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Browse Drug Recalls

1,733 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 1,733 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 1,733 FDA drug recalls in 2015.

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DateProductReasonClassFirm
Sep 18, 2015 INTRALIPID (fat emulsion), Packaged in a) 27ML Homepumps, b) 125ML Homepumps,... Lack of Assurance of Sterility: Product sterility cannot be guaranteed. Class II Sentara Enterprises
Sep 18, 2015 GENTAMICIN, Packaged as a) 70MG in 70ML Homepumps, b) 80MG in 80ML Homepumps,... Lack of Assurance of Sterility: Product sterility cannot be guaranteed. Class II Sentara Enterprises
Sep 18, 2015 DOBUTAMINE HCL in D5W, Packaged as a) 240MG in 60ML Homepumps and b) 1520MG i... Lack of Assurance of Sterility: Product sterility cannot be guaranteed. Class II Sentara Enterprises
Sep 18, 2015 SOLUMEDROL (methylprednisolone succinate) 1GM in NS, Packaged in 100ML Homepu... Lack of Assurance of Sterility: Product sterility cannot be guaranteed. Class II Sentara Enterprises
Sep 18, 2015 Cancidas (caspofungin acetate) 58.4MG in NS, Packaged in 116.8ML Homepumps, R... Lack of Assurance of Sterility: Product sterility cannot be guaranteed. Class II Sentara Enterprises
Sep 18, 2015 VANCOMYCIN HCL, Packaged as: a) 600MG in 120ML Homepumps, b) 750MG in 150ML H... Lack of Assurance of Sterility: Product sterility cannot be guaranteed. Class II Sentara Enterprises
Sep 18, 2015 ZOSYN (pipericillin/tazobactam) in NS, Packaged as a) 3.375GM in 50ML Homepum... Lack of Assurance of Sterility: Product sterility cannot be guaranteed. Class II Sentara Enterprises
Sep 18, 2015 MYCAMINE (micafungin sodium) 150MG, Packaged in 150ML Homepumps, Rx Only. SEN... Lack of Assurance of Sterility: Product sterility cannot be guaranteed. Class II Sentara Enterprises
Sep 18, 2015 Tobramycin 120MG, Packaged in 150ML Homepumps, Rx Only. SENTARA HOME HEALTH S... Lack of Assurance of Sterility: Product sterility cannot be guaranteed. Class II Sentara Enterprises
Sep 18, 2015 Ampicillin/Sulbactam 12GM in NS, Packaged in 600ML Homepumps, Rx Only. SENTAR... Lack of Assurance of Sterility: Product sterility cannot be guaranteed. Class II Sentara Enterprises
Sep 18, 2015 GANCICLOVIR in NS, Packaged as a) 320MG in 64ML Homepumps and b) 2440MG in 48... Lack of Assurance of Sterility: Product sterility cannot be guaranteed. Class II Sentara Enterprises
Sep 18, 2015 SOD CHLORIDE (Sodium Chloride), Packaged in a) 0.9% in 30ML Homepumps, b) 0.9... Lack of Assurance of Sterility: Product sterility cannot be guaranteed. Class II Sentara Enterprises
Sep 18, 2015 Nafcillin 2GM in NS, Packaged in 50ML Homepumps, Rx Only. SENTARA HOME HEALTH... Lack of Assurance of Sterility: Product sterility cannot be guaranteed. Class II Sentara Enterprises
Sep 18, 2015 Solu-Cortef (hydrocortisone) 1MG in NS, Packaged in 0.1ML Syringe, Rx Only. S... Lack of Assurance of Sterility: Product sterility cannot be guaranteed. Class II Sentara Enterprises
Sep 18, 2015 Invanz (ertapenem) Injection Recon Soln in NS, Packaged as a) 500MG in 50ML H... Lack of Assurance of Sterility: Product sterility cannot be guaranteed. Class II Sentara Enterprises
Sep 18, 2015 PENICILLIN in D5W, Packaged as a)36MU in 360ML Homepumps and b) 51MU in 510ML... Lack of Assurance of Sterility: Product sterility cannot be guaranteed. Class II Sentara Enterprises
Sep 18, 2015 ASCORBIC ACID 500MG/Syringe, Packaged in 1ML Syringes, Rx Only. SENTARA HOME ... Lack of Assurance of Sterility: Product sterility cannot be guaranteed. Class II Sentara Enterprises
Sep 18, 2015 Milrinone in 0.45% NS, Packaged as a) 52MG in 65ML Homepumps, b) 80MG in 100M... Lack of Assurance of Sterility: Product sterility cannot be guaranteed. Class II Sentara Enterprises
