Browse Drug Recalls

1,309 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 1,309 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 1,309 FDA drug recalls in 2014.

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DateProductReasonClassFirm
Oct 6, 2014 CALCIUM CHLORIDE (COMPOUND), 100 mg/mL, Injectable, 10 mL glass vial, RX, Cre... Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not... Class II Oregon Compounding Centers, Inc. dba Creative C...
Oct 6, 2014 PAPAVERINE HCL/PHENTOLAMINE MES/ALPROSTADIL, 22mg/0.8mg/8mcg, injectable, 1.2... Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not... Class II Oregon Compounding Centers, Inc. dba Creative C...
Oct 6, 2014 PAPAV HCL/PHENTOL/PROSTAGL, 12mg/1mg/10mcg, injectable, 1.25 mL glass vial or... Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not... Class II Oregon Compounding Centers, Inc. dba Creative C...
Oct 6, 2014 DMPS-preservative free, 50 mg/mL, injectable, 5 mL glass vial, RX, Creative C... Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not... Class II Oregon Compounding Centers, Inc. dba Creative C...
Oct 6, 2014 CHORIONIC GONADOTROPIN, 5000 Units, sterile powder for reconstitution, glass ... Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not... Class II Oregon Compounding Centers, Inc. dba Creative C...
Oct 6, 2014 COPPER (SULF), 0.4 mg/mL, injectable, 20 mL glass vial, RX, Creative Compound... Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not... Class II Oregon Compounding Centers, Inc. dba Creative C...
Oct 6, 2014 PAPAVERINE/PHENTOLAMINE/PROSTAGLANDIN, 17.16mg/0.57mg/19.45mcg, injectable, 1... Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not... Class II Oregon Compounding Centers, Inc. dba Creative C...
Oct 6, 2014 METHYCOBALAMIN, preservative free, 1mg/mL, injectable, 2 mL glass vial, RX, C... Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not... Class II Oregon Compounding Centers, Inc. dba Creative C...
Oct 6, 2014 GENTAMICIN SULFATE, 480mg/1000mL, solution for irrigation, 300 mL plastic bot... Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not... Class II Oregon Compounding Centers, Inc. dba Creative C...
Oct 6, 2014 DEXPANTHENOL with preservative, 250 mg/mL, injectable, 30 mL glass vial, RX, ... Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not... Class II Oregon Compounding Centers, Inc. dba Creative C...
Oct 6, 2014 VANCOMYCIN, 1mg/0.1mL, injectable, 0.2 mL plastic syringe, RX, Creative Compo... Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not... Class II Oregon Compounding Centers, Inc. dba Creative C...
Oct 6, 2014 ESTRADIOL CYPIONATE (COMPOUNDED/GRAPESEED OIL), 5 mg/mL, injectable, 1 ml gla... Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not... Class II Oregon Compounding Centers, Inc. dba Creative C...
Oct 6, 2014 HYALURONIDASE, 240 u/mL, injectable, 1 mL glass vial, RX, Creative Compounds,... Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not... Class II Oregon Compounding Centers, Inc. dba Creative C...
Oct 6, 2014 CHORIONIC GONADOTROPIN, 4000 Units, sterile powder for reconstitution, glass... Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not... Class II Oregon Compounding Centers, Inc. dba Creative C...
Oct 6, 2014 LIDOCAINE HCL (REPKG-STERILE), 4%, solution for irrigation, 5 mL, 6 mL, and 7... Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not... Class II Oregon Compounding Centers, Inc. dba Creative C...
Oct 6, 2014 GANCICLOVIR, preservative free, 0.2mg/0.05mL, injectable, 0.1 mL plastic syri... Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not... Class II Oregon Compounding Centers, Inc. dba Creative C...
Oct 6, 2014 METHYCOBALAMIN, preservative, 1mg/mL, injectable, 10 mL glass vial, RX, Creat... Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not... Class II Oregon Compounding Centers, Inc. dba Creative C...
Oct 6, 2014 MITOMYCIN, 0.2mg/mL, injectable, 1 mL glass vial, RX, Creative Compounds, Wil... Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not... Class II Oregon Compounding Centers, Inc. dba Creative C...
Oct 6, 2014 ASCORBIC ACID (with Preservative), 500 mg/mL, injectable, 100 mL glass vial, ... Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not... Class II Oregon Compounding Centers, Inc. dba Creative C...
Oct 6, 2014 ASCORBIC ACID (B), 500 mg/mL, injectable, 100 mL glass vial, RX, Creative Co... Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not... Class II Oregon Compounding Centers, Inc. dba Creative C...
Oct 6, 2014 TRIESENCE, 8mg/2.0mL, Injectable, 0.2 mL plastic syringe, RX, Creative Compou... Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not... Class II Oregon Compounding Centers, Inc. dba Creative C...
Oct 6, 2014 TESTOSTERONE CYPIONATE (SESAME OIL/CMPD), 200mg/mL, injectable, 5 mL glass vi... Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not... Class II Oregon Compounding Centers, Inc. dba Creative C...
Oct 6, 2014 DEXAMETHASONE (AS SOD PHOS), 24 mg/mL, injectable, 1 mL glass vial, RX, Creat... Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not... Class II Oregon Compounding Centers, Inc. dba Creative C...
Oct 6, 2014 PREDNISOLONE Sodium Phosphate, 1%, Ophthalmic, 1 mL plastic dropper bottle, R... Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not... Class II Oregon Compounding Centers, Inc. dba Creative C...
