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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.

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DateProductReasonClassFirm
May 22, 2014 Cefpodoxime Proxetil Tablets, USP, 200 mg, 20 Tablet Bottles, Rx Only. Manufa... Presence of Foreign Substance: Presence of stainless steel particles. Class II Sandoz, Inc
May 21, 2014 Vaseretic (enalapril maleate/hydrochlorothiazide) 10/25 mg Tablets, NDC 0187-... Labeling: Incorrect or Missing Package Insert: Product is packaged with the incorrect version of ... Class III Valeant Pharmaceuticals North America LLC
May 21, 2014 Vasotec (enalapril maleate) tablets, RX only, Manufactured by Valeant Pharmac... Labeling: Incorrect or Missing Package Insert: Product is packaged with the incorrect version of ... Class III Valeant Pharmaceuticals North America LLC
May 20, 2014 Mesalamine, U.S.P. [CAS 89-57-6] Cambrex Charles City, Inc. Charles City, IA ... Presence of Particulate Matter: Stainless steel in a chemical reactor dissolved into the API solu... Class II Cambrex Charles City Inc
May 20, 2014 Isoniazid Tablets, USP, 300 mg, Rx only, packaged in a) 100-count bottles, ND... Failed Dissolution Specifications: Stability lots cannot support dissolution past the 36 month ti... Class II West-Ward Pharmaceutical Corp.
May 16, 2014 Vancomycin Hydrochloride Capsules, USP, 250 mg. 20 Capsules on 2 x 10 Capsul... Subpotent Drug. Class II Actavis Inc
May 16, 2014 Labetalol Hydrochloride Injection, USP, 100 mg/20 mL (5 mg/mL), 20 mL Multido... Presence of Particulate Matter; metal embedded in the glass vial and visible particles floating i... Class II Hospira Inc.
May 16, 2014 ePHEDrine Sulfate Injection, USP 25 mg/5 mL (5 mg/mL) Single Use 5 mL Syring... Labeling: Label Error on Declared Strength; The outer light protective bags, where the ephedrine ... Class II US Compounding Inc
May 15, 2014 Pfizerpen (penicillin G) 24 MU/300 mL 0.9%NS, Trinity Care Solutions, 202-C S... Lack of Assurance of Sterility; All lots of sterile products compounded by the pharmacy within ex... Class II Franck's Lab Inc dba Trinity Care Solutions
May 15, 2014 Ambisome 285 mg/250 mL D5W, Trinity Care Solutions, 202-C SW 17th Street, Oca... Lack of Assurance of Sterility; All lots of sterile products compounded by the pharmacy within ex... Class II Franck's Lab Inc dba Trinity Care Solutions
May 15, 2014 Cefepime 1 gm/100 mL 0.9%NS, Trinity Care Solutions, 202-C SW 17th Street, Oc... Lack of Assurance of Sterility; All lots of sterile products compounded by the pharmacy within ex... Class II Franck's Lab Inc dba Trinity Care Solutions
May 15, 2014 Vancomycin 1.25 gm/250 mL 0.9%NS,Trinity Care Solutions, 202-C SW 17th Street... Lack of Assurance of Sterility; All lots of sterile products compounded by the pharmacy within ex... Class II Franck's Lab Inc dba Trinity Care Solutions
May 15, 2014 Vancomycin 750 mg/150mL D5W,Trinity Care Solutions, 202-C SW 17th Street, Oca... Lack of Assurance of Sterility; All lots of sterile products compounded by the pharmacy within ex... Class II Franck's Lab Inc dba Trinity Care Solutions
May 15, 2014 Ceftriaxone 2 gm/100 mL 0.9%NS, Trinity Care Solutions, 202-C SW 17th Street,... Lack of Assurance of Sterility; All lots of sterile products compounded by the pharmacy within ex... Class II Franck's Lab Inc dba Trinity Care Solutions
May 15, 2014 Cubicin 486 mg/100 mL 0.9%NS, Trinity Care Solutions, 202-C SW 17th Street, O... Lack of Assurance of Sterility; All lots of sterile products compounded by the pharmacy within ex... Class II Franck's Lab Inc dba Trinity Care Solutions
May 15, 2014 Vancomycin 750 mg/100 mL 0.9%NS, Trinity Care Solutions, 202-C SW 17th Street... Lack of Assurance of Sterility; All lots of sterile products compounded by the pharmacy within ex... Class II Franck's Lab Inc dba Trinity Care Solutions
May 15, 2014 Meropenem 1 gm/100 mL 0.9%NS, Trinity Care Solutions, 202-C SW 17th Street, O... Lack of Assurance of Sterility; All lots of sterile products compounded by the pharmacy within ex... Class II Franck's Lab Inc dba Trinity Care Solutions