Sep 18, 2015 CEFAZOLIN, Packaged as a) 625MG in 6.2ML Syringes, b) 2GM in 20ML Syringes, c... Lack of Assurance of Sterility: Product sterility cannot be guaranteed. Class II Sentara Enterprises
Sep 18, 2015 AZACTAM (aztreonam) 2GM in NS, Packaged in 100ML Homepumps, Rx Only. SENTARA ... Lack of Assurance of Sterility: Product sterility cannot be guaranteed. Class II Sentara Enterprises
Sep 18, 2015 CLINDAMYCIN 120MG in NS, Package in 20ML Homepumps, Rx Only. SENTARA HOME HEA... Lack of Assurance of Sterility: Product sterility cannot be guaranteed. Class II Sentara Enterprises
Sep 18, 2015 Dextrose-5% Lactated Ringers, Packaged in 3000ML Homepumps, Rx Only. SENTARA ... Lack of Assurance of Sterility: Product sterility cannot be guaranteed. Class II Sentara Enterprises
Sep 18, 2015 HYDROMORPHONE HCL, Packaged as a) 2.5MG in 1ML Syringes, b) 150MG in 75ML Hom... Lack of Assurance of Sterility: Product sterility cannot be guaranteed. Class II Sentara Enterprises
Sep 18, 2015 Lactated Ringers, Packaged in a) 1500ML Homepumps, b) 2800ML Homepumps, and c... Lack of Assurance of Sterility: Product sterility cannot be guaranteed. Class II Sentara Enterprises
Sep 18, 2015 Dextrose-NaCl (D5-1/2NS) in NS, Packaged in a) 1700ML Homepumps, b) 1800ML H... Lack of Assurance of Sterility: Product sterility cannot be guaranteed. Class II Sentara Enterprises
Sep 17, 2015 WellPatch¿ Capsaicin Pain Relief Patch, 0.025% Natural Capsaicin, External An... Labeling: Incorrect Instructions; The word not is missing from the following sentences "do band... Class II The Mentholatum Co.
Sep 16, 2015 UN1002 Air, Compressed, Breathing Grade, USP, Distributed by Praxair Distribu... CGMP Deviations: Confirmed customer compliant of odor when turning on a cylinder of medical air. Class III Praxair Inc.
Sep 16, 2015 UN1002 Air, Compressed, Medical Air, USP, Distributed by Praxair Distribution... CGMP Deviations: Confirmed customer compliant of odor when turning on a cylinder of medical air. Class III Praxair Inc.
Sep 12, 2015 Fentanyl PF 50 mL (25 mcg/mL), 10 mL Single Use Syringe, For IV, IM or SC 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 MethylPREDNISolone PF (80 mg/mL), 1 mL Single Use 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 Dex LA 8 (Dexamethasone acetate (8 mg/mL), 10 mL Multi-Dose Vial, For IM & Re... 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/Lidocaine (40 mg/mL/1%) 10 mL Multi-Dose Vial, For IM & Re... 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, 30 mL Multi-Dose Vial, For Deep IM Injection Only, Rx only, Compou... 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 cypionate, USP (250 mg/mL), 10 mL Multi-Dose Vial, For Deep IM I... Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within ex... Class II US Compounding Inc
Sep 12, 2015 Vitamin D3 in Olive Oil (50,000 IU/mL) 30 mL vial, For IM Use only, 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 Phenylephrine (1 mg/mL), 5 mL Multi-Dose Vial, For SC, IM, IV or penile 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 Omnipaque 300 (600 mg/2 mL), 2 mL Single Use Vial (300 mg/mL), For IV or IT I... 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
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 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 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 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 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 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 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 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 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 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 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 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

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.