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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 16,581–16,600 of 17,987 drug recalls

Drug Recall Terminated Historical recordClass III

Hydroxychloroquine Sulfate Tablets, USP, 200 mg, Rx Only, 100 Tablets per bottle, Sandoz Inc., Princeton NJ, 08540, NDC 0781-1407-01.

by Sandoz Incorporated

Reason
Failed Tablet/Capsule Specifications: Sandoz is recalling one lot of Hydroxychloroquine Sulfate Tablets, USP, 200mg, due to illegibility of the logo on some tablets.
Recall initiated
September 25, 2013
Reported by FDA
October 16, 2013
Distribution
Nationwide

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Drug Recall Terminated Historical recordClass II

Next Choice" One Dose Emergency Contraceptive (Levonorgestrel Tablet), 1.5 mg, 1 Tablet/Blister Card (NDC 52544-287-54), Manufactured by Watson Laboratories Inc, 132 Business Center Drive, Corona, CA 92880.

by Watson Laboratories Inc

Reason
Failed Tablet/Capsule Specifications: Multiple complaints for push through tablet breakage.
Recall initiated
September 23, 2013
Reported by FDA
October 16, 2013
Distribution
US. No international. NATIONWIDE

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Drug Recall Terminated Historical recordClass II

0.5% Bupivacaine HCl and Epinephrine 1:200,000 Inj., 10 mL, Single-Dose Vial, NDC 0409-9045-01, Hospira, Inc., Lake Forest, IL 60045

by Hospira Inc.

Reason
Lack of Assurance of Sterility; potential for vial breakage
Recall initiated
September 5, 2013
Reported by FDA
October 16, 2013
Distribution
Nationwide and Guam and Abu Dhabi

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Drug Recall Terminated Historical recordClass II

Oxycodone and Acetaminophen Tablets, USP 10 mg/650 mg, CII, 100 Count Bottles, Rx Only, Manufactured by: Watson Laboratories, Inc. Corona, CA 92880 USA, NDC 0591-0825-01

by Watson Laboratories Inc

Reason
Presence of Foreign Tablets/Capsules: 20 tablets of Oxycodone/APAP 7.5/500 mg were found in a sealed 100 count bottle of Oxycodone and Acetaminophen Tablets, USP 10/650 mg lot# 705791A.
Recall initiated
September 13, 2013
Reported by FDA
October 9, 2013
Distribution
Nationwide

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Drug Recall Terminated Historical recordClass II

SIH-Testosterone Cypionate 200 mg/mL Injectable, 10 mL sterile vial, The Apothecary Shoppe, 6136 E. 51st St. Tulsa, OK 74135.

by Apothecary Shoppe

Reason
Lack of Assurance of Sterility: concerns of sterility assurance with the pharmacy's independent testing laboratory
Recall initiated
September 6, 2013
Reported by FDA
October 9, 2013
Distribution
Oklahoma

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Drug Recall Terminated Historical recordClass II

Estradiol 1.25 mg, Progesterone 25 mg/mL injectable, 20 mL sterile vials, The Apothecary Shoppe, 6136 E. 51st St. Tulsa, OK 74135.

by Apothecary Shoppe

Reason
Lack of Assurance of Sterility: concerns of sterility assurance with the pharmacy's independent testing laboratory.
Recall initiated
September 6, 2013
Reported by FDA
October 9, 2013
Distribution
Oklahoma

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Drug Recall Terminated Historical recordClass II

5% Lidocaine HCl and 7.5% Dextrose Injection, USP, 2 mL Single Dose Ampuls, Rx only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-4712-01

by Hospira Inc.

