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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 17,661–17,680 of 17,987 drug recalls

Drug Recall Terminated Historical recordClass II

Synthroid (levothyroxine sodium) Tablets USP, 75 mcg, Rx Only, 90-Count Bottle, Abbott Laboratories, North Chicago, IL 60064, NDC: 0074-5182-90.

by Abbott Laboratories

Reason
Defective Container: A number of Synthroid bottles have a localized thin wall defect on the bottom which may potentially impact the stability of the tablets.
Recall initiated
July 19, 2012
Reported by FDA
October 3, 2012
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass II

Synthroid (levothyroxine sodium) Tablets USP, 50 mcg, Rx Only, 90-Count Bottle, Abbott Laboratories, North Chicago, IL 60064, NDC: 0074-4552-90.

by Abbott Laboratories

Reason
Defective Container: A number of Synthroid bottles have a localized thin wall defect on the bottom which may potentially impact the stability of the tablets.
Recall initiated
July 19, 2012
Reported by FDA
October 3, 2012
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass II

Fentanyl Transdermal System, 100 mcg/h, each transdermal system contains: 10 mg fentanyl and 0.4 mL alcohol USP, Rx only, supplied in single pouches (NDC 0591-3214-54 (pouch)), 5 pouches per carton (NDC 0591-3214-72 (Carton)), Manufactured by Watson laboratories Inc., Corona, CA, Distributed by: Watson, Pharma Inc.

by Actavis

Reason
Subpotent; some patches may not contain fentanyl gel
Recall initiated
July 11, 2012
Reported by FDA
October 3, 2012
Distribution
Nationwide

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Drug Recall Terminated Historical recordClass III

Thallous Chloride Tl 201 Injection, Diagnostic Sterile, Non-Pyrogenic Solution, a) 2.8 mL (NDC 0019N12028) b) 6.3ml (NDC 0019N12063) For Intravenous Administration, each milliliter contains 37 MBq (1 mCi) Thallous Chloride Tl 201 (no carrier added) at date and time of calibration, 9 mg sodium chloride and 0.9% (v/v) benzyl alcohol as a preservative, RX, Mallinckrodt Inc., St. Louis, MO 63134

by Mallinckrodt Inc

Reason
Labeling: Correct Labeled Product Miscart/Mispack: labels on outer containers do not match labels on vials (the correct label)
Recall initiated
July 30, 2012
Reported by FDA
October 3, 2012
Distribution
AZ, CT, MO, MS, PA, FL, WA, NC, CA, TX, OK

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Drug Recall Terminated Historical recordClass II

Atrovent HFA Inhalation Aerosol, (ipratropium bromide) 12.9 grams, 200 metered actuations, Rx only, Packaged Exclusively by: Dispensing Solutions, Inc., Santa Ana, CA --- NDC 68258-8952-01, DSI product #8A0947

by Dispensing Solutions, Inc

Reason
Label Mix up; side panel of sticker label applied by Dispensing Solutions Inc. incorrectly indicates product name as Ventolin HFA 90 mcg instead of correctly as Atrovent HFA 12.9 grams Inhalation Aerosol
Recall initiated
August 28, 2012
Reported by FDA
October 3, 2012
Distribution
US: IN & WI

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Drug Recall Terminated Historical recordClass II

Lactated Ringer's Injection USP, packaged in a) 250 mL AVIVA Container, product code 6E2322B, NDC 0338-6307-02; b) 500 mL AVIVA Container, product code 6E2323, NDC 0338-6307-03; Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015 USA

by Baxter Healthcare Corp.

Reason
Chemical Contamination: The IV solutions were packaged in AVIVA containers which may contain trace levels of cumene hydroperoxide (CHP).
Recall initiated
September 21, 2012
Reported by FDA
October 3, 2012
Distribution
Nationwide and Puerto Rico

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Drug Recall Terminated Historical recordClass II

0.9% Sodium Chloride Injection USP, packaged in a) 250 mL AVIVA Container, product code 6E1322, NDC 0338-6304-02; b) 500 mL AVIVA Container, product code 6E1323, NDC 0338-6304-03; Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015 USA

by Baxter Healthcare Corp.

Reason
Chemical Contamination: The IV solutions were packaged in AVIVA containers which may contain trace levels of cumene hydroperoxide (CHP).
Recall initiated
September 21, 2012
Reported by FDA
October 3, 2012
Distribution
Nationwide and Puerto Rico

View recall →

Drug Recall Terminated Historical recordClass II

5% Dextrose and 0.45% Sodium Chloride Injection USP, packaged in a 500 mL AVIVA Container, Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015 USA; product code 6E0173, NDC 0338-6308-03

by Baxter Healthcare Corp.

