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 2,901–2,920 of 17,937 drug recalls

Drug Recall Terminated Historical recordClass II

rOPINIRole Tablets USP 1 mg*, 100-count bottle, Rx Only, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703 Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213 INDIA, NDC 16729-234-01, UPC 3 16729 23401 6

by ACCORD HEALTHCARE, INC.

Reason
CGMP Deviations: recalling drug products following an FDA inspection.
Recall initiated
February 7, 2023
Reported by FDA
March 8, 2023
Distribution
United States including Puerto Rico and Canada

View recall →

Drug Recall Terminated Historical recordClass II

rOPINIRole Tablets USP 0.5 mg*, 100-count bottle, Rx Only, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703 Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213 INDIA. NDC 16729-233-01, UPC 3 16729 23301 9

by ACCORD HEALTHCARE, INC.

Reason
CGMP Deviations: recalling drug products following an FDA inspection.
Recall initiated
February 7, 2023
Reported by FDA
March 8, 2023
Distribution
United States including Puerto Rico and Canada

View recall →

Drug Recall Terminated Historical recordClass II

Pravastatin Sodium Tablets USP, 80 mg, Rx Only, 90- count bottle, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703 Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213, INDIA, NDC 16729-011-15, UPC 3 16729 01115 0

by ACCORD HEALTHCARE, INC.

Reason
CGMP Deviations: recalling drug products following an FDA inspection.
Recall initiated
February 7, 2023
Reported by FDA
March 8, 2023
Distribution
United States including Puerto Rico and Canada

View recall →

Drug Recall Terminated Historical recordClass II

Pravastatin Sodium Tablets USP, 40 mg, Rx Only, 1,000-count bottle Manufactured for: Accord Healthcare, Inc., Durham, NC 27703 Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213, INDIA. NDC 16729-010-17, UPC 3 16729 01017 7

by ACCORD HEALTHCARE, INC.

Reason
CGMP Deviations: recalling drug products following an FDA inspection.
Recall initiated
February 7, 2023
Reported by FDA
March 8, 2023
Distribution
United States including Puerto Rico and Canada

View recall →

Drug Recall Terminated Historical recordClass II

Pravastatin Sodium Tablets USP 20 mg, Rx Only, 90-count bottle, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703 Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213, INDIA. NDC 16729-009-15, UPC 3 16729 00915 7.

by ACCORD HEALTHCARE, INC.

Reason
CGMP Deviations: recalling drug products following an FDA inspection.
Recall initiated
February 7, 2023
Reported by FDA
March 8, 2023
Distribution
United States including Puerto Rico and Canada

View recall →

Drug Recall Terminated Historical recordClass II

Pravastatin Sodium Tablets USP, 10 mg, Rx Only, Packaged as: a) 90-count bottle NDC 16729-008-15, UPC 3 16729 00815 0; b) 500-count bottle NDC 16729-008-16, UPC 3 16729 00816 7; Manufactured for: Accord Healthcare, Inc., Durham, NC 27703 Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213, INDIA

by ACCORD HEALTHCARE, INC.

Reason
CGMP Deviations: recalling drug products following an FDA inspection.
Recall initiated
February 7, 2023
Reported by FDA
March 8, 2023
Distribution
United States including Puerto Rico and Canada

View recall →

Drug Recall Terminated Historical recordClass II

Pirfenidone Tablets 801 mg, Rx Only, 90-count bottle, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703 Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213, INDIA. NDC 16729-468-15, UPC 3 16729 46815 2.

by ACCORD HEALTHCARE, INC.

Reason
CGMP Deviations: recalling drug products following an FDA inspection.
Recall initiated
February 7, 2023
Reported by FDA
March 8, 2023
Distribution
United States including Puerto Rico and Canada

View recall →

Drug Recall Terminated Historical recordClass II

Vigabatrin for Oral Solution, USP, 500 mg, Rx Only, 50-packets/carton, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703 Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213, INDIA. Packet NDC 16729-521-63, UPC 3 16729 52163 5; Carton NDC 16729-521-11, UPC 3 16729 52111 6.

by ACCORD HEALTHCARE, INC.

