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 11,081–11,100 of 17,974 drug recalls

Drug Recall Terminated Historical recordClass II

Mimvey Lo (estradiol and norethindrone acetate tablets USP), 0.5 mg/0.1 mg, 28 tablets per blister card (NDC 0093-5454-18), packaged in 3 blister cards per carton (NDC 0093-5454-62), Rx only, Manufactured By: Barr Laboratories, Inc., Pomona, NY 10970; Manufactured For: Teva Pharmaceuticals USA, Sellersville, PA 18960.

by Teva Pharmaceuticals USA

Reason
Failed Impurities/Degradation Specifications: out of specification test results for the norethindrone impurity.
Recall initiated
February 2, 2017
Reported by FDA
February 22, 2017
Distribution
Nationwide in the United States

View recall →

Drug Recall Terminated Historical recordClass II

Lisinopril tablets, 5 mg, 1000-count bottle, Rx only, Manufactured for Accord Healthcare, Inc., Durham, NC 27703, NDC 16729-376-17

by ACCORD HEALTHCARE, INC.

Reason
Failed tablet/capsule specification: missing break line on the 5mg tablet.
Recall initiated
December 20, 2016
Reported by FDA
February 22, 2017
Distribution
U.S. Nationwide and Puerto Rico

View recall →

Drug Recall Terminated Historical recordClass III

Taclonex (calcipotriene and betamethasone dipropionate) Topical Suspension, 0.005%/0.064%, packaged in (a) 60 g (NDC 50222-501-06), and (b)120 g (50222-501-66) tubes, Rx Only, Manufactured by: LEO Laboratories Ltd., 285 Cashel Road, Dublin 12 Ireland, Distributed by: LEO Pharma Inc. 1 Sylvan Way, Parsippany, NJ 07054.

by LEO PHARMA INC

Reason
Labeling: Incorrect or missing package insert: the affected product was packaged with an out-of-date package insert (PI) dated February 2014.
Recall initiated
January 16, 2017
Reported by FDA
February 22, 2017
Distribution
Nationwide within US

View recall →

Drug Recall Terminated Historical recordClass II

Glipizide extended-release tablets, 2.5mg, 30-count bottle, Rx Only, Manufactured By Patheon Pharmaceuticals Inc Cincinnati OH 45237 USA, NDC 0591-0900-30, UPC 3-0591090030-4

by Actavis Inc

Reason
Failed Dissolution Specifications. Above out of specification for dissolution rate observed at the 10 hour testing point.
Recall initiated
January 30, 2017
Reported by FDA
February 22, 2017
Distribution
Nationwide in US

View recall →

Drug Recall Terminated Historical recordClass II

Venlafaxine Hydrochloride extended release capsules, 37.5 mg, 30-count bottles, Rx Only, Manufactured for: Aurobindo Pharma USA, Inc. 2400 Route 130 North, Dayton, NJ 08810 Manufactured by: Aurobindo Pharma Limited Hyderabad-500 072 India, NDC 65862-527-30

by Aurobindo Pharma USA Inc

Reason
Failed Tablet/Capsule Specifications: Some bottles contain punctured, and/or clumped/melted capsules.
Recall initiated
December 22, 2016
Reported by FDA
February 22, 2017
Distribution
Nationwide in the US

View recall →

Drug Recall Terminated Historical recordClass I

SLIMFIT X capsules, packaged in a 60-cont bottle

by Jersey Shore Supplements, LLC

Reason
Marketed without an approved NDA/ANDA: Product contains undeclared sibutramine and desmethylsibutramine.
Recall initiated
December 9, 2016
Reported by FDA
February 22, 2017
Distribution
New Jersey and Maryland.

View recall →

Drug Recall Terminated Historical recordClass I

MegaJex Herbal Supplement, Maximum Formula for Men, Fast acting, Increase Stamina, 20 capsules, MS Bionics, Gardena, CA

by MS Bionic

Reason
Marketed without an Approved NDA/ANDA; product contains sildenafil and tadalafil which are active pharmaceutical ingredients in FDA approved drugs used to treat erectile dysfunction (ED)
Recall initiated
November 30, 2016
Reported by FDA
February 22, 2017
Distribution
CA

View recall →

Drug Recall Terminated Historical recordClass III

Aripiprazole Tablets, 2 mg, 30-count bottle, Rx only, Manufactured by: Apotex Inc., Toronto, Ontario, Canada, M9L 1T9; Manufactured for: Apotex Corp., Weston, Florida 33326, NDC 60505-3075-3.

by Apotex Inc.

Reason
Superpotent Drug: Product may not meet specifications throughout shelf life.
Recall initiated
December 19, 2016
Reported by FDA
February 15, 2017
Distribution
Nationwide in the USA

View recall →

Drug Recall Terminated Historical recordClass III

Pantoprazole Sodium for Injection, 40mg per vial, Single-dose vial, Rx only, Mfd. in India for: Auromedics Pharma LLC 6 Wheeling Road, Dayton, NJ 08810, NDC 55150-202-00

by Aurobindo Pharma USA Inc

Reason
Discoloration: Some vials were found to contain powder with a yellowish-brownish appearance.
Recall initiated
December 16, 2016
Reported by FDA
February 15, 2017
Distribution
Nationwide in US

View recall →

Drug Recall Terminated Historical recordClass II

Potassium Chloride Oral Solution, USP, 10%, 20 mEq per 15 mL, packaged in 15 mL unit dose cups (NDC 66689-047-01), 50 unit dose cups per case (NDC 66689-047-50), Rx only, Xact Dose, Manufactured by VistaPharm, Largo, FL 33771.

by VistaPharm, Inc.