Reason
Chemical Contamination: The IV solutions were packaged in AVIVA containers which may contain trace levels of cumene hydroperoxide (CHP).
Recall initiated
September 21, 2012
Reported by FDA
October 3, 2012
Distribution
Nationwide and Puerto Rico

View recall →

Drug Recall Terminated Historical recordClass II

10% Dextrose Injection USP, packaged in a 500 mL AVIVA Container, Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015 USA; product code 6E0163, NDC 0338-6347-03

by Baxter Healthcare Corp.

Reason
Chemical Contamination: The IV solutions were packaged in AVIVA containers which may contain trace levels of cumene hydroperoxide (CHP).
Recall initiated
September 21, 2012
Reported by FDA
October 3, 2012
Distribution
Nationwide and Puerto Rico

View recall →

Drug Recall Terminated Historical recordClass II

5% Dextrose Injection USP, packaged in a) 250 mL AVIVA Container, product code 6E0062, NDC 0338-6346-02; b) 500 mL AVIVA Container, product code 6E0063, NDC 0338-6346-03; Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015 USA

by Baxter Healthcare Corp.

Reason
Chemical Contamination: The IV solutions were packaged in AVIVA containers which may contain trace levels of cumene hydroperoxide (CHP).
Recall initiated
September 21, 2012
Reported by FDA
October 3, 2012
Distribution
Nationwide and Puerto Rico

View recall →

Drug Recall Terminated Historical recordClass II

Propofol Injectable Emulsion, 1%, packaged in a) 20 mL Single patient infusion vial, 200 mg/20 mL (10 mg/mL), NDC 0409-4699-30; b) 50 mL Single patient infusion vial, 500 mg/50 mL (10 mg/mL), NDC 0409-4699-33; c) 100 mL Single patient infusion vial, 1 g/100 mL (10 mg/mL), NDC 0409-4699-24; Rx only, Hospira, Inc., Lake Forest, IL 60045 USA

by Hospira Inc.

Reason
Presence of Particulate Matter: A single visible particulate was observed and confirmed in sample bottles of the recalled lots during retain inspection.
Recall initiated
August 29, 2012
Reported by FDA
October 3, 2012
Distribution
Nationwide

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Drug Recall Terminated Historical recordClass II

CARDIOGEN-82 (Rubidium Rb 82 Generator), 140 millicurie, Rx Only, For Elution of sterile nonpyrogenic Rubidium Chloride Rb 82, Manufactured for: Bracco Diagnostics Inc. Princeton, NJ 08543 by Medi-Physics, Inc. South Plainfield, NJ 07080, NDC 0270-0091-01

by Bracco Diagnostics Inc

Reason
GMP deviation; Sr-82 levels exceeded alert limit specification
Recall initiated
June 1, 2012
Reported by FDA
October 3, 2012
Distribution
Nationwide and United Kingdom

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Drug Recall Terminated Historical recordClass III

Enalapril Maleate Tablet, USP 5mg 30 Tablet bottle, Rx, Apace Packaging LLC, Ft. Run, KY 42133, NDC 15338-211-30

by Apace KY LLC

Reason
Labeling Illegible: Some bottles labels have incomplete NDC numbers and missing strength.
Recall initiated
September 4, 2012
Reported by FDA
September 26, 2012
Distribution
Nationwide

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Drug Recall Terminated Historical recordClass II

Paclitaxel Injection, 6 mg/mL, 50 mL Single Dose Vial, Rx only, antineoplastic/cytotoxic agent; Manufactured for Hospira, Inc., Lake Forest, IL 60045, Product of Australia; N DC 61703-342-50

by Hospira Inc.

Reason
The affected lots of Carboplatin Injection, Cytarabine Injection, Methotrexate Injection, USP, and Paclitaxel Injection are being recalled due to visible particles embedded in the glass located at the neck of the vial. There may be the potential for product to come into contact with the embedded particles and the particles may become dislodged into the solution.
Recall initiated
June 27, 2012
Reported by FDA
September 26, 2012
Distribution
Nationwide, including Puerto Rico and Guam. Product was also distributed internationally to Australia, Belgium, Canada, France, Germany, Korea, Malaysia, New Zealand, Norway, Pakistan, Philippines, Portugal, Singapore, Sweden, Thailand and Vietnam

View recall →

Drug Recall Terminated Historical recordClass II

Methotrexate Injection, USP, 25 mg/mL, 40 mL Single Dose Vial, Rx only, antineoplastic/cytotoxic agent; Manufactured for Hospira, Inc., Lake Forest, IL 60045, Product of Australia; NDC 61703-408-41

by Hospira Inc.

