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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 10,921–10,940 of 17,974 drug recalls

Drug Recall Terminated Historical recordClass I

Vancomycin Hydrochloride for Injection, USP, 10 grams, Pharmacy Bulk Package - Not For Direct Infusion, For Intravenous Use, packaged in 100 mL glass vial, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-6510-01

by Hospira Inc., A Pfizer Company

Reason
Presence of Particulate Matter: A hair was found stuck to the stopper of inside a single vial. The hair came in contact with the reconstituted drug product.
Recall initiated
January 24, 2017
Reported by FDA
April 12, 2017
Distribution
U.S. Nationwide

View recall →

Drug Recall Terminated Historical recordClass I

Ibuprofen Lysine Injection, 20 mg/2 mL (10 mg/mL), 2 mL Single-Dose Vial (NDC 39822-1030-1), packaged in 3 x 2 mL Single-Dose Vials per carton (NDC 39822-1030-2); Rx only, Distributed by: X-Gen Pharmaceuticals, Inc., Big Flats, NY 14814; Manufactured by: Exela Pharma Sciences, LLC, Lenoir, NC 28645.

by X-Gen Pharmaceuticals Inc.

Reason
Presence of Particulate Matter
Recall initiated
February 8, 2017
Reported by FDA
April 12, 2017
Distribution
Nationwide in the USA.

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Drug Recall Terminated Historical recordClass III

Ciclopirox Olamine Cream USP, 0.77%, packaged in a) 15 g tubes (NDC 0713-0638-15), b) 30 g tubes (NDC 0713-0638-31), and c) 90 g tubes (NDC 0713-0638-18), Rx only, Manufactured by: G&W Laboratories, Inc., South Plainfeld, NJ 07080.

by G & W Laboratories, Inc.

Reason
Labeling: Incorrect or Missing Package Insert: product lots packaged with an out-of-date insert.
Recall initiated
March 20, 2017
Reported by FDA
April 12, 2017
Distribution
Nationwide in the USA and Puerto Rico

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Drug Recall Terminated Historical recordClass III

Adalat CC (nifedipine) Extended-Release Tablets, 90 mg, 100-count bottles, Rx Only, Manufactured for Almatica Pharma Inc. Pine Brook, NJ 07058 USA, NDC 5242749601

by Alvogen, Inc

Reason
Cross Contamination with another product:residual powder found in inlet air duct identified as sorafenib
Recall initiated
March 7, 2017
Reported by FDA
April 12, 2017
Distribution
Nationwide

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Drug Recall Terminated Historical recordClass III

Adalat CC (nifedipine) Extended-Release Tablets, 60 mg, 100-count bottles, Rx Only, Manufactured for Almatica Pharma Inc. Pine Brook, NJ 07058 USA, NDC 5242749501

by Alvogen, Inc

Reason
Cross Contamination with another product:residual powder found in inlet air duct identified as sorafenib
Recall initiated
March 7, 2017
Reported by FDA
April 12, 2017
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass III

Adalat CC (nifedipine) Extended-Release Tablets, 30 mg, 100-count bottles, Rx Only, Manufactured for Almatica Pharma Inc. Pine Brook, NJ 07058 USA, NDC 5242749401

by Alvogen, Inc

Reason
Cross Contamination with another product:residual powder found in inlet air duct identified as sorafenib
Recall initiated
March 7, 2017
Reported by FDA
April 12, 2017
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass III

Adalat CC (nifedipine) Extended-Release Tablets, 90 mg, 100-count bottles, Rx Only, Manufactured for Almatica Pharma Inc. Pine Brook, NJ 07058 USA, NDC 50419-70305

by Alvogen, Inc

Reason
Cross Contamination with another product:residual powder found in inlet air duct identified as sorafenib
Recall initiated
March 7, 2017
Reported by FDA
April 12, 2017
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass III

Nifedipine Extended-Release Tablets, 90 mg, 100-count bottles, Rx Only, Manufactured for Alvogen Inc. Pine Brook, NJ 07058 USA, NDC 47781-370-01.

by Alvogen, Inc

Reason
Cross Contamination with another product:residual powder found in inlet air duct identified as sorafenib
Recall initiated
March 7, 2017
Reported by FDA
April 12, 2017
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass III

Nifedipine Extended-Release Tablets, 60 mg, 100-count bottles, Rx Only, Manufactured for Alvogen Inc. Pine Brook, NJ 07058 USA, NDC 47781-369-01.

by Alvogen, Inc

Reason
Cross Contamination with another product:residual powder found in inlet air duct identified as sorafenib
Recall initiated
March 7, 2017
Reported by FDA
April 12, 2017
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass III

Adalat CC (nifedipine) Extended Release Tablets, 60 mg, 100- count bottles, Rx only Manufactured for Almatica, Almatica Pharma Inc. Pinebrook, NJ 07058 USA, NDC 50419-702-05

by Alvogen, Inc

Reason
Cross Contamination with another product:residual powder found in inlet air duct identified as sorafenib
Recall initiated
March 7, 2017
Reported by FDA
April 12, 2017
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass III