Reason
Presence of Particulate Matter; report of visible particulates in the glass ampule
Recall initiated
August 29, 2013
Reported by FDA
October 9, 2013
Distribution
Nationwide

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Drug Recall Terminated Historical recordClass II

Histamine, 10 ng/mL Injectable, MDV, Rx only, Triangle Compounding Pharmacy, 3700 Regency Parkway, Suite 140, Cary NC 27518.

by Triangle Compounding

Reason
Lack of Assurance of Sterility:The product lots are being recalled due to laboratory results (from a contract lab) indicating microbial contamination. The FDA was concerned test results obtained from the recalling firm's contract testing lab may not be reliable. Hence the sterility of the products cannot be assured.
Recall initiated
September 6, 2013
Reported by FDA
October 9, 2013
Distribution
NC

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Drug Recall Terminated Historical recordClass II

Sodium Phosphate Injectable, 150mM/50mL Phosphorus 200mEq/50mL Sodium, 50 mL Single Dose Vial, Rx only, Triangle Compounding Pharmacy, 3700 Regency Parkway, Suite 140, Cary NC 27518.

by Triangle Compounding

Reason
Lack of Assurance of Sterility:The product lots are being recalled due to laboratory results (from a contract lab) indicating microbial contamination. The FDA was concerned test results obtained from the recalling firm's contract testing lab may not be reliable. Hence the sterility of the products cannot be assured.
Recall initiated
September 6, 2013
Reported by FDA
October 9, 2013
Distribution
NC

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Drug Recall Terminated Historical recordClass III

Venlafaxine (Venlafaxine Hydrochloride) extended release Tablets, 225 mg, packaged in a) 30- count bottle (NDC 0131-3268-32) and b) 90-count bottle (NDC: 0131-3268-46), Rx only, Manufactured by: Kremers Urban Pharmaceuticals Inc. For: Osmotica Pharmaceutical Corp., Wilmington, NC 28405, USA.

by Osmotica Pharmaceutical Corp

Reason
Failed Dissolution Specification:12 hour time point at 18 months of product shelf life.
Recall initiated
September 16, 2013
Reported by FDA
October 9, 2013
Distribution
Nationwide

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Drug Recall Terminated Historical recordClass II

Ifosfamide Injection 3g/60 mL, Single dose vial, Rx only, Sterile, For Intravenous Use, Refrigerate at 2-8 degrees celcius, Distributed by Pfizer Labs, Division of Pfizer Inc., New York, NY 10017, NDC 0069-4496-22

by AmeriSource Bergen

Reason
Temperature abuse: Certain vials of Ifosfamide IV products were not refrigerated at certain Amerisource Bergen Drug Corp distribution centers.
Recall initiated
September 13, 2013
Reported by FDA
October 9, 2013
Distribution
Nationwide

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Drug Recall Terminated Historical recordClass II

Ifosfamide Injection 1g/20mL, Single dose vial, Rx only, Sterile, For Intravenous Use, Refrigerate at 2-8 degrees celcius, Distributed by Pfizer Labs, Division of Pfizer Inc., New York, NY 10017, NDC 0069-4495-22

by AmeriSource Bergen

Reason
Temperature abuse: Certain vials of Ifosfamide IV products were not refrigerated at certain Amerisource Bergen Drug Corp distribution centers.
Recall initiated
September 13, 2013
Reported by FDA
October 9, 2013
Distribution
Nationwide

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Drug Recall Terminated Historical recordClass II

Acetaminophen Tablets, 500 mg, 100-count bottles, Distributed by: Marlex Pharmaceuticals, Inc., New Castle, DE 19720, List No. 152, NDC 10135-152-01, UPC 3 10135 15201 8.

by Marlex Pharmaceuticals, Inc.

Reason
CGMP Deviations: The recalled acetaminophen tablet lot was not manufactured under current good manufacturing practices as noted by a recent inspection of the manufacturing firm.
Recall initiated
August 8, 2013
Reported by FDA
October 9, 2013
Distribution
Nationwide.

