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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 9,921–9,940 of 17,974 drug recalls

Drug Recall Terminated Historical recordClass II

Ephedrine Sulfate in 0.9% Sodium Chloride in all strengths, all doses, and all packaging.

by PharMEDium Services, LLC

Reason
Lack of sterility assurance.
Recall initiated
December 27, 2017
Reported by FDA
February 28, 2018
Distribution
U.S.A. Nationwide

View recall →

Drug Recall Terminated Historical recordClass II

Fentanyl Citrate and Bupivacaine HCl in 0.9% Sodium Chloride in all strengths, all doses, and all packaging.

by PharMEDium Services, LLC

Reason
Lack of sterility assurance.
Recall initiated
December 27, 2017
Reported by FDA
February 28, 2018
Distribution
U.S.A. Nationwide

View recall →

Drug Recall Terminated Historical recordClass II

Fentanyl Citrate and Ropivacaine HCl in 0.9% Sodium Chloride in all strengths, all doses, and all packaging.

by PharMEDium Services, LLC

Reason
Lack of sterility assurance.
Recall initiated
December 27, 2017
Reported by FDA
February 28, 2018
Distribution
U.S.A. Nationwide

View recall →

Drug Recall Terminated Historical recordClass II

Bupivacaine HCl in 0.9% Sodium Chloride in all doses, all strengths, and packaging.

by PharMEDium Services, LLC

Reason
Lack of sterility assurance.
Recall initiated
December 27, 2017
Reported by FDA
February 28, 2018
Distribution
U.S.A. Nationwide

View recall →

Drug Recall Terminated Historical recordClass II

HYDROmorphone HCl in Sodium Chloride 0.9% in all doses, all strengths, and all packaging.

by PharMEDium Services, LLC

Reason
Lack of sterility assurance.
Recall initiated
December 27, 2017
Reported by FDA
February 28, 2018
Distribution
U.S.A. Nationwide

View recall →

Drug Recall Terminated Historical recordClass III

Metformin Hydrochloride Tablets, USP 1000 mg, 500-count bottles, Rx Only, Manufactured for: Aurobindo Pharma USA, Inc. 2400 Route 130 North Dayton, NJ 08810, Manufactured by: Aurobindo Pharma Limited Unit -VII (SEZ)) Mahabubnagar (Dt)_509302 India, NDC 65862-010-05.

by Aurobindo Pharma Ltd.

Reason
Presence of Foreign Tablet: Metformin BP 1000mg was found in bottle of Metformin HCl 1000mg
Recall initiated
February 2, 2018
Reported by FDA
February 28, 2018
Distribution
Nationwide within the US

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Drug Recall Terminated Historical recordClass I

HCG 5,000 IU/mL + Methylcobalamin 500 mcg/mL Injection 5 mL, Multi-Dose Vial, Sterile, Rx Only, Compounded by The Compounding Pharmacy of America, 6216 Highland Place Way, Ste. 101A Knoxville, TN 37919 Ph (855) 277-2488 Fax (888) 689-9892

by The Compounding Pharmacy of America

Reason
Non-Sterility
Recall initiated
January 12, 2018
Reported by FDA
February 21, 2018
Distribution
TN, SC

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Drug Recall Terminated Historical recordClass II

Aripiprazole Tablets, USP, 10 mg, 100 Tablets (10 x 10) unit dose blisters [NDC60687-179-11; UPC (01) 003 60687 179 11 7] per carton (NDC 60687-179-01), Rx Only, Distributed by: American Health Packaging, Columbus, Ohio 43217.

by American Health Packaging

Reason
CGMP Deviations: lot made with active pharmaceutical ingredient that did not meet all its intended specifications.
Recall initiated
January 19, 2018
Reported by FDA
February 21, 2018
Distribution
Nationwide in the USA

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Drug Recall Terminated Historical recordClass III

Fluoxetine Tablets USP, 10 mg, 30-count bottle, Rx only, Manufactured in Israel by: Teva Pharmaceuticals IND, LTD, Jerusalem, 9777402, Israel, Manufactured for: Teva Pharmaceuticals USA, INC., North Wales, PA 19454, NDC 0093-7188-56

by Teva Pharmaceuticals USA

Reason
Failed impurities/ degradation specifications: Teva Pharmaceuticals USA, Inc. is voluntarily recalling all lots within expiry due to out of specification (OOS) test result for the lactoside impurity obtained during routine stability testing activities.
Recall initiated
February 5, 2018
Reported by FDA
February 21, 2018
Distribution
Distributed throughout the United States

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Drug Recall Terminated Historical recordClass II