Reason
CGMP Deviations: recalling drug products following an FDA inspection.
Recall initiated
February 7, 2023
Reported by FDA
March 8, 2023
Distribution
United States including Puerto Rico and Canada

View recall →

Drug Recall Terminated Historical recordClass II

Tadalafil Tablets, USP, 20 mg, Rx Only, Packaged as: a) 30-count bottle NDC 16729-372-10, UPC 3 16729 37210 7; b) 500-count bottle NDC 16729-372-16, UPC 3 16729 37216 9; Manufactured for: Accord Healthcare, Inc., Durham, NC 27703. Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213 INDIA

by ACCORD HEALTHCARE, INC.

Reason
CGMP Deviations: recalling drug products following an FDA inspection.
Recall initiated
February 7, 2023
Reported by FDA
March 8, 2023
Distribution
United States including Puerto Rico and Canada

View recall →

Drug Recall Terminated Historical recordClass II

Tadalafil Tablets, USP 10 mg Rx Only, Packaged as: a) 30-count bottle NDC 16729-371-10, UPC 3 16729 37110 0; b) 500-count bottle NDC 16729-371-16, UPC 3 16729 37116 2; Manufactured for: Accord Healthcare, Inc., Durham, NC 27703. Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213 INDIA

by ACCORD HEALTHCARE, INC.

Reason
CGMP Deviations: recalling drug products following an FDA inspection.
Recall initiated
February 7, 2023
Reported by FDA
March 8, 2023
Distribution
United States including Puerto Rico and Canada

View recall →

Drug Recall Terminated Historical recordClass II

Tadalafil Tablets, USP, 5 mg Rx Only, Packaged as: a) 30-count bottle NDC 16729-370-10, UPC 3 16729 37010 3; b) 500-count bottle NDC 16729-370-16, UPC 3 16729 37016 5; Manufactured for: Accord Healthcare, Inc., Durham, NC 27703. Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213 INDIA

by ACCORD HEALTHCARE, INC.

Reason
CGMP Deviations: recalling drug products following an FDA inspection.
Recall initiated
February 7, 2023
Reported by FDA
March 8, 2023
Distribution
United States including Puerto Rico and Canada

View recall →

Drug Recall Terminated Historical recordClass II

Tadalafil Tablets, USP, 2.5 mg Rx Only, Packaged as: a) 30-count bottle NDC 16729-369-10, UPC 3 16729 36910 7; b) 500-count bottle NDC 16729-369-16, UPC 3 16729 36916 9; Manufactured for: Accord Healthcare, Inc., Durham, NC 27703. Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213 INDIA

by ACCORD HEALTHCARE, INC.

Reason
CGMP Deviations: recalling drug products following an FDA inspection.
Recall initiated
February 7, 2023
Reported by FDA
March 8, 2023
Distribution
United States including Puerto Rico and Canada

View recall →

Drug Recall Terminated Historical recordClass II

Succinylcholine Chloride Injection, USP, 200 mg/10 mL (20 mg/mL), 10 mL Multiple-dose vial in 10x10 carton, Rx Only, Manufactured for: Accord Healthcare, Inc. USA. Manufactured by: Intas Pharmaceuticals Limited, India, Vial NDC 16729-493-03, UPC 3 16729 49303 1; Carton NDC 16729-493-45, UPC 3 16729 49345 1.

by ACCORD HEALTHCARE, INC.

Reason
CGMP Deviations: recalling drug products following an FDA inspection.
Recall initiated
February 7, 2023
Reported by FDA
March 8, 2023
Distribution
United States including Puerto Rico and Canada

View recall →

Drug Recall Terminated Historical recordClass II

Simvastatin Tablets USP 80 mg Rx Only, Packaged as: a) 90-count bottle NDC 16729-007-15, UPC 3 16729 00715 3; b) 1,000-count bottle NDC 16729-007-17, UPC 3 16729 00717 7; Manufactured for: Accord Healthcare, Inc., Durham, NC 27703. Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213 INDIA

by ACCORD HEALTHCARE, INC.

