Skip to main content
Get Alerts

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.

Filters
Recall details
Location
Date range
Clear filters

Showing 2,801–2,820 of 17,937 drug recalls

Drug Recall Ongoing Historical recordClass II

Tadalafil Tablets, USP, 20 mg, 7-count bottle, Rx only, Manufactured for: Accord Healthcare, lnc., Durham, NC 27703, NDC 68788-8153-7

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

Simvastatin Tablets, USP, 40 mg, Packaged as: a) 90-count bottle (NDC 68788-9868-9); b) 60-count bottle (NDC 68788-9868-6); c) 30-count bottle (NDC 68788-9868-3), Rx only, Manufactured for: Accord Healthcare, lnc., 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

Simvastatin Tablets, USP, 20 mg, Packaged as: a) 90-count bottle (NDC 68788-9869-9); b) 60-count bottle (NDC 68788-9869-6); c) 30-count bottle (NDC 68788-9869-3), Rx only, Manufactured for: Accord Healthcare, lnc., 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

Simvastatin Tablets, USP, 80 mg, 90-count bottle, Rx only, Manufactured for: Accord Healthcare, lnc., Durham, NC 27703, NDC 68788-9429-9

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

Simvastatin Tablets, USP, 10 mg, 90-count bottle, Rx only, Manufactured for: Accord Healthcare, lnc., Durham, NC 27703, NDC 68788-9747-9

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

Pravastatin Sodium Tablets, USP, 20 mg, 90-count bottle, Rx only, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703, NDC 68788-8215-9

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

Rosuvastatin Tablets, USP, 5mg, 30-count bottle, Rx only, Manufactured: Accord Healthcare, Inc., Durham, NC 27703, NDC 68788-7971-3

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

Rosuvastatin Tablets, USP, 10 mg, Packaged as: a) 30-count bottle (NDC 68788-7086-3); b) 90-count bottle (NDC 68788-7086-9), 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

Montelukast Sodium Tablets, USP, 10 mg, packaged in: a) 30-count bottle (NDC 68788-9438-3); b) 60-count bottle (NDC 68788-9438-6); c) 90-count bottle (NDC 68788-9438-9), 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

Glimepiride Tablets, USP, 2 mg, 90-count bottle, Rx only, Manufactured: Accord Healthcare, Inc., Durham, NC 27703, NDC 68788-8095-9

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

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 →

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.