Reason
Defective Container: Leakage of unit dose cups that may occur at the seal.
Recall initiated
January 18, 2017
Reported by FDA
February 15, 2017
Distribution
Domestic: AL, AZ, CA, CO, CT, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MI, MN, MO, MS, NC, NE, NH, NJ, NM, NY, OH, OK, OR, PA, TN, TX, UT, VA, WA WI, & WV.

View recall →

Drug Recall Terminated Historical recordClass III

Olanzapine tablets, USP, 2.5 mg, packaged in a 30-count bottle, Rx only, Mfd: By: Dr. Reddy's Laboratories Limited, Bachupally, India, NDC 55111-163-30

by Dr. Reddy's Laboratories, Inc.

Reason
Failed impurities/degradation specifications: due to out-of-specification result for the Related Substance Compound C (Impurity 6 - N-Oxide at the 18 month stability station.
Recall initiated
October 13, 2016
Reported by FDA
February 15, 2017
Distribution
US Nationwide

View recall →

Drug Recall Terminated Historical recordClass II

Methadone Hydrochloride Oral Concentrate, USP 5 mg/5 mL C-II, 500 mL, 6 bottles per case, Rx only, Manufactured by VistaPharm, Largo, FL 33771, NDC No. 66689-711-16.

by VistaPharm, Inc.

Reason
CGMP Deviations: Purified water used to manufacture the drug products may have been contaminated with Burkholderia cepacia.
Recall initiated
January 18, 2017
Reported by FDA
February 8, 2017
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass II

Methadone Hydrochloride Oral Concentrate, USP 10 mg/mL C-II (Sugar Free), 1 liter (1000 mL), 4 bottles per case, Rx only, Manufactured by VistaPharm, Largo, FL 33771, NDC No. 66689-695-79.

by VistaPharm, Inc.

Reason
CGMP Deviations: Purified water used to manufacture the drug products may have been contaminated with Burkholderia cepacia.
Recall initiated
January 18, 2017
Reported by FDA
February 8, 2017
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass II

Methadone Hydrochloride Oral Concentrate, USP 10 mg/mL C-II, a.) 1 fl. oz. (30 mL), 12 bottles per case (NDC No. 66689-695-30), b). 1 liter (1000 mL), 4 bottles per case, (NDC No. 66689-695-79), Rx only, Manufactured by VistaPharm, Largo, FL 33771.

by VistaPharm, Inc.

Reason
CGMP Deviations: Purified water used to manufacture the drug products may have been contaminated with Burkholderia cepacia.
Recall initiated
January 18, 2017
Reported by FDA
February 8, 2017
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass II

Oxycodone Hydrochloride Oral Solution, USP 5 mg/5 mL, a). 5 mL, 50 unit dose cups of 5 mL per case (NDC No. 66689-401-50), b). 500 mL, 12 bottles per case (NDC No. 66689-403-16), Rx only, Manufactured by VistaPharm, Largo, FL 33771.

by VistaPharm, Inc.

Reason
CGMP Deviations: Purified water used to manufacture the drug products may have been contaminated with Burkholderia cepacia.
Recall initiated
January 18, 2017
Reported by FDA
February 8, 2017
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass II

Lactulose Solution, USP 10 g/15 mL, 50 unit dose cups of 15 mL per case, Rx only, Manufactured by VistaPharm, Largo, FL 33771, NDC No. 66689-039-50.

by VistaPharm, Inc.

Reason
CGMP Deviations: Purified water used to manufacture the drug products may have been contaminated with Burkholderia cepacia.
Recall initiated
January 18, 2017
Reported by FDA
February 8, 2017
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass II

Lactulose Solution, USP 20 g/30 mL, 50 unit dose cups of 30 mL per case, Rx only, Manufactured by VistaPharm, Largo, FL 33771, NDC No. 66689-038-50.

by VistaPharm, Inc.

Reason
CGMP Deviations: Purified water used to manufacture the drug products may have been contaminated with Burkholderia cepacia.
Recall initiated
January 18, 2017
Reported by FDA
February 8, 2017
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass II

Nystatin Oral Suspension, USP 500,000 Units/5 mL, a). 50 unit dose cups of 5 mL per case (NDC No. 66689-037-50), b). 100 unit dose cups of 5 mL per case (NDC 66689-037-99), Rx only, Manufactured by VistaPharm, Largo, FL 33771.

by VistaPharm, Inc.

Reason
CGMP Deviations: Purified water used to manufacture the drug products may have been contaminated with Burkholderia cepacia.
Recall initiated
January 18, 2017
Reported by FDA
February 8, 2017
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass II

Phenytoin Oral Suspension, USP 100 mg/ 4 mL, 50 unit dose cups of 4 mL per case., Rx only, Manufactured by VistaPharm, Largo, FL 33771, NDC No. 66689-036-50.

by VistaPharm, Inc.

Reason
CGMP Deviations: Purified water used to manufacture the drug products may have been contaminated with Burkholderia cepacia.
Recall initiated
January 18, 2017
Reported by FDA
February 8, 2017
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass II

Metoclopramide Oral Solution, USP 10 mg/ 10 mL, 50 unit dose cups of 10 mL per case, Rx only, Manufactured by VistaPharm, Largo, FL 33771, NDC No. 66689-031-50.

by VistaPharm, Inc.

Reason
CGMP Deviations: Purified water used to manufacture the drug products may have been contaminated with Burkholderia cepacia.
Recall initiated
January 18, 2017
Reported by FDA
February 8, 2017
Distribution
Nationwide

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.