May 15, 2014 Ceftriaxone 1 gm/50 mL D5W, Trinity Care Solutions, 202-C SW 17th Street, Oca... Lack of Assurance of Sterility; All lots of sterile products compounded by the pharmacy within ex... Class II Franck's Lab Inc dba Trinity Care Solutions
May 15, 2014 ANA Kit, Trinity Care Solutions, 202-C SW 17th Street, Ocala, FL 34471-5138, ... Lack of Assurance of Sterility; All lots of sterile products compounded by the pharmacy within ex... Class II Franck's Lab Inc dba Trinity Care Solutions
May 15, 2014 Cubicin 600 mg/100 mL 0.9%NS, Trinity Care Solutions, 202-C SW 17th Street, O... Lack of Assurance of Sterility; All lots of sterile products compounded by the pharmacy within ex... Class II Franck's Lab Inc dba Trinity Care Solutions
May 15, 2014 Impipenem/Cilastin (Primaxin) 500 mg/100 mL 0.9%NS, Trinity Care Solutions, 2... Lack of Assurance of Sterility; All lots of sterile products compounded by the pharmacy within ex... Class II Franck's Lab Inc dba Trinity Care Solutions
May 15, 2014 Normal Saline 10 mL/10 mL Syringe, Trinity Care Solutions, 202-C SW 17th Stre... Lack of Assurance of Sterility; All lots of sterile products compounded by the pharmacy within ex... Class II Franck's Lab Inc dba Trinity Care Solutions
May 15, 2014 Desferal 2.5 gm/14 mL Sterile Water, Trinity Care Solutions, 202-C SW 17th St... Lack of Assurance of Sterility; All lots of sterile products compounded by the pharmacy within ex... Class II Franck's Lab Inc dba Trinity Care Solutions
May 15, 2014 Levofloxacin 750 mg/250 mL D5W, Trinity Care Solutions, 202-C SW 17th Street,... Lack of Assurance of Sterility; All lots of sterile products compounded by the pharmacy within ex... Class II Franck's Lab Inc dba Trinity Care Solutions
May 15, 2014 Cubicin 444 mg/100 mL 0.9%NS, Trinity Care Solutions, 202-C SW 17th Street, O... Lack of Assurance of Sterility; All lots of sterile products compounded by the pharmacy within ex... Class II Franck's Lab Inc dba Trinity Care Solutions
May 15, 2014 Nafcillin 12 gm/300 mL, Trinity Care Solutions, 202-C SW 17th Street, Ocala, ... Lack of Assurance of Sterility; All lots of sterile products compounded by the pharmacy within ex... Class II Franck's Lab Inc dba Trinity Care Solutions
May 15, 2014 Cubicin 700 mg/100 mL 0.9%NS, Trinity Care Solutions, 202-C SW 17th Street, O... Lack of Assurance of Sterility; All lots of sterile products compounded by the pharmacy within ex... Class II Franck's Lab Inc dba Trinity Care Solutions
May 15, 2014 Cefepime 2 gm/100 mL D5W, Trinity Care Solutions, 202-C SW 17th Street, Ocala... Lack of Assurance of Sterility; All lots of sterile products compounded by the pharmacy within ex... Class II Franck's Lab Inc dba Trinity Care Solutions
May 15, 2014 Cubicin 543 mg/100 mL 0.9%NS, Trinity Care Solutions, 202-C SW 17th Street, O... Lack of Assurance of Sterility; All lots of sterile products compounded by the pharmacy within ex... Class II Franck's Lab Inc dba Trinity Care Solutions
May 15, 2014 Desferal 2 gm/8 mL Sterile Water, Trinity Care Solutions, 202-C SW 17th Stree... Lack of Assurance of Sterility; All lots of sterile products compounded by the pharmacy within ex... Class II Franck's Lab Inc dba Trinity Care Solutions
May 15, 2014 Unasyn (ampicillin/sulbactam) 1.5 gm/100 mL 0.9%NS, Trinity Care Solutions, 2... Lack of Assurance of Sterility; All lots of sterile products compounded by the pharmacy within ex... Class II Franck's Lab Inc dba Trinity Care Solutions
May 15, 2014 Invanz (ertapenem)1 gm/100 mL 0.9%NS, Trinity Care Solutions, 202-C SW 17th ... Lack of Assurance of Sterility; All lots of sterile products compounded by the pharmacy within ex... Class II Franck's Lab Inc dba Trinity Care Solutions
May 15, 2014 Tobramycin 300 mg/7.5 mL Syringe (for Neb), Trinity Care Solutions, 202-C SW ... Lack of Assurance of Sterility; All lots of sterile products compounded by the pharmacy within ex... Class II Franck's Lab Inc dba Trinity Care Solutions
