Skip to main content
Get Alerts

FDA Drug Recalls

Every FDA drug enforcement recall Public Health Trace has on record, republished from openFDA's official drug enforcement database. See Health Alerts for current, active recalls alongside outbreaks and advisories.

Drug recall information is sourced from the FDA's structured openFDA Enforcement Reports. Newly announced recalls may appear on FDA.gov before they become available in the structured dataset. See Methodology for how Public Health Trace imports and refreshes this data.

Filters
Recall details
Location
Date range
Clear filters

Showing 12,061–12,080 of 17,974 drug recalls

Drug Recall Terminated Historical recordClass III

Dicloxacillin Sodium Capsules USP, 500mg, Rx Only, 100 Capsule bottle, Manufactured in Austria by Sandoz Gmbh, Distributed by Sandoz Inc. , Princeton, NJ 08540, Product of Spain, NDC 0781-2258-01

by Sandoz, Inc

Reason
Failed Impurities/Degradation Specifications:Out of specification result for a known impurity obtained during testing.
Recall initiated
May 2, 2016
Reported by FDA
June 29, 2016
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass III

Dicloxacillin Sodium Capsules, USP 250mg, Rx Only, 100 Capsule Bottle, Manufactured in Austria by Sandoz Gmbh, Distributed by Sandoz Inc., Princeton, NJ 08540, Product of Spain, NDC 0781-2248-01

by Sandoz, Inc

Reason
Failed Impurities/Degradation Specifications:Out of specification result for a known impurity obtained during testing.
Recall initiated
May 2, 2016
Reported by FDA
June 29, 2016
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass III

Hyoscyamine Sulfate Sublingual Tablets, 0.125 mg, packaged in 100-count bottles, Rx only, Manufactured for: Virtus Pharmaceuticals OPCO II, LLC. Nashville, TN 37217. NDC 76439-0309-10

by Virtus Pharmaceuticals, Llc

Reason
Chemical Contamination: Bottles may contain broken dessicants
Recall initiated
May 13, 2016
Reported by FDA
June 29, 2016
Distribution
Nationwide & Puerto Rico.

View recall →

Drug Recall Terminated Historical recordClass II

1% Clotrimazol cream, 30 mg tube, UPC 501318644335

by Profarma Distributors LLC

Reason
CGMP Deviations
Recall initiated
May 11, 2016
Reported by FDA
June 29, 2016
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass II

VERMOX Tablets 500 mg, 1-count box, UPC 501109900596

by Profarma Distributors LLC

Reason
CGMP Deviations
Recall initiated
May 11, 2016
Reported by FDA
June 29, 2016
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass II

VERMOX Tablets 100 mg; 6-count box, UPC 7501109900619

by Profarma Distributors LLC

Reason
CGMP Deviations
Recall initiated
May 11, 2016
Reported by FDA
June 29, 2016
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass II

tabcin NOCHE; Capsules,12-count box, UPC 501008485033

by Profarma Distributors LLC

Reason
CGMP Deviations
Recall initiated
May 11, 2016
Reported by FDA
June 29, 2016
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass II

tabcin ACTIVE M.R. Capsules, 12-count box , UPC 7501008485057

by Profarma Distributors LLC

Reason
CGMP Deviations
Recall initiated
May 11, 2016
Reported by FDA
June 29, 2016
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass III

Pramipexole Dihydrochloride Extended Release Tablets, 0.375 mg, Rx Only, 30 count bottles, Manufactured By: Par Pharmaceutical Companies, Inc., Chestnut Ridge, NY 10977, NDC 10370-251-11

by Par Pharmaceutical

Reason
Failed Impurities/Degradation Specifications: Par Pharmaceutical is recalling Pramipexole Dihydrochloride Extended Release tablets because it contains a known product impurity above currently approved specification levels.
Recall initiated
May 28, 2016
Reported by FDA
June 22, 2016
Distribution
Nationwide and Puerto Rico.

View recall →

Drug Recall Terminated Historical recordClass II

Sensorcaine- MPF (Bupivacaine HCI Injection, USP), 0.75% in a 30 mL Single Dose Vial, Rx only, Fresenius Kabi USA LLC, Lake Zurich, IL 60047, NDC 63323-472-37

by Fresenius Kabi USA, LLC

Reason
Presence of Particulate Matter: Glass particulate found in sterile injectable product
Recall initiated
April 25, 2016
Reported by FDA
June 22, 2016
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass III

Lisinopril Tablets USP, 30 mg, 100-count bottle, Rx Only, Manufactured by Sandoz Inc., Princeton, NJ 08540, NDC 0185-0630-01

by Sandoz Inc

Reason
Labeling: Incorrect or Missing Package Insert
Recall initiated
May 25, 2016
Reported by FDA
June 22, 2016
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass III

