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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 2,921–2,940 of 18,047 drug recalls

Drug Recall Ongoing Historical recordClass II

Finasteride Tablets, USP, 5 mg, packaged in: a) 30-count bottles (NDC 68788-6976-3); b) 90-count bottles (NDC 68788-6976-9), Rx only, Manufactured: Accord Healthcare, Inc., Durham, NC 27703.

by Preferred Pharmaceuticals, Inc.

Reason
cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection.
Recall initiated
March 23, 2023
Reported by FDA
April 12, 2023
Distribution
USA Nationwide

View recall →

Drug Recall Ongoing Historical recordClass II

Doxazosin Tablets, USP, 4 mg, 100-count bottle, Rx only, Manufactured: Accord Healthcare, Inc., Durham, NC 27703, NDC 68788-7149-1

by Preferred Pharmaceuticals, Inc.

Reason
cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection.
Recall initiated
March 23, 2023
Reported by FDA
April 12, 2023
Distribution
USA Nationwide

View recall →

Drug Recall Ongoing Historical recordClass II

Doxazosin Tablets, USP, 2 mg, 100-count bottle, Rx only, Manufactured: Accord Healthcare, Inc., Durham, NC 27703, NDC 68788-7328-1

by Preferred Pharmaceuticals, Inc.

Reason
cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection.
Recall initiated
March 23, 2023
Reported by FDA
April 12, 2023
Distribution
USA Nationwide

View recall →

Drug Recall Ongoing Historical recordClass II

Clopidogrel Tablets USP, 75 mg, 90-count bottles, Rx only, Manufactured: Accord Healthcare, Inc., Durham, NC 27703, NDC 68788-8190-9

by Preferred Pharmaceuticals, Inc.

Reason
cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection.
Recall initiated
March 23, 2023
Reported by FDA
April 12, 2023
Distribution
USA Nationwide

View recall →

Drug Recall Ongoing Historical recordClass II

Atorvastatin Calcium Tablets, USP, 20 mg, packaged in: a) 90-count bottle (NDC 68788-7631-9); b) 30-count bottle (NDC 68788-7631-3), Rx only, Manufactured: Accord Healthcare, Inc., Durham, NC 27703

by Preferred Pharmaceuticals, Inc.

Reason
cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection.
Recall initiated
March 23, 2023
Reported by FDA
April 12, 2023
Distribution
USA Nationwide

View recall →

Drug Recall Ongoing Historical recordClass II

Atorvastatin Calcium Tablets, USP, 10 mg, 90-count bottle, Rx only, Manufactured: Accord Healthcare, Inc., Durham, NC 27703, NDC 68788-7630-9

by Preferred Pharmaceuticals, Inc.

Reason
cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection.
Recall initiated
March 23, 2023
Reported by FDA
April 12, 2023
Distribution
USA Nationwide

View recall →

Drug Recall Terminated Historical recordClass III

Montelukast Sodium Oral Granules USP, 4 mg, packaged in a carton containing 30 packets, Rx only, Distributed By: Teva Pharmaceuticals USA, Inc., Parsippany, NJ 07054, Carton NDC 0093-7487-56, Packet NDC 0093-7487-19

by Teva Pharmaceuticals USA Inc

Reason
Failed Impurities/Degradation Specifications: failed impurities for Sulphoxide and Impurity A.
Recall initiated
March 27, 2023
Reported by FDA
April 12, 2023
Distribution
USA Nationwide

View recall →

Drug Recall Ongoing Historical recordClass II

Alprazolam C-IV, 2 mg, 60 Tabs per bottle, Rx only, Packaged and Distributed By: Direct Rx Dawsonville, GA 30534, NDC 72189-121-60.

by Direct Rx

Reason
CGMP Deviations: Repackaging firm recalling due to potential product cross contamination concerns at the manufacturer.
Recall initiated
March 22, 2023
Reported by FDA
April 12, 2023
Distribution
Nationwide in the USA

View recall →

Drug Recall Ongoing Historical recordClass II

Alprazolam C-IV, 1 mg, packaged in a) 30 Tabs per bottle, NDC 72189-213-30; b) 60 Tabs per bottle, NDC 72189-213-60; Rx only, Packaged and Distributed By: Direct Rx Dawsonville, GA 30534.

by Direct Rx

Reason
CGMP Deviations: Repackaging firm recalling due to potential product cross contamination concerns at the manufacturer.
Recall initiated
March 22, 2023
Reported by FDA
April 12, 2023
Distribution
Nationwide in the USA

View recall →

Drug Recall Ongoing Historical recordClass II

Alprazolam C-IV, 0.5 mg, 30 Tabs per bottle, Rx only, Packaged and Distributed By: Direct Rx Dawsonville, GA 30534, NDC 72189-0240-30.

by Direct Rx

Reason
CGMP Deviations: Repackaging firm recalling due to potential product cross contamination concerns at the manufacturer.
Recall initiated
March 22, 2023
Reported by FDA
April 12, 2023
Distribution
Nationwide in the USA

View recall →

Drug Recall Terminated Historical recordClass II

Alprazolam Tab, USP 1mg, (CIV), packaged in: a) 30-count bottle (NDC 68788-7596-3), b) 60-count bottle (NDC68788-7596-6); Rx Only, Preferred Pharmaceuticals, Inc. Manufactured by: Breckenridge Pharmaceuticals, Inc., Boca Raton, FL.

by Preferred Pharmaceuticals, Inc.