Reason
CGMP Deviations: recalling drug products following an FDA inspection.
Recall initiated
February 7, 2023
Reported by FDA
March 8, 2023
Distribution
United States including Puerto Rico and Canada

View recall →

Drug Recall Terminated Historical recordClass II

Simvastatin Tablets USP 40 mg Rx Only, Packaged as: a) 90-count tablets NDC 16729-006-15, UPC 3 16729 00615 6; b) 1,000-count tablets NDC 16729-006-17, UPC 3 16729 00617 0; Manufactured for: Accord Healthcare, Inc., Durham, NC 27703. Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213 INDIA

by ACCORD HEALTHCARE, INC.

Reason
CGMP Deviations: recalling drug products following an FDA inspection.
Recall initiated
February 7, 2023
Reported by FDA
March 8, 2023
Distribution
United States including Puerto Rico and Canada

View recall →

Drug Recall Terminated Historical recordClass II

Simvastatin Tablets USP 20 mg Rx Only, Packaged as: a) 90-count bottle NDC 16729-005-15, UPC 3 16729 00515 9; b) 1,000-count bottle NDC 16729-005-17, UPC 3 16729 00517 3; Manufactured for: Accord Healthcare, Inc., Durham, NC 27703. Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213 INDIA

by ACCORD HEALTHCARE, INC.

Reason
CGMP Deviations: recalling drug products following an FDA inspection.
Recall initiated
February 7, 2023
Reported by FDA
March 8, 2023
Distribution
United States including Puerto Rico and Canada

View recall →

Drug Recall Terminated Historical recordClass II

Simvastatin Tablets, USP, 10 mg, Rx Only, Packaged as: a) 90-count bottle NDC 16729-004-15, UPC 3 16729 00415 2; b) 1,000-count bottle NDC 16729-004-17, UPC 3 16729 00417 6; Manufactured for: Accord Healthcare, Inc., Durham, NC 27703. Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213 INDIA

by ACCORD HEALTHCARE, INC.

Reason
CGMP Deviations: recalling drug products following an FDA inspection.
Recall initiated
February 7, 2023
Reported by FDA
March 8, 2023
Distribution
United States including Puerto Rico and Canada

View recall →

Drug Recall Terminated Historical recordClass II

Simvastatin Tablets USP 5 mg Rx Only, Packaged as: a) 90-count bottle NDC 16729-156-15, UPC 3 16729 15615 8; b) 1,000-count bottle NDC 16729-156-17, UPC 3 16729 15617 2; Manufactured for: Accord Healthcare, Inc., Durham, NC 27703. Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213 INDIA

by ACCORD HEALTHCARE, INC.

Reason
CGMP Deviations: recalling drug products following an FDA inspection.
Recall initiated
February 7, 2023
Reported by FDA
March 8, 2023
Distribution
United States including Puerto Rico and Canada

View recall →

Drug Recall Terminated Historical recordClass II

Rosuvastatin Tablets, USP 40 mg* Rx Only, Packaged as: a) 30-count bottle NDC 16729-287-10, UPC 3 16729 28710 4; b) 90-count bottle NDC 16729-287-15, UPC 3 16729 28715 9; c) 1,000-count bottle NDC 16729-287-17, UPC 3 16729 28717 3; Manufactured for: Accord Healthcare, Inc., Durham, NC 27703. Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213 INDIA

by ACCORD HEALTHCARE, INC.

Reason
CGMP Deviations: recalling drug products following an FDA inspection.
Recall initiated
February 7, 2023
Reported by FDA
March 8, 2023
Distribution
United States including Puerto Rico and Canada

View recall →

Drug Recall Terminated Historical recordClass II

Rosuvastatin Tablets, USP 20 mg* Rx Only, Packaged as: a) 90-count bottle NDC 16729-286-15, UPC 3 16729 28615 2; b) 1,000-count bottles NDC 16729-286-17, UPC 3 16729 28617 6; Manufactured for: Accord Healthcare, Inc., Durham, NC 27703. Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213 INDIA

by ACCORD HEALTHCARE, INC.

Reason
CGMP Deviations: recalling drug products following an FDA inspection.
Recall initiated
February 7, 2023
Reported by FDA
March 8, 2023
Distribution
United States including Puerto Rico and Canada

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.