Browse Drug Recalls

6,348 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 6,348 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 6,348 FDA drug recalls.

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DateProductReasonClassFirm
Nov 7, 2014 Sodium Tetradecyl SO4 0.3% Inj., 30 Ml vials, Compounded Rx, Perry Drug Compo... Lack of sterility assurance;All lots of sterile products compounded by the pharmacy that are with... Class II Perry Drug Inc.
Nov 7, 2014 HCG 10,000 U/ 10 mL PF Inj, 8Ml vials, Compounded Rx, Perry Drug Compounding ... Lack of sterility assurance;All lots of sterile products compounded by the pharmacy that are with... Class II Perry Drug Inc.
Nov 7, 2014 Tri Mix PF SYR 0.5 mL Inj., Compounded Rx, 10 each, Compounded Rx, Perry Drug... Lack of sterility assurance;All lots of sterile products compounded by the pharmacy that are with... Class II Perry Drug Inc.
Nov 7, 2014 Tri-mix Antidote 10 each Syringes, Compounded Rx, Perry Drug Compounding Phar... Lack of sterility assurance;All lots of sterile products compounded by the pharmacy that are with... Class II Perry Drug Inc.
Nov 7, 2014 Testosterone CYP-250/PROP-20 mg, 10 Ml Syringe, Compounded Rx, Perry Drug Com... Lack of sterility assurance;All lots of sterile products compounded by the pharmacy that are with... Class II Perry Drug Inc.
Nov 7, 2014 2Ml HCG 10,000 U/ MB12 - 12,000 MCG/10 Ml Inj, 0.25ML (250IU), Rx, Perry Drug... Lack of sterility assurance;All lots of sterile products compounded by the pharmacy that are with... Class II Perry Drug Inc.
Nov 7, 2014 Cyclosporine 0.045 % Sol PF, 12 mL bottle, Rx, Perry Drug Compounding Pharmac... Lack of sterility assurance;All lots of sterile products compounded by the pharmacy that are with... Class II Perry Drug Inc.
Oct 24, 2014 Meropenem I.V. 1 g is supplied in 30 mL injection vials, RX only. Manufactur... Defective Container: Glass vials may crack due to low (thin) out of specification vial wall thick... Class II Hospira Inc.
Oct 14, 2014 Tri-mix #4 (Papaverine 30 mg, Phentolamine 1 mg, Prostaglandin-1 10 mcg/mL), ... Lack of Assurance of Sterility: A recent FDA inspection of Vann Healthcare Services facility reve... Class II Vann Healthcare Services Inc
Oct 14, 2014 Hydroxyprogesterone Caproate, 250 mg per mL, 5 mL vial, Rx, Vann Healthcare P... Lack of Assurance of Sterility: A recent FDA inspection of Vann Healthcare Services facility reve... Class II Vann Healthcare Services Inc
Oct 14, 2014 5% Dextrose and 0.9% Sodium Chloride Injection, USP, 1000 mL container, Rx O... Lack of Assurance of Sterility: Potential of punctures through the overwrap and primary container... Class II Hospira Inc.
Oct 14, 2014 0.45% Sodium Chloride Injection, USP, 1000 mL container, Rx Only, Manufacture... Lack of Assurance of Sterility: Potential of punctures through the overwrap and primary container... Class II Hospira Inc.
Oct 14, 2014 Sterile Water for Injection, USP, 1000 mL container, Rx Only, Manufactured by... Lack of Assurance of Sterility: Potential of punctures through the overwrap and primary container... Class II Hospira Inc.
Oct 14, 2014 0.9% Sodium Chloride Injection, USP, 1000 mL container, Rx Only, Manufactured... Lack of Assurance of Sterility: Potential of punctures through the overwrap and primary container... Class II Hospira Inc.
Oct 14, 2014 5% Dextrose Injection, USP, 1000 mL container, Rx Only, Manufactured by Hospi... Lack of Assurance of Sterility: Potential of punctures through the overwrap and primary container... Class II Hospira Inc.
Oct 14, 2014 Lidocaine 4% Syr (PF) Rx, 1 mL packaged in 3 mL syringes, Vann Healthcare Pha... Lack of Assurance of Sterility: A recent FDA inspection of Vann Healthcare Services facility reve... Class II Vann Healthcare Services Inc
Oct 14, 2014 5% Dextrose and 0.45% Sodium Chloride Injection, USP, 1000 mL container, Rx O... Lack of Assurance of Sterility: Potential of punctures through the overwrap and primary container... Class II Hospira Inc.
Oct 14, 2014 Lactated Ringer's Injection, USP, 1000 mL container, Rx Only, Manufactured by... Lack of Assurance of Sterility: Potential of punctures through the overwrap and primary container... Class II Hospira Inc.
Oct 14, 2014 Lactated Ringer's and 5% Dextrose Injection, USP; 1000 mL container, Rx Only,... Lack of Assurance of Sterility: Potential of punctures through the overwrap and primary container... Class II Hospira Inc.
Oct 14, 2014 Normosol-R Multiple Electrolytes Injection Type 1, USP, 1000 mL container, R... Lack of Assurance of Sterility: Potential of punctures through the overwrap and primary container... Class II Hospira Inc.
Oct 14, 2014 Epinephrine 1:1000, 0.15 mL packaged in 0.3 mL syringes, Rx, Vann Healthcare ... Lack of Assurance of Sterility: A recent FDA inspection of Vann Healthcare Services facility reve... Class II Vann Healthcare Services Inc
Oct 14, 2014 Normosol-R pH 7.4 Multiple Electrolytes Injection Type 1, USP, 1000 mL contai... Lack of Assurance of Sterility: Potential of punctures through the overwrap and primary container... Class II Hospira Inc.
Oct 14, 2014 Potassium Chloride in 5% Dextrose and 0.45% Sodium Chloride Injection, USP, 1... Lack of Assurance of Sterility: Potential of punctures through the overwrap and primary container... Class II Hospira Inc.
Oct 6, 2014 HYDROXYPROGESTERONE CAPROATE (SESAME OIL), 250mg/mL, injectable, 5 mL glass v... 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 CEFTAZIDIME, 2.25mg/0.1mL, Injectable, 0.2 mL plastic syringe, 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 PAPAVERINE/PHENTOLAMINE/PROSTAGLANDIN, 17.64mg/0.58mg/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 EPINEPHRINE/WATER, preservative free 1:1000, 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...
Oct 6, 2014 PROCAINE HCL (BUFF), 1%, injectable, 10 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 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...
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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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...

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.