100 mcg / mL Phenylephrine HCl (Preservative Free) Injection, 10 mL syringe, Rx only, PharMEDium Serivces, LLC

by PharMEDium Services, LLC

Reason
Lack of assurance of sterility: Three lots were released where there was a failure to follow proper testing and investigation procedures. Product may be out of specification (OOS) for endotoxin.
Recall initiated
February 5, 2018
Reported by FDA
February 21, 2018
Distribution
Product was distributed to SC, FL, NY, NY,WA

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Drug Recall Terminated Historical recordClass II

15 units Oxytocin added to 0.9% Sodium Chloride Injection, 250 mL Viaflex Bag, Rx only, PharMEDium Serivces, LLC

by PharMEDium Services, LLC

Reason
Lack of assurance of sterility: Three lots were released where there was a failure to follow proper testing and investigation procedures. Product may be out of specification (OOS) for endotoxin.
Recall initiated
February 5, 2018
Reported by FDA
February 21, 2018
Distribution
Product was distributed to SC, FL, NY, NY,WA

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Drug Recall Terminated Historical recordClass III

BonaDur For Men (lidocaine) spray, 10 mg per spray, Net Contents .25 fl. oz. (7.4 mL) spray bottles, Manufactured by WebRx Pharmacy Palace, Sarasota, FL 34232; NDC 70582-999-74

by Webrx dba RxPalace.com

Reason
CGMP Deviations: not manufactured according to current good manufacturing practices.
Recall initiated
February 7, 2018
Reported by FDA
February 21, 2018
Distribution
NY

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Drug Recall Terminated Historical recordClass II

Famciclovir Tablets, 500 mg, 30-count bottles, Rx Only, Manufactured For: Camber Pharmaceuticals. Inc. Piscataway, NJ 08854 By: HETERO, Hetero Labs Limited, Unit V, Polepally, Jadcherla, Mahaboob Nagar-509 301, India. NDC 31722-708-30

by Hetero Labs Limited Unit V

Reason
Temperature Abuse: Complaints of tablets being wet and stuck together with tablet coating peeled and disintegrated as a result of prolonged exposure to high temp during distribution.
Recall initiated
December 22, 2017
Reported by FDA
February 21, 2018
Distribution
Nationwide in the USA.

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Drug Recall Terminated Historical recordClass III

NORCO (Hydrocodone Bitartrate and Acetaminophen) Tablets, USP, 10 mg/325 mg, 100-count bottles, Rx Only, Distributed by: Allergan USA, Inc., Irvine, CA 92612, NDC 0023-6022-01.

by ALLERGAN

Reason
Labeling: Not Elsewhere Classified: does not have the required "CII" controlled drug classification indication on the primary label.
Recall initiated
February 2, 2018
Reported by FDA
February 21, 2018
Distribution
Nationwide in the USA

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Drug Recall Terminated Historical recordClass II

Nose to Toes Skin Antisepsis, Oral Cleansing and Nasal Antisepsis System. Contains: Three 2-packs of 2% Chlorhexidine Gluconate Cloth Patient Preoperative Skin Preparation and One 7ml Burst Pouch of Corinz Antiseptic Cleansing and Moisturizing Oral Rinse, I Ultra-Soft Toothbrush, 1 Applicator Swab treated with Sodium Bicarbonate. 1 Bottle of 3M Skin and Nasal Antiseptic (Povidone-Iodine Solution 5%w/w (0.5%available iodine) USP) Patient Preoperative Skin Preparation 0.14 fl oz (4ml), 4 sterile swabs. Sage Products, Inc., 3909 Three Oaks Road, Cary, IL 60013. Product Code 9010 UPC 6 18029 79139 9

by Sage Products Inc

Reason
Cross Contamination With Other Products: Oral care solutions were manufactured by a third party supplier on equipment shared with non-pharmaceutical products
Recall initiated
August 22, 2017
Reported by FDA
February 21, 2018
Distribution
Distributed Nationwide in the USA and Puerto Rico, Canada, United Kingdom, Ireland, Netherlands, New Zealand

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Drug Recall Terminated Historical recordClass II

Skin antisepsis and oral cleansing. Contains Three 2-packs of 2% Chlorhexidine Gluconate Cloth Patient Preoperative Skin Preparation and One 7ml Burst Pouch of Corinz Antiseptic Cleansing and Moisturizing Oral Rinse, I Ultra-Soft Toothbrush, 1 Applicator Swab treated with Sodium Bicarbonate. Sage Products, Inc., 3909 Three Oaks Road, Cary, IL 60013. Product Code 9009 UPC 6 18029 79140 5

by Sage Products Inc

Reason
Cross Contamination With Other Products: Oral care solutions were manufactured by a third party supplier on equipment shared with non-pharmaceutical products
Recall initiated
August 22, 2017
Reported by FDA
February 21, 2018
Distribution
Distributed Nationwide in the USA and Puerto Rico, Canada, United Kingdom, Ireland, Netherlands, New Zealand