Reason
The affected lots of Carboplatin Injection, Cytarabine Injection, Methotrexate Injection, USP, and Paclitaxel Injection are being recalled due to visible particles embedded in the glass located at the neck of the vial. There may be the potential for product to come into contact with the embedded particles and the particles may become dislodged into the solution.
Recall initiated
June 27, 2012
Reported by FDA
September 26, 2012
Distribution
Nationwide, including Puerto Rico and Guam. Product was also distributed internationally to Australia, Belgium, Canada, France, Germany, Korea, Malaysia, New Zealand, Norway, Pakistan, Philippines, Portugal, Singapore, Sweden, Thailand and Vietnam

View recall →

Drug Recall Terminated Historical recordClass II

Cytarabine Injection, 20 mg/mL, 50 mL Single Dose Vial, Rx only, antineoplastic/cytotoxic agent; Manufactured for Hospira, Inc., Lake Forest, IL 60045, Product of Australia; NDC 61703-303-46

by Hospira Inc.

Reason
The affected lots of Carboplatin Injection, Cytarabine Injection, Methotrexate Injection, USP, and Paclitaxel Injection are being recalled due to visible particles embedded in the glass located at the neck of the vial. There may be the potential for product to come into contact with the embedded particles and the particles may become dislodged into the solution.
Recall initiated
June 27, 2012
Reported by FDA
September 26, 2012
Distribution
Nationwide, including Puerto Rico and Guam. Product was also distributed internationally to Australia, Belgium, Canada, France, Germany, Korea, Malaysia, New Zealand, Norway, Pakistan, Philippines, Portugal, Singapore, Sweden, Thailand and Vietnam

View recall →

Drug Recall Terminated Historical recordClass II

Carboplatin Injection, 10 mg/mL, 45 mL Multi-Dose Vial, Rx only, antineoplastic/cytotoxic agent; Manufactured for Hospira, Inc., Lake Forest, IL 60045, Product of Australia, NDC 61703-339-50 (Hospira label), NDC 61703-360-50 (Novoplus label)

by Hospira Inc.

Reason
The affected lots of Carboplatin Injection, Cytarabine Injection, Methotrexate Injection, USP, and Paclitaxel Injection are beig recalled due to visible particles embedded in the glass located at the neck of the vial. There may be the potential for product to come into contact with the embedded particles and the particles may become dislodged into the solution.
Recall initiated
June 27, 2012
Reported by FDA
September 26, 2012
Distribution
Nationwide, including Puerto Rico and Guam. Product was also distributed internationally to Australia, Belgium, Canada, France, Germany, Korea, Malaysia, New Zealand, Norway, Pakistan, Philippines, Portugal, Singapore, Sweden, Thailand and Vietnam

View recall →

Drug Recall Terminated Historical recordClass III

Pramipexole Dihydrochloride Tablets, 0.125 mg, 90-count tablets per bottle, Rx only, Manufactured in India by Sandoz Private Ltd., for Sandoz Inc., Princeton, NJ 08540, NDC 0781-5248-92

by Sandoz Incorporated

Reason
Impurities/Degradation Products: An out of specification result for a known impurity of the product occurred during 12 month stability testing.
Recall initiated
September 12, 2012
Reported by FDA
September 26, 2012
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass III

Pramipexole Dihydrochloride Tablets, 0.25 mg, 90-count tablets per bottle, Rx only, Manufactured in India by Sandoz Private Ltd., for Sandoz Inc., Princeton, NJ 08540, NDC 0781- 5249-92,

by Sandoz Incorporated

Reason
Impurities/Degradation Products: An out of specification result for a known impurity of the product occurred during 12 month stability testing.
Recall initiated
September 12, 2012
Reported by FDA
September 26, 2012
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass II

Dukal Corporation BZK Swab, First Aid Antiseptic, (Benzalkonium Chloride), 0.133% w/v, Item 854-1000 contains 1000 individually packaged swabs per box. Item 854 contains 200 individually packaged swabs per box. Packaging labeled with Dukal Corporation, Hauppauge, NY 11788 --- NDC 65517-00031

by Dukal Corp.

Reason
Microbial contamination of Non Sterile Product; contamination with Burkholderia cepacia (manufacturer)
Recall initiated
June 14, 2012
Reported by FDA
September 26, 2012
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.