Reason
CGMP Deviations: Downstream recall from Breckenridge Pharmaceuticals, Inc due to potential risk of Cross Contamination.
Recall initiated
March 27, 2023
Reported by FDA
April 12, 2023
Distribution
Nationwide in the USA

View recall →

Drug Recall Terminated Historical recordClass II

Alprazolam Tab, USP 0.5mg, (CIV), packaged in: a) 30-count bottle (NDC 68788-7595-3), b) 60-count bottle (NDC 68788-7595-6), c) 90-count bottle (NDC 68788-7595-9); Rx Only, Preferred Pharmaceuticals, Inc. Manufactured by: Breckenridge Pharmaceuticals, Inc., Boca Raton, FL.

by Preferred Pharmaceuticals, Inc.

Reason
CGMP Deviations: Downstream recall from Breckenridge Pharmaceuticals, Inc due to potential risk of Cross Contamination.
Recall initiated
March 27, 2023
Reported by FDA
April 12, 2023
Distribution
Nationwide in the USA

View recall →

Drug Recall Terminated Historical recordClass II

Alprazolam Tab, USP 0.25mg, (CIV), 30-count bottle, Rx Only, Preferred Pharmaceuticals, Inc. Manufactured by: Breckenridge Pharmaceuticals, Inc., Boca Raton, FL. Ins:NDC 68788-7594-3

by Preferred Pharmaceuticals, Inc.

Reason
CGMP Deviations: Downstream recall from Breckenridge Pharmaceuticals, Inc due to potential risk of Cross Contamination.
Recall initiated
March 27, 2023
Reported by FDA
April 12, 2023
Distribution
Nationwide in the USA

View recall →

Drug Recall Terminated Historical recordClass II

Simvastatin 40 mg tablets, packaged in a) 30-count bottles (NDC 70518-0060-01) and b) 90-count bottles (NDC 70518-0060-00), Rx only, Repackaged by: RemedyRepack Inc., Indiana, PA 15701

by RemedyRePack Inc.

Reason
cGMP Deviations
Recall initiated
March 20, 2023
Reported by FDA
April 12, 2023
Distribution
RemedyRepack distributed product to consignees nationwide within the United States

View recall →

Drug Recall Terminated Historical recordClass II

Rosuvastatin 40mg tablets, packaged in a) 45-count bottles (NDC 70518-1311-01), and b) 90-count bottles (NDC 70518-0484-00), Rx only, Repackaged by: RemedyRepack Inc., Indiana, PA 15701.

by RemedyRePack Inc.

Reason
cGMP Deviations
Recall initiated
March 20, 2023
Reported by FDA
April 12, 2023
Distribution
RemedyRepack distributed product to consignees nationwide within the United States

View recall →

Drug Recall Terminated Historical recordClass II

Rosuvastatin 10mg tablets, packaged in a) 30-count bottles (NDC 70518-0375-03 and 70518-0375-01) and b) 90-count bottles (NDC 70518-0375-00), Rx only, Repackaged by: RemedyRepack Inc., Indiana, PA 15701.

by RemedyRePack Inc.

Reason
cGMP Deviations
Recall initiated
March 20, 2023
Reported by FDA
April 12, 2023
Distribution
RemedyRepack distributed product to consignees nationwide within the United States

View recall →

Drug Recall Terminated Historical recordClass II

Rosuvastatin 5mg tablets, 30-count bottles, Rx only, Repackaged by: RemedyRepack Inc., Indiana, PA 15701, NDC 70518-3519-00

by RemedyRePack Inc.

Reason
cGMP Deviations
Recall initiated
March 20, 2023
Reported by FDA
April 12, 2023
Distribution
RemedyRepack distributed product to consignees nationwide within the United States

View recall →

Drug Recall Terminated Historical recordClass II

Ropinirole 2mg tablets, packaged in 180-count bottles, Rx only, Repackaged by: RemedyRepack Inc., Indiana, PA 15701, NDC70518-2750-00

by RemedyRePack Inc.

Reason
cGMP Deviations
Recall initiated
March 20, 2023
Reported by FDA
April 12, 2023
Distribution
RemedyRepack distributed product to consignees nationwide within the United States

View recall →

Drug Recall Terminated Historical recordClass II

Atorvastatin 20 mg tablets, packaged in a) 30-count bottles (NDC 70518-1977-00) and b)90-count bottles (NDC 70518-1977-01), Rx only, Repackaged by: RemedyRepack Inc., Indiana, PA 15701.

by RemedyRePack Inc.

Reason
cGMP Deviations
Recall initiated
March 20, 2023
Reported by FDA
April 12, 2023
Distribution
RemedyRepack distributed product to consignees nationwide within the United States

View recall →

Drug Recall Terminated Historical recordClass II

Tadalafil 5 mg tablets, 30-count bottles, Rx only, Repackaged by: RemedyRepack Inc., Indiana, PA 15701, NDC 70518-2972-00

by RemedyRePack Inc.

Reason
cGMP Deviations
Recall initiated
March 20, 2023
Reported by FDA
April 12, 2023
Distribution
RemedyRepack distributed product to consignees nationwide within the United States

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.

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