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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.

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Showing 11,121–11,140 of 17,974 drug recalls

Drug Recall Terminated Historical recordClass III

DEXAMETHASONE ELIXIR, USP, 0.5 mg/5 mL, 8 fl.oz., Rx only, Manufactured for: QUALITEST PHARMACEUTICALS, HUNTSVILLE, AL, NDC 0603-1147-56

by Vintage Pharmaceuticals LLC dba Qualitest Pharmaceuticals

Reason
Failed Impurities/ Degradation Specifications
Recall initiated
January 16, 2017
Reported by FDA
February 1, 2017
Distribution
Nationwide

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Drug Recall Terminated Historical recordClass II

Furosemide Tablets USP, 20 mg, 1000 count bottles, Rx only, Roxane Laboratories, Inc., Columbus, Ohio 43216, NDC 0054-4297-31.

by Roxane Laboratories, Inc.

Reason
Failed Tablet/Capsule Specifications: An unusually thick tablet was reported through a complaint.
Recall initiated
December 22, 2016
Reported by FDA
February 1, 2017
Distribution
Nationwide in the USA

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Drug Recall Terminated Historical recordClass III

HCG (Chorionic Gonadotropin Lyopholized) II, 1000 unit vial, Rx only, Prepared by Town & Country, Compounding & Consultation Services, 106 Prospect St - 1st FL, Ridgewood, NJ 07459

by Town and Country Compounding and Consultation Services, LLC

Reason
Subpotent Drug: due to failed potency results of 74% (spec. 80-125%).
Recall initiated
October 18, 2016
Reported by FDA
January 25, 2017
Distribution
Nationwide

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Drug Recall Terminated Historical recordClass III

Donepezil Hydrochloride Tablets, 10 mg, packaged in a) 30-count bottles (NDC 0781-5275-31) and b) 1000-count bottles (NDC 0781-5275-10), Rx only, Manufactured in India by Sandoz Private Ltd for Sandoz Inc., Princeton, NJ 08540.

by Sandoz Inc

Reason
Subpotent Drug: out of specification results for assay test.
Recall initiated
December 13, 2016
Reported by FDA
January 25, 2017
Distribution
Nationwide in the USA

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Drug Recall Terminated Historical recordClass II

Clindamycin Phosphate and Benzoyl Peroxide Gel, 1.2%/5%, 45 g tubes, Rx Only, Manufactured by Perrigo, Yeruham, Israel, Distributed by Perrigo, Allegan, MI --- NDC 45802-736-84, UPC 345802736840

by L. Perrigo Company

Reason
Microbial Contamination of Non-Sterile Product; small number of tubes may include the presence of mold on the cap
Recall initiated
December 28, 2016
Reported by FDA
January 25, 2017
Distribution
Nationwide

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Drug Recall Terminated Historical recordClass III

Novacort Gel Sample Packets (2% hydrocortisone acetate, 1% pramoxine HCl), 10-count Carton of 1.0 g sample packets), NDC 69646-704-38 (10 ct. Carton of 1gm samples) / NDC 69646-704-01 (Individual 1gm Samples within Carton), Rx Only, Novum Pharma LLC, Chicago, IL 60654

by Novum Pharma, LLC

Reason
Subpotent Drug: Out of specification result for pramoxine hydrochloride
Recall initiated
December 7, 2016
Reported by FDA
January 25, 2017
Distribution
Nationwide

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Drug Recall Terminated Historical recordClass III

Pentasa (mesalamine) Controlled-Release Capsules, 250 mg, 240 count bottle, Rx only, Manufactured for Shire US Inc., Lexington, MA --- NDC 54092-189-81

by Shire PLC

Reason
Presence of Foreign Tablets/Capsules; 500 mg capsules were found in bottles labeled to contain 250 mg capsules
Recall initiated
December 2, 2016
Reported by FDA
January 25, 2017
Distribution
Nationwide and Puerto Rico

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Drug Recall Terminated Historical recordClass III

Risedronate Sodium Delayed-release Tablets, 35 mg, Once-a-Week, 1 tablet per blister (NDC 0093-5509-19), packaged in 4 blisters per carton (NDC 0093-5509-44), Rx only, TEVA PHARMACEUTICALS USA, INC., North Wales, PA 19454.

by Teva Pharmaceuticals USA

Reason
Failed Dissolution Specifications
Recall initiated
December 1, 2016
Reported by FDA
January 25, 2017
Distribution
Nationwide in the USA and Puerto Rico

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Drug Recall Terminated Historical recordClass II

Daytrana (methylphenidate transdermal system) Transdermal Patch, 30 mg over 9 hours (3.3 mg/hr), packaged in 30-count patches per box, Rx only, Manufactured by Noven Therapeutics, LLC, Miami, FL 33186; By Noven Pharmaceuticals, Inc., Miami, FL 33186, NDC 68968-5555-3.

by Noven Pharmaceuticals, Inc.

Reason
Defective Delivery System: Out of Specification (OOS) results for the mechanical peel force (MPF) and and/or the z-statistic values.
Recall initiated
August 22, 2016
Reported by FDA
January 18, 2017
Distribution
Nationwide within the US

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Drug Recall Terminated Historical recordClass II

Daytrana (methylphenidate transdermal system) Transdermal Patch, 20 mg over 9 hours (2.2 mg/hr), packaged in 30-count patches per box, Rx only, Manufactured by Noven Therapeutics, LLC, Miami, FL 33186; By Noven Pharmaceuticals, Inc., Miami, FL 33186, NDC 68968-5554-3.

by Noven Pharmaceuticals, Inc.