Oct 6, 2014 OMNIPAQUE, 300mgI/mL, injectable, 2 mL glass vial, RX, Creative Compounds, Wi... Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not... Class II Oregon Compounding Centers, Inc. dba Creative C...
Oct 6, 2014 Vancomycin Hydrochloride for Injection, USP, 1 g Sterile Powder per Fliptop V... Temperature Abuse: Products experienced uncontrolled temperature excursions during transit. Class II Hospira Inc.
Oct 6, 2014 HYDROXOCOBALAMIN- preservative (B12), 1mg/mL, injectable, 10 mL glass vial, R... Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not... Class II Oregon Compounding Centers, Inc. dba Creative C...
Oct 6, 2014 GLUTARALDEHYDE BUFFERED (POTASSIUM PHOSPHATE), solution for irrigation, 250 ... Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not... Class II Oregon Compounding Centers, Inc. dba Creative C...
Oct 6, 2014 ALPROSTADIL/LIDOCAINE HCL, 20mcg/5mg/mL, 1.25 mL glass vial, RX, Creative Co... Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not... Class II Oregon Compounding Centers, Inc. dba Creative C...
Oct 6, 2014 PAPAVERINE/PHENTOLAMINE/ALPROSTADIL, 26.5mg/0.98mg/58.9mcg, injectable, 1.25 ... Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not... Class II Oregon Compounding Centers, Inc. dba Creative C...
Oct 6, 2014 MITOMYCIN, 0.3mg/mL, injectable, 1 mL glass vial, RX, Creative Compounds, Wil... Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not... Class II Oregon Compounding Centers, Inc. dba Creative C...
Oct 6, 2014 PYRIDOXINE HCL, with preservative, 100 mg/mL, injectable, 30 mL glass vial, R... Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not... Class II Oregon Compounding Centers, Inc. dba Creative C...
Oct 6, 2014 VITAMIN B COMPLEX (PRES) injectable, 100mg, 10 mL glass vial, RX, Creative Co... Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not... Class II Oregon Compounding Centers, Inc. dba Creative C...
Oct 6, 2014 HYDROXOCOBALAMIN-preservative free (B12), 1mg/mL, injectable, 2 mL glass vial... Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not... Class II Oregon Compounding Centers, Inc. dba Creative C...
Oct 6, 2014 PAPAVERINE/PHENTOLAMINE/PROSTAGLANDIN, 17.44mg/0.64mg/5.8mcg, injectable, 1.7... Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not... Class II Oregon Compounding Centers, Inc. dba Creative C...
Oct 6, 2014 Ketorolac Tromethamine Inj., USP, 60 mg (30 mg/mL), 2 mL Single-dose Fliptop ... Temperature Abuse: Products experienced uncontrolled temperature excursions during transit. Class II Hospira Inc.
Oct 6, 2014 TOBRAMYCIN, 480mg/1000 mL, solution for irrigation, 500 mL plastic bottle, RX... Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not... Class II Oregon Compounding Centers, Inc. dba Creative C...
Oct 6, 2014 BEVACIZUMAB/DEXAMETHASONE, 1.25/0.5 mL, Injectable, 0.05 mL plastic syringe, ... Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not... Class II Oregon Compounding Centers, Inc. dba Creative C...
Oct 6, 2014 GANCICLOVIR -preservative free, 2mg/0.1mL, injectable, 0.1 mL plastic syringe... Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not... Class II Oregon Compounding Centers, Inc. dba Creative C...
Oct 6, 2014 PAPAVERINE HCL, with preservative, 30 mg/mL, injectable, 1.25 mL glass vial, ... Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not... Class II Oregon Compounding Centers, Inc. dba Creative C...
Oct 6, 2014 PAPAVERINE HCL/PHENTOLAMINE/PROSTAGLANDIN, 27.7mg/0.45mg/45.45mcg, injectable... Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not... Class II Oregon Compounding Centers, Inc. dba Creative C...
Oct 6, 2014 GLUTATHIONE, 100 mg/mL, injectable, 100 mL glass vial, RX, Creative Compounds... Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not... Class II Oregon Compounding Centers, Inc. dba Creative C...
Oct 6, 2014 GLUTATHIONE with preservative, 100mg/mL, injectable, 100 mL glass vial, RX, C... Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not... Class II Oregon Compounding Centers, Inc. dba Creative C...
Oct 6, 2014 PAPAVERINE HCL/PHENTOLAMINE MES/PROSTAGLANDIN, 23mg/0. 96mg/19.23mcg, injecta... Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not... Class II Oregon Compounding Centers, Inc. dba Creative C...
Oct 6, 2014 TESTOSTERONE CYPIONATE (GRAPE SEED OIL/COMPOUNDED), 200mg/mL, injectable, 5 m... Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not... Class II Oregon Compounding Centers, Inc. dba Creative C...
Oct 6, 2014 METHYCOBALAMIN, preservative free, 20mg/mL, injectable, 0.3 mL or 1 mL glass ... Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not... Class II Oregon Compounding Centers, Inc. dba Creative C...
Oct 6, 2014 Propofol Injectable Emulsion, 1%, 200 mg/20 mL (10 mg/mL), 20 mL Single patie... Temperature Abuse: Products experienced uncontrolled temperature excursions during transit. Class I Hospira Inc.
Oct 6, 2014 ALPROSTADIL, 10 mcg/mL, injectable, 1.7 mL glass vial, RX, Creative Compounds... Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not... Class II Oregon Compounding Centers, Inc. dba Creative C...
Oct 6, 2014 CITRIC ACID/GLUCONOLACTONE MAGNES CARB (RENACIDIN), 66/1.98/31.77 mg/mL, solu... Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not... Class II Oregon Compounding Centers, Inc. dba Creative C...
Oct 6, 2014 METHYCOBALAMIN, preservative free, 10mg/mL, injectable, 1 mL glass vial, RX, ... Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not... Class II Oregon Compounding Centers, Inc. dba Creative C...

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.