Chlordiazepoxide HCl/Clidinium Bromide capsules, 5 /2.5 mg, 100-count bottle, Rx Only, Manufactured in Canada by: Valeant Pharmaceuticals International, Inc., Steinbach, MB R5G 1Z7 Canada; Manufactured for: Oceanside Pharmaceuticals, a division of Valeant Pharmaceuticals North America LLC, Bridgewater, NJ 08807, NDC 68682-409-10.

by Valeant Pharmaceuticals North America LLC

Reason
Failed Impurities/Degradation Specifications
Recall initiated
April 18, 2015
Reported by FDA
June 22, 2016
Distribution
Nationwide and Puerto Rico

View recall →

Drug Recall Terminated Historical recordClass III

Librax (5 mg chlordiazepoxide HCl and 2.5 mg clidinium bromide) capsules, 100-count bottle, Rx Only, Manufactured in Canada by: Valeant Pharmaceuticals International, Inc., Steinbach, MB R5G 1Z7 Canada; Manufactured for: Valeant Pharmaceuticals North America LLC, Bridgewater, NJ 08807, NDC 0187-4100-10.

by Valeant Pharmaceuticals North America LLC

Reason
Failed Impurities/Degradation Specifications
Recall initiated
April 18, 2015
Reported by FDA
June 22, 2016
Distribution
Nationwide and Puerto Rico

View recall →

Drug Recall Terminated Historical recordClass II

Vancomycin Hydrochloride for Injection, USP, 10 g, 100 mL vial, Rx only, Hospira, Lake Forest, IL, NDC 0409-6510-01

by Hospira Inc.

Reason
Presence of Particulate Matter: Cardboard
Recall initiated
May 6, 2016
Reported by FDA
June 22, 2016
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass III

Lodrane D (Brompheniramine maleate 4 mg and Pseudoephedrine HCl 60 mg) Capsules, 60-count bottles, Distributed by: Valeant Pharmaceuticals North America LLC, Bridgewater, NJ 08807, UPC 0 00950 86006 8.

by Valeant Pharmaceuticals North America LLC

Reason
Labeling: Not Elsewhere Classified: correctly labeled bottles were packaged in cartons that were mislabeled with an incorrect active ingredient, phenylephrine rather than pseudoephedrine, on the carton face and carton top.
Recall initiated
May 23, 2016
Reported by FDA
June 22, 2016
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass III

Doxycycline, USP Capsules 40 mg, Packaged in 30 ct Bottles, Rx Only. Marketed by: Prasco Laboratories, Mason, OH 45040 USA, Manufactured by: Catalent Pharma Solutions, LLC, Winchester, Kentucky 40391. NDC: 66993-815-30.

by Galderma Laboratories, L.P.

Reason
Labeling: Incorrect Or Missing Lot and/or Exp Date: Some expiries and lot numbers are missing.
Recall initiated
May 19, 2016
Reported by FDA
June 22, 2016
Distribution
U.S. Nationwide

View recall →

Drug Recall Terminated Historical recordClass II

Nitrofurantoin Oral Suspension, USP, 25 mg/5 mL, FOR ORAL USE ONLY, URINARY TRACT ANTIBACTERIAL, Rx Only , 240 mL bottle, Dist. by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Mfg. by: Sun Pharmaceutical Industries, Inc., Bryan, Ohio 43506, NDC 57664-239-32

by Nostrum Laboratories, Inc.

Reason
Failed Dissolution Specifications
Recall initiated
May 23, 2016
Reported by FDA
June 22, 2016
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass III

Hectorol (doxercalciferol injection) 2 mcg/1mL, Rx only, Manufactured by: Genzyme Biosurgery Corporation 500 Kendall Street, Cambridge, MA 02142, NDC 58468-0126-1

by Genzyme Corporation / Genzyme Biosurgery

Reason
Labeling: Wrong barcode. An incorrect bar code was noted on the vial label of Hectorol 2 mcg/1mL vial.
Recall initiated
April 27, 2016
Reported by FDA
June 22, 2016
Distribution
MI, PA & NJ

View recall →

Drug Recall Terminated Historical recordClass II

TRI-MIX # 5, packaged in 5 mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121

by Well Care Compounding Pharmacy

Reason
Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility.
Recall initiated
May 17, 2016
Reported by FDA
June 15, 2016
Distribution
NV

View recall →

Drug Recall Terminated Historical recordClass II

M.I.C. /MB12/B6/DEXPLAN/L-CARN, 25MG/50MG/25MG/10MG/10MG/ML, packaged in 5mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121

by Well Care Compounding Pharmacy

Reason
Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility.
Recall initiated
May 17, 2016
Reported by FDA
June 15, 2016
Distribution
NV

View recall →

Data last updated:

This information is republished from FDA's Recall Enterprise System through openFDA. Public Health Trace does not verify or supplement it, is not affiliated with the FDA, and does not provide medical advice -- always follow the guidance of your pharmacist, physician, or the recalling company for any medication you take. Read the full medical disclaimer.