Adalat CC (nifedipine) Extended Release Tablets 30 mg, 100-count bottles, Rx only, Manufactured for Bayer Healthcare Bayer Healthcare Pharmaceuticals Inc. Whippany, NJ 07901 Manufactured in Germany, NDC 50419-701-05

by Alvogen, Inc

Reason
Cross Contamination with another product:residual powder found in inlet air duct identified as sorafenib
Recall initiated
March 7, 2017
Reported by FDA
April 12, 2017
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass III

Nifedipine Extended-Release Tablets, 30 mg, 100-count bottles, Rx Only, Manufactured for Alvogen Inc. Pine Brook, NJ 07058 USA, NDC 47781-368-01.

by Alvogen, Inc

Reason
Cross Contamination with another product:residual powder found in inlet air duct identified as sorafenib
Recall initiated
March 7, 2017
Reported by FDA
April 12, 2017
Distribution
Nationwide

View recall →

Drug Recall Ongoing Historical recordClass II

Ventolin HFA (albuterol sulfate) Inhalation Aerosol, 90 mcg per actuation, 200 Metered Inhalations, Net Wt. 18 g inhalers, Rx only, GlaxoSmithKline, Research Triangle Park, NC 22709, NDC 0173-0682-20.

by GlaxoSmithKline, LLC

Reason
Defective Delivery System: Elevated number of units with out of specification results for leak rate.
Recall initiated
March 22, 2017
Reported by FDA
April 12, 2017
Distribution
Nationwide in the USA and Puerto Rico

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Drug Recall Terminated Historical recordClass II

Kalbitor (ecallantide), 10mg/mL, packaged in 3 vials per Carton, Rx Only, Dynax Corp., Burlington, MA. NDC47783-101-01

by Shire

Reason
Presence of Particulate Matter: Glass
Recall initiated
March 17, 2017
Reported by FDA
April 12, 2017
Distribution
Nationwide and Kuwait

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Drug Recall Terminated Historical recordClass III

Montelukast sodium tablets, 10 mg, 30-count bottle, Rx Only, Manufactured for: Camber Pharmaceuticals, Inc., Piscataway, NJ 08854, By: HETERO Labs Limited, Unit V, Polepally, Jadcherla, Mahaboob Nagar - 509 301, India, NDC 31722-726-30

by Hetero USA Inc

Reason
Discoloration: the firm received a complaint of a sealed bottle in which tablets inside had blue spots and a blue powder inside the bottle.
Recall initiated
January 7, 2017
Reported by FDA
April 5, 2017
Distribution
US Nationwide

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Drug Recall Terminated Historical recordClass II

Metronidazole Injection, USP, 500 mg/100 mL, Rx only, Manufactured for: Claris Lifesciences Inc. North Brunswick NJ, 08902, By: Claris Injectable Ltd. Gujarat, India, NDC 36000-001-24

by Claris Lifesciences Inc

Reason
Lack of Assurance of Sterility: there is potential of a leak from the primary container which may result in a potential breach of sterility and contamination of the product.
Recall initiated
March 10, 2017
Reported by FDA
April 5, 2017
Distribution
Nationwide

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Drug Recall Terminated Historical recordClass II

Ciprofloxacin in Dextrose (5%) Injection, USP, 400 mg in 200 mL 5% Dextrose, Rx only, Manufactured for: Claris Lifesciences Inc. North Brunswick NJ, 08902, By: Claris Injectable Ltd. Gujarat, India, NDC 36000-009-24

by Claris Lifesciences Inc

Reason
Lack of Assurance of Sterility: there is potential of a leak from the primary container which may result in a potential breach of sterility and contamination of the product.
Recall initiated
March 10, 2017
Reported by FDA
April 5, 2017
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass II

Sensodyne Repair & Protect Whitening, (stannous fluoride 0.45% (0.15% w/v fluoride ion)), Net Wt. 3.4 oz, Distributed by Glaxo SmithKline Consumer Healthcare LP Moon Township PA 15108 --- NDC 0135-0575-01, UPC UPC: 3 10158 84060 2

by GSK Consumer Healthcare

Reason
Presence of Foreign Substance; low concentration of an additional flavoring ingredient, Patchouli oil resulting in complaints of off flavor/scent
Recall initiated
March 6, 2017
Reported by FDA
April 5, 2017
Distribution
Nationwide

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Drug Recall Terminated Historical recordClass II

Atorvastatin Calcium Tablets, 10 mg*, 100-count Unit Dose Tablets (10 x 10) per carton, Rx only, Manufactured by: Mylan Pharmaceuticals Inc., Morgantown, WV 26505 U.S.A.., NDC 51079-208-20

by Mylan Institutional, Inc. (d.b.a. UDL Laboratories)

Reason
Microbial Contamination of Non-Sterile Products: potential of an elevated bioburden with identification of objectionable organisms.
Recall initiated
March 21, 2017
Reported by FDA
April 5, 2017
Distribution
Nationwide in the USA

View recall →

Drug Recall Terminated Historical recordClass II

Atorvastatin Calcium Tablets, 80 mg*, packaged in a) 90-count bottles (NDC 0378-3953-09) and b) 500-count bottles (NDC 0378-3953-07), Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV 26505 U.S.A.

by Mylan Pharmaceuticals Inc.

Reason
Microbial Contamination of Non-Sterile Products: potential of an elevated bioburden with identification of objectionable organisms.
Recall initiated
March 20, 2017
Reported by FDA
April 5, 2017
Distribution
Nationwide in the USA and Puerto Rico

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.