View recall →

Drug Recall Terminated Historical recordClass II

Q Care RX Petite Oral Cleansing & Suctioning System with 0.12% Chlorhexidine Gluconate (CHG) Oral Rinse. Contains 1 Covered Yankauer and Y-Connector, 2 Untreated Petite Suction Toothbrush packages, 2 Single dose bottles of 0.12% CHG Oral Rinse, 4 Petite Suction Oral Swab packages with Corinz Antiseptic Cleansing and Moisturizing Oral Rinse, 2 Oropharyngeal Suction Catheter packages. Sage Products, Inc., 3909 Three Oaks Road, Cary, IL 60013. Product Code 6974-S UPC 6 18029 83097 5

by Sage Products Inc

Reason
Cross Contamination With Other Products: Oral care solutions were manufactured by a third party supplier on equipment shared with non-pharmaceutical products
Recall initiated
August 22, 2017
Reported by FDA
February 21, 2018
Distribution
Distributed Nationwide in the USA and Puerto Rico, Canada, United Kingdom, Ireland, Netherlands, New Zealand

View recall →

Drug Recall Terminated Historical recordClass II

Q Care RX Petite Oral Cleansing & Suctioning System with 0.12% Chlorhexidine Gluconate (CHG) Oral Rinse. Contains 1 Covered Yankauer and Y-Connector, 2 Untreated Petite Suction Toothbrush packages, 2 Single dose bottles of 0.12% CHG Oral Rinse, 4 Petite Suction Oral Swab packages with Corinz Antiseptic Cleansing and Moisturizing Oral Rinse, 2 Oropharyngeal Suction Catheter packages. Sage Products, Inc., 3909 Three Oaks Road, Cary, IL 60013. Product Code 6974 UPC 6 18029 83097 5

by Sage Products Inc

Reason
Cross Contamination With Other Products: Oral care solutions were manufactured by a third party supplier on equipment shared with non-pharmaceutical products
Recall initiated
August 22, 2017
Reported by FDA
February 21, 2018
Distribution
Distributed Nationwide in the USA and Puerto Rico, Canada, United Kingdom, Ireland, Netherlands, New Zealand

View recall →

Drug Recall Terminated Historical recordClass II

Q.Care Oral Cleansing & Suctioning System Suction Toothbrush Compatible with Chlorhexidine Gluconate (CHG) Oral Rinse q4. Contains 1 Covered Yankauer and Y-Connector, 1 Untreated Suction Toothbrush packages, 2 Single dose bottles of 0.12% CHG Oral Rinse, 4 Suction Oral Swab packages with Corinz Antiseptic Cleansing and Moisturizing Oral Rinse, 2 Oropharyngeal Suction Catheter packages. Sage Products, Inc., 3909 Three Oaks Road, Cary, IL 60013. Product Code 6964 UPC 6 18029 83075 3

by Sage Products Inc

Reason
Cross Contamination With Other Products: Oral care solutions were manufactured by a third party supplier on equipment shared with non-pharmaceutical products
Recall initiated
August 22, 2017
Reported by FDA
February 21, 2018
Distribution
Distributed Nationwide in the USA and Puerto Rico, Canada, United Kingdom, Ireland, Netherlands, New Zealand

View recall →

Drug Recall Terminated Historical recordClass II

Q.Care Oral Cleansing & Suctioning System Suction Toothbrush Compatible with Chlorhexidine Gluconate (CHG) Oral Rinse q4. Contains 1 Covered Yankauer and Y-Connector, 2 Untreated Suction Toothbrush packages, 4 Suction Oral Swab packages with Perox-A-Mint solution, 2 Oropharyngeal Suction Catheter packages. Sage Products, Inc., 3909 Three Oaks Road, Cary, IL 60013. Product Code 6924 UPC 6 18029 83033 3

by Sage Products Inc

Reason
Cross Contamination With Other Products: Oral care solutions were manufactured by a third party supplier on equipment shared with non-pharmaceutical products
Recall initiated
August 22, 2017
Reported by FDA
February 21, 2018
Distribution
Distributed Nationwide in the USA and Puerto Rico, Canada, United Kingdom, Ireland, Netherlands, New Zealand

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.