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Drug Recall Terminated Historical recordClass II

Walgreens Progesterone in Ethyl Oleate 50 mg per mL Injection, 10 mL vial, Inject 1 mL Intramuscularly as directed by physician, Walgreens Specialty Pharmacy, Fresco, TX.

by Walgreens Co

Reason
Lack of Assurance of Sterility: Walgreens Specialty Pharmacy is recalling one lot of Progesterone in Ethyl Oleate sterile injection due to concerns of sterility assurance with the specialty pharmacy's independent testing laboratory.
Recall initiated
August 23, 2013
Reported by FDA
October 2, 2013
Distribution
Nationwide

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Drug Recall Terminated Historical recordClass II

Pyridostigmine Bromide Tablets 60 mg, USP Rx Only 100 Tablets, Manufactured and Distributed by: CorePharma, LLC Middlesex, NJ 08846 NDC 64720-128-10 NDC 64720-128-10

by Core Pharma Llc

Reason
Failed Stability Specifications: Pyridostigmine Bromide tablets, is being recalled due to an out of specification test result during stablity testing.
Recall initiated
July 2, 2013
Reported by FDA
October 2, 2013
Distribution
Nationwide

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Drug Recall Terminated Historical recordClass III

Hydrocodone Bitartrate and Acetaminophen Tablets, 7.5 mg/650 mg Tablets, 500 Count Bottle, Manufactured by: Watson Laboratories, Inc, Cocona, CA 92880, NDC 0591-2611-05.

by Watson Laboratories Inc

Reason
Defective Container: Defective bottles may not have tamper evident seals properly seated, and therefore it may be difficult to determine if the product had been opened or tampered with.
Recall initiated
August 30, 2013
Reported by FDA
September 25, 2013
Distribution
Nationwide

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Drug Recall Terminated Historical recordClass II

Hydroxocobalamin MDV 5 mg/mL (5,000 mcg/mL) Inj., 10 mL vial X 3, Eastern States Compounding Pharmacy, Littleton, NH 03561

by Northern New England Compounding Pharmacy LLC

Reason
Lack of Assurance of Sterility: The pharmacy is recalling one lot of Hydroxocobalamin MDV 5mg/mL due to failed sterility results by a third party contract testing lab. Hence the sterility of the product cannot be assured.
Recall initiated
September 5, 2013
Reported by FDA
September 25, 2013
Distribution
CT

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Drug Recall Terminated Historical recordClass II

Vancomycin PF (BSS) 1%, 1 mL, Avella Specialty Pharmacy, Phoenix, AZ 85085, 877-782-7684

by Avella of Deer Valley, Inc.

Reason
Lack of Assurance of Sterility: Avella Specialty Pharmacy is recalling bevacizumab and vancomycin due to concerns of sterility assurance with the specialty pharmacy's independent testing laboratory.
Recall initiated
September 9, 2013
Reported by FDA
September 25, 2013
Distribution
Nationwide and Puerto Rico

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Drug Recall Terminated Historical recordClass II

Bevacizumab 1.25 mg/0.05 mL PF, Avella Specialty Pharmacy, Phoenix, AZ, 85085, 877-782-7684

by Avella of Deer Valley, Inc.

Reason
Lack of Assurance of Sterility: Avella Specialty Pharmacy is recalling bevacizumab and vancomycin due to concerns of sterility assurance with the specialty pharmacy's independent testing laboratory.
Recall initiated
September 9, 2013
Reported by FDA
September 25, 2013
Distribution
Nationwide and Puerto Rico

View recall →

Drug Recall Terminated Historical recordClass III

SPIRIVA HandiHaler (Tiotropium Bromide Inhalation Powder) Capsules 18 mcg per dose, Rx only, a) 10 count blister (NDC 0597-0075-27), b) 30 count blister (NDC 0597-0075-41), c) 90 count blister (NDC 0597-0075-47), d) 5 count blister physician sample (NDC 0597-0075-75), Manufactured by: Boehringer Ingelheim (BI) Pharma, GmbH & Co. KG, Ingelheim, Germany

by Boehringer Ingelheim Roxane Inc

Reason
Presence of Foreign Substance: This recall is being conducted due to the potential for extrinsic foreign particles in the API used to manufacture SPIRIVA Handihaler
Recall initiated
August 30, 2013
Reported by FDA
September 25, 2013
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.