounding Inc
Sep 12, 2015 Trace Elements-4 (Zinc Sulfate heptahydrate 4.39 mg, Cupric Sulfate pentahydr... Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within ex... Class II US Compounding Inc
Sep 12, 2015 Neostigmine (5 mg/5 mL), 5 mL Single Use Syringe, For IM, SC or Slow IV Inje... Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within ex... Class II US Compounding Inc
Sep 12, 2015 Pilocarpine (1/16%) Ophthalmic, 15 mL dropper bottle, Rx only, Compounded by ... Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within ex... Class II US Compounding Inc
Sep 12, 2015 Prednisolone Sodium Phosphate PF Solution (1%) in 15 mL dropper bottle; For T... Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within ex... Class II US Compounding Inc
Sep 12, 2015 Dapiprazole (Diluent+Powder) 0.5% in 5 mL vial, For topical ophthalmic use, ... Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within ex... Class II US Compounding Inc
Sep 12, 2015 Hyaluronic Acid/Lidocaine (20 mg/1%/2 mL), 3 mL Single Use Syringe, For Intra... Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within ex... Class II US Compounding Inc
Sep 12, 2015 Triamcinolone diacetate USP PF (40 mg/mL), 2 mL Vial, For IM & Regional Inje... Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within ex... Class II US Compounding Inc
Sep 12, 2015 ACETYLCYSTEINE 10% OPHTALMIC, 10 mL dropper bottle; For topical ophthalmic us... Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within ex... Class II US Compounding Inc
Sep 12, 2015 Choline chloride 50 mg/mL, Inositol 50 mg/mL Cyanocobalamin 1000 mcg/mL, 30 m... Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within ex... Class II US Compounding Inc
Sep 12, 2015 Succinylcholine Chloride (200 mg/10 mL), 10 mL Single Use Syringe (20 mg/mL),... Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within ex... Class II US Compounding Inc
Sep 12, 2015 Hyaluronic Acid/Lidocaine PF (20 mg/1%), 2 mL Single-Use Syringe , For Intra-... Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within ex... Class II US Compounding Inc
Sep 12, 2015 Hyaluronidase PF (150 units/mL) in 1 mL Single-Use Vial, Not for IV Use, Rx o... Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within ex... Class II US Compounding Inc
Sep 12, 2015 Zinc Sulfate (1 mg/mL), 10 mL Single Dose Vial, For IV Use After Dilution, R... Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within ex... Class II US Compounding Inc
Sep 12, 2015 Phenylephrine 10% PF Ophthalmic Solution, 3 mL dropper bottle, For Topical Op... Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within ex... Class II US Compounding Inc
Sep 12, 2015 Testosterone EO-Pro-Cyp 220 (220 mg/mL) 30 mL Multi-Dose Vial, For Deep IM In... Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within ex... Class II US Compounding Inc
Sep 12, 2015 Dexamethasone Sodium Phosphate PF (10 mg/mL), 2 mL Single Use Vial, For IV or... Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within ex... Class II US Compounding Inc
Sep 12, 2015 Betamethasone Combo PF 2 mL (6 mg/mL) 10 mL Multi-Dose Vial, For IM & Region... Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within ex... Class II US Compounding Inc
Sep 12, 2015 Methylcobalamin (12.5 mg/mL), 2.5 mL Multi-Dose Vial, For IM or SC Injection,... Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within ex... Class II US Compounding Inc
Sep 12, 2015 Lidocaine 1% PF(100 mg/10 mL),10 mL Single Use Syringe, For IV Injection, Rx ... Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within ex... Class II US Compounding Inc
Sep 12, 2015 Hyaluronic Acid/Lidocaine PF (60 mg/2%), 3 mL Single Use Syringe, For Intra-A... Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within ex... Class II US Compounding Inc
Sep 12, 2015 Cyclopent/PE/Tropic 2mL (1%/2.5%/0.25%), 2 mL dropper bottles; For topical op... Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within ex... Class II US Compounding Inc
Sep 12, 2015 Tropicamide 1%/Phenylephrine 2.5% (tropicamide USP 10 mg/ phenylephrine HCL U... Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within ex... Class II US Compounding Inc
Sep 12, 2015 Betamethasone SP PF (12 mg/mL), 2 mL Single Dose Vial, For IM & Regional Inje... Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within ex... Class II US Compounding Inc

Frequently Asked Questions

When a drug safety issue is identified — through FDA inspections, laboratory testing, adverse event reports, or manufacturer quality checks — the responsible company issues a recall to remove the affected products from the market. Pharmacies pull the product from shelves, and consumers are advised to contact their healthcare provider for alternatives.

The leading causes include cGMP deviations, impurity contamination (including nitrosamines like NDMA), failed dissolution or stability testing, sterility issues, potency problems, labeling errors, and foreign particle contamination.

Use the search and filter tools on this page to look up specific medications, active ingredients, or manufacturers. Each recall entry includes the product description, lot numbers, and distribution details.