May 15, 2014 Vancomycin 1.25 gm/100 mL 0.9%NS, Trinity Care Solutions, 202-C SW 17th Stree... Lack of Assurance of Sterility; All lots of sterile products compounded by the pharmacy within ex... Class II Franck's Lab Inc dba Trinity Care Solutions
May 15, 2014 Cefazolin 1 gm/100 mL 0.9%NS, Trinity Care Solutions, 202-C SW 17th Street, O... Lack of Assurance of Sterility; All lots of sterile products compounded by the pharmacy within ex... Class II Franck's Lab Inc dba Trinity Care Solutions
May 15, 2014 Vancomycin 1 gm/100 mL 0.9%NS,Trinity Care Solutions, 202-C SW 17th Street, O... Lack of Assurance of Sterility; All lots of sterile products compounded by the pharmacy within ex... Class II Franck's Lab Inc dba Trinity Care Solutions
May 15, 2014 Cefepime 2 gm/100 mL 0.9%NS, Trinity Care Solutions, 202-C SW 17th Street, Oc... Lack of Assurance of Sterility; All lots of sterile products compounded by the pharmacy within ex... Class II Franck's Lab Inc dba Trinity Care Solutions
May 15, 2014 Ceftriaxone 2 gm/100 mL D5W, Trinity Care Solutions, 202-C SW 17th Street, Oc... Lack of Assurance of Sterility; All lots of sterile products compounded by the pharmacy within ex... Class II Franck's Lab Inc dba Trinity Care Solutions
May 14, 2014 Oasis TEARS, Lubricant Eye Drops, 10mL/0.3 fl. oz. Bottle, OTC Only. Distribu... Labeling: Missing Label; The label on the immediate bottle is missing. Class III Oasis Medical Inc
May 12, 2014 Polidocanol 1% Solution for Injection, each mL contains Polidocanol (Laureth ... Lack of Assurance of Sterility: Lack of sterility assurance in compounded aseptically filled inje... Class II John W Hollis Inc
May 12, 2014 Polidocanol 0.5% Solution for Injection, Polidocanol (Laureth 9) 5mg, 50 mL,... Lack of Assurance of Sterility: Lack of sterility assurance in compounded aseptically filled inje... Class II John W Hollis Inc
May 12, 2014 Bystolic (nebivolol), 20 mg/tablet, 30 tablets per bottle, Rx only, Licensed ... Failed Dissolution Specifications: One lot of product is being voluntarily recalled because disso... Class II Forest Pharmaceuticals Inc
May 12, 2014 Mannitol 5% Solution for injection, Mannitol 50 mg, also contains Sterile Wat... Lack of Assurance of Sterility: Lack of sterility assurance in compounded aseptically filled inje... Class II John W Hollis Inc
May 12, 2014 Papaverine HCl 30 mg, Phentolamine Mesylate 2 mg, Alprostadil 40 mcg, a) 5 mL... Lack of Assurance of Sterility: Lack of sterility assurance in compounded aseptically filled inje... Class II John W Hollis Inc
May 12, 2014 Papaverine HCl 30 mg, Phentolamine Mesylate 2 mg, Alprostadil 20 mcg, 10 mL, ... Lack of Assurance of Sterility: Lack of sterility assurance in compounded aseptically filled inje... Class II John W Hollis Inc
May 12, 2014 COUMADIN FOR INJECTION (Warfarin Sodium for Injection, USP 5 mg Single-Use Vi... Presence of Particulate Matter: particulate matter identified as metallic-like and non-metallic c... Class I Bristol-Meyers Squibb
May 12, 2014 Levocarnitine Solution for injection, l-Carnitine 50 mg, Also Contains Steril... Lack of Assurance of Sterility: Lack of sterility assurance in compounded aseptically filled inje... Class II John W Hollis Inc
May 12, 2014 PYRIDOXINE HCL, Pyridoxine HCl 100mg, Also Contans: Benzyl Alcohol, Sodium Ch... Lack of Assurance of Sterility: Lack of sterility assurance in compounded aseptically filled inje... Class II John W Hollis Inc
May 12, 2014 Liver Derivative Complex for injection, each mL contains: Liver Derivative Co... Lack of Assurance of Sterility: Lack of sterility assurance in compounded aseptically filled inje... Class II John W Hollis Inc
May 12, 2014 Papaverine HCl 30 mg, Phentolamine Mesylate 1 mg, Alprostadil 20 mcg, a) 5 mL... Lack of Assurance of Sterility: Lack of sterility assurance in compounded aseptically filled inje... Class II John W Hollis 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.