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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.

Clear
DateProductReasonClassFirm
Nov 7, 2014 Testosterone Cyp 200 mg/mL Sesame Inj., 4Ml Syringes, Compounded Rx, Perry Dr... 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 Low Dose 10 IU / 0.1 mL, 5 Ml vials, Compounded Rx, Perry Drug Compoundin... Lack of sterility assurance;All lots of sterile products compounded by the pharmacy that are with... Class II Perry Drug Inc.
Nov 7, 2014 Phenylephrine HCl (100 mcg/mL syr) in 0.9% NaCl 1 mg / 10 mL, 3Ml Syringes, C... 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 200 IU/mL Injection, 30Ml, 10 mL vials, Compounded Rx, Perry Drug Compoun... 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 Unit PF Inject, 1mL Syringe, Compounded Rx, Perry Drug Compoundi... Lack of sterility assurance;All lots of sterile products compounded by the pharmacy that are with... Class II Perry Drug Inc.
Nov 7, 2014 Leuprolide 50 mcg/0.1 mL Micro Lupron Kit, 5Ml, 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 Methyl B12 25 mg/mL Inj., 10 Syringes, 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 HCG-20,000 U/2 mL Vial, Compounded Rx, Perry Drug Compounding Pharmacy, Overl... Lack of sterility assurance;All lots of sterile products compounded by the pharmacy that are with... Class II Perry Drug Inc.
Nov 3, 2014 Forever Beautiful INFINITY, capsules, 300mg in 60-count bottles, 900 Commonwe... Marketed Without an Approved NDA/ANDA: FDA analysis found product to contain sibutramine and phen... Class I REFA Enterprises, LLC
Nov 3, 2014 Forever Beautiful BEE POLLEN, capsules, 250mg in 60-count bottles, 900 Common... Marketed Without an Approved NDA/ANDA: FDA analysis found product to contain sibutramine and phen... Class I REFA Enterprises, LLC
Oct 30, 2014 Heparin Sodium in 0.9% Sodium Chloride Injection, 1000 USP Heparin Units, 500... Subpotent Drug: Heparin raw material was found to have low potency Class II Baxter Healthcare Corp.
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 24, 2014 Scrub Care Chlorhexidine Gluconate Solution, 4% Surgical Hand Scrub, OTC, Car... Does Not Meet Monograph: Chlorhexidine Gluconate Surgical Scrub Brush is being recalled due to h... Class III CareFusion 213, LLC
Oct 22, 2014 Mercaptopurine Tablets, USP 50mg, a) 60-count bottle (NDC 49884-922-02), b) ... Failed Dissolution Specifications: Product found to be out of specification (OOS) during stabilit... Class II Prometheus Laboratories Inc.
Oct 21, 2014 Carbamazepine Tablets USP, 200 mg, 1000 Tablets per Bottle, Rx only, Manufact... Marketed without an Approved NDA/ANDA: One lot was on hold-pending release status when it was err... Class III Taro Pharmaceuticals U.S.A., Inc.
Oct 20, 2014 Z-COTE HP 1 TRANSPARENT ZINC OXIDE, Zinc Oxide (and) Triethoxycaprylylsilane,... cGMP Deviation; The incorrect amount of a raw material was added during the manufacture of two lo... Class III Nanophase Technologies Corporation
Oct 17, 2014 Gabapentin Capsules, USP 300 mg, 100-count bottles, Rx only, Manufactured for... Failed Tablet/Capsule Specifications: Complaints of empty capsules received. Class II Aurobindo Pharma USA Inc
Oct 17, 2014 Obagi Nu-Derm Clear, AM PM 3, Skin Bleaching and Corrector Cream, Hydroquinon... Labeling: Label Mix-Up; Containers of the Obagi Nu-Derm Clear pre-labeled bottles were inadverten... Class II Obagi Medical Products
Oct 16, 2014 Candesartan Cilexetil Tablets, 8 mg, 30-count bottle, Rx Only, Manufactured b... Failed Impurities/Degradation Specifications: Out of specification (OOS) results were observed fo... Class III Apotex Inc.
Oct 16, 2014 Candesartan Cilexetil Tablets, 16 mg, a) 30-count bottle (NDC 60505-3620-3) b... Failed Impurities/Degradation Specifications: Out of specification (OOS) results were observed fo... Class III Apotex Inc.
Oct 16, 2014 Cyproheptadine HCl Syrup (Cyproheptadine HCl Oral Solution, USP) 4mg/10 mL, R... Failed Impurities/Degradation Specifications : Out-of-specification result for an unidentified im... Class II Pharmaceutical Associates Inc
Oct 16, 2014 Candesartan Cilexetil Tablets, 32 mg, a) 30-count bottle (NDC 60505-3621-3) b... Failed Impurities/Degradation Specifications: Out of specification (OOS) results were observed fo... Class III Apotex Inc.
Oct 16, 2014 Candesartan Cilexetil Tablets, 4 mg, 30-count bottle, Rx Only, Manufactured b... Failed Impurities/Degradation Specifications: Out of specification (OOS) results were observed fo... Class III Apotex Inc.
Oct 16, 2014 1% LIDOCAINE HCl Injection, USP, 10 mg/mL, 30 mL Single-dose, Preservative-Fr... Presence of particulate matter: A returned customer sample was evaluated and found to have human ... Class I 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 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 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 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 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 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 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 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 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 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 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 0.45% 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 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 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 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 10, 2014 TORISEL Kit (temsirolimus) injection, 25 mg/mL, 1 vial of TORISEL 25 mg/mL an... Crystallization: Impurities in a raw material used to manufacture the diluent can cause the forma... Class III Pfizer Inc.
Oct 10, 2014 Assured Naproxen Sodium Tablets, USP 220 mg., 15 count bottle, Repackaged by ... Correct Labeled Product Mispacked; correct labeled bottles of Assured Ibuprofen softgels were pac... Class II Contract Packaging Resources Inc.
Oct 10, 2014 MethylPREDNISolone Tablets, USP, 4 mg, 100 unit dose blisters, Packaged and D... Subpotent; 6 month stability time point Class III American Health Packaging
Oct 9, 2014 GLIMEPIRIDE TABLETS, USP 2 mg, a)100 count bottle, (NDC 42571-101-01), b) 50... Failed Stability Specifications: Micro Labs is recalling two lots due to out of specification res... Class II Micro Labs Usa, Inc ...
Oct 8, 2014 DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFAT... Failed Impurities/Degradation Specifications: Out of specification for unknown impurities. Class II Teva Pharmaceuticals USA
Oct 7, 2014 ZEE Aspirin 325mg - 24 tablets in single dose packets, OTC, Manufactured for ... Incorrect/Undeclared Excipients: ZEE Medical is recalling ZEE Aspirin due to the incorrect listin... Class II Zee Medical Products Inc
Oct 6, 2014 SODIUM CHLORIDE INHALATION, 7%, Solution for inhalation, 3 mL plastic 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 PAPAVERINE HCL/PHENTOLAMINE/ALPROSTADIL, 21.82mg/0.91mg/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 AVASTIN, 1.25mg/0.5mL, injectable, 0.05 mL plastic syringe, RX, Creative Comp... 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, 500 mg Sterile Powder per Flipto... Temperature Abuse: Products experienced uncontrolled temperature excursions during transit. Class II Hospira Inc.
Oct 6, 2014 GENTAMICIN SULFATE, 100mg/1000mL, solution for irrigation, 400 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...

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.