Reason
Defective Delivery System: Out of Specification (OOS) results for the mechanical peel force (MPF) and and/or the z-statistic values.
Recall initiated
August 22, 2016
Reported by FDA
January 18, 2017
Distribution
Nationwide within the US

View recall →

Drug Recall Terminated Historical recordClass II

Daytrana (methylphenidate transdermal system) Transdermal Patch, 10 mg over 9 hours (1.1mg/hr), packaged in- 30 count per box, Rx only, Manufactured by Noven Therapeutics, LLC, Miami, FL 33186; By Noven Pharmaceuticals, Inc, Miami, FL 33186, NDC 68968-5552-3

by Noven Pharmaceuticals, Inc.

Reason
Defective Delivery System: Out of Specification (OOS) results for the mechanical peel force (MPF) and and/or the z-statistic values.
Recall initiated
August 22, 2016
Reported by FDA
January 18, 2017
Distribution
Nationwide within the US

View recall →

Drug Recall Terminated Historical recordClass III

HCG-Vitamin B12 5000 IU-8 mg in 10 mL vial, Rx only, For Sub-Q & IM Injection, Pharm D Solutions, Loop West Houston, TX --- NDA 69699-1723-20

by Pharm D Solutions, LLC

Reason
Labeling; Error on Declared Strength; product description incorrectly states HCG 7500 units instead of 5000 units. The primary panel is correct
Recall initiated
October 12, 2016
Reported by FDA
January 18, 2017
Distribution
AZ and WA

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Drug Recall Terminated Historical recordClass III

Testosterone Cypionate 200 mg/mL in Sesame Oil, 4 mL and 5 mL vials, Rx only, For IM injection, Pharm D Solutions, Loop West Houston, TX --- NDA 69699-1709-04

by Pharm D Solutions, LLC

Reason
Incorrect/Undeclared Excipient; product description section of testosterone cypionate incorrectly states "in grapeseed oil" instead of "in sesame oil" . The primary panel is correct
Recall initiated
October 12, 2016
Reported by FDA
January 18, 2017
Distribution
AZ and WA

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Drug Recall Terminated Historical recordClass II

10% Premasol sulfite-free (Amino Acid) Injection, 2000 mL bulk package, Rx only, Baxter Healthcare Corporation, Clintec Nutrition Division, Deerfield, IL 60015 USA, NDC 0338-1130-06

by Baxter Healthcare Corporation

Reason
Discoloration: there were customer reports of yellow discolored solution. The yellow coloration is the result of oxidation of the amino acid tryptophan due to a damaged overpouch.
Recall initiated
December 6, 2016
Reported by FDA
January 18, 2017
Distribution
US

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Drug Recall Terminated Historical recordClass III

Cytotec (misoprostol) Tablets, 200 mcg, 100 Tablets blister pack (10X10), For in-institution use only, Rx only, Distributed by G.D. Searle, Division of Pfizer, Inc., NY, NY --- NDC 0025-1461-34

by Pfizer Inc.

Reason
Failed Impurities/Degradations Specifications; Out of specification results for two known degradation products and total impurities at 18 months
Recall initiated
September 9, 2016
Reported by FDA
January 18, 2017
Distribution
Nationwide

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Drug Recall Terminated Historical recordClass II

Testosterone Cypionate in Sesame Oil Injectable, (NY STATE), 200 mg/mL, 10 mL vial, Compounded by Wells Pharmacy, Ocala, FL

by Wells Pharmacy Network LLC

Reason
Lack of Assurance of Sterility
Recall initiated
September 21, 2016
Reported by FDA
January 11, 2017
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass II

Testosterone Cypionate in Grapeseed Oil Injectable, (NY STATE), 200 mg/mL, 10 mL vial, Compounded by Wells Pharmacy, Ocala, FL

by Wells Pharmacy Network LLC

Reason
Lack of Assurance of Sterility
Recall initiated
September 21, 2016
Reported by FDA
January 11, 2017
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass II

Vitamin D3 in Sesame Oil Injectable 50,000 IU/mL, 5 mL vial, Compounded by Wells Pharmacy, Ocala, FL

by Wells Pharmacy Network LLC

Reason
Lack of Assurance of Sterility
Recall initiated
September 21, 2016
Reported by FDA
January 11, 2017
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass II

Vitamin D3 in Sesame Oil Injectable 100,000 IU/mL, 5 mL, vial, Compounded by Wells Pharmacy, Ocala, FL

by Wells Pharmacy Network LLC

Reason
Lack of Assurance of Sterility
Recall initiated
September 21, 2016
Reported by FDA
January 11, 2017
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass II

Tri-Test 200 (CEP 100-75-25) Injectable, 200 mg/mL, 10 mL vial, Compounded by Wells Pharmacy, Ocala, FL

by Wells Pharmacy Network LLC

Reason
Lack of Assurance of Sterility
Recall initiated
September 21, 2016
Reported by FDA
January 11, 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.