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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 2,941–2,960 of 17,937 drug recalls

Drug Recall Terminated Historical recordClass II

Dofetilide Capsules, 125 mcg (0.125 mg), 60-count bottle, Rx only, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703. Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213, INDIA, NDC 16729-490-12 UPC 3 16729 49012 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

Daptomycin for Injection 500 mg per vial, Single-dose vial, Rx only, Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213, INDIA. NDC 16729-435-05 UPC 3 16729 43505 5.

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

Daptomycin for Injection 350 mg/vial, Rx only, Packaged as: a) Single-dose vial NDC 16729-434-05 UPC 3 16729 43405 8; b) 10 Single-dose vials NDC 16729-434-45 UPC 3 16729 43445 4 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

Clopidogrel Tablets USP, 75 mg, Rx Only, Packaged in a) 30-count bottles NDC 16729-218-10 UPC 3 16729 21810 8; b) 90-count bottles NDC 16729-218-15 UPC 3 16729 21815 3; c) 500-count bottles, NDC 16729-218-16, UPC 3 16729 21816 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

BusPIRone Hydrochloride Tablets USP, 10 mg 500-count bottle, Rx Only, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703 Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213, INDIA, NDC 16729-202-16 UPC 3 16729 20216 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

BusPIRone Hydrochloride Tablets USP 15 mg, Rx Only, 100-count bottle, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703 Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213, INDIA, NDC 16729-203-01, UPC 3 16729 20301 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

BusPIRone Hydrochloride Tablets USP, 5 mg, Rx Only, Packaged as: a) 100 Tablets NDC 16729-200-01 UPC 3 16729 20001 1; b) 500 Tablets NDC 16729-200-16 UPC 3 16729 20016 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

BusPIRone Hydrochloride Tablets USP 7.5 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 16729-201-01

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

Atorvastatin Calcium Tablets USP 20 mg* Rx Only, Packaged as a) 90 Tablets NDC 16729-045-15 UPC 3 16729 04515 5; b) 1,000 Tablets NDC 16729-045-17 UPC 3 16729 04517 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

Atorvastatin Calcium Tablets USP, 10 mg* Rx Only, Packaged as a) 90 Tablets NDC 16729-044-15 UPC 3 16729 04415 8; b) 1,000 Tablets NDC 16729-044-17 UPC 3 16729 04417 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

Aripiprazole Tablets, USP 30 mg Rx Only, a) 30-count bottle, NDC 16729-283-10, UPC 3 16729 28310 6; b) 100-count bottle, NDC 16729-283-01, UPC 3 16729 28301 4; 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

Aripiprazole Tablets, USP 20 mg Rx Only, packaged as, a) 30-count bottle, NDC 16729-282-10, UPC 3 16729 28210 9; b) 100-count bottle, NDC 16729-282-01, UPC 3 16729 28201 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

Aripiprazole Tablets, USP 15 mg Rx Only, Packaged as: a) 30-count bottle NDC 16729-281-10, UPC 3 16729 28110 2; b) 100-count bottle NDC 16729-281-01, UPC 3 16729 28101 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

Aripiprazole Tablets, USP 10 mg Rx Only, Packaged as a) 30-count bottle, NDC 16729-280-10, UPC 3 16729 28010 5; b) 100-count bottle, NDC 16729-280-01, UPC 3 16729 28001 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

Aripiprazole Tablets, USP 5 mg Rx Only, Packaged as a) 30-count bottle, NDC 16729-279-10, UPC 3 16729 27910 9; b) 100-count bottle, NDC 16729-279-01, UPC 3 16729 27901 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

Aripiprazole Tablets, USP 2 mg, Rx Only, Packaged as a) 30-count bottle, NDC 16729-278-10, UPC 3 16729 27810 2; b) 100-count bottle, NDC 16729-278-01, UPC 3 16729 27801 10 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

Sterile Water for Injection, USP, 30x5 mL Single-Dose Vials, Rx Only, Nephron 4500 12th Street Extension West Columbia, SC 29172, NDC 0487-6105-01

by Nephron Sc Inc

Reason
CGMP Deviations: Potential product carryover.
Recall initiated
February 23, 2023
Reported by FDA
March 8, 2023
Distribution
United States

View recall →

Drug Recall Terminated Historical recordClass III

Fentanyl 1,500 mcg/30 mL syringe, Injection for Intravenous Use, Concentration = 50 mcg/mL, Preservative Free, Rx Only, Single Dose Container, SCA Pharmaceuticals, Windsor CT 06095, NDC# 70004-0200-16.

by SCA Pharmaceuticals

Reason
Subpotent Drug
Recall initiated
February 24, 2023
Reported by FDA
March 8, 2023
Distribution
Nationwide in the US.

View recall →

Drug Recall Terminated Historical recordClass II

Phenylephrine HCl in 0.9% Sodium Chloride Injection, USP, 50 mg/250 mL (200 mcg/mL), 250 mL Single-Dose Container bottle, packaged in 15 x 1 IV Bottles per carton, Rx Only, Nephron 503B Outsourcing Facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC 69374-321-25.

by Nephron Sterile Compounding Center LLC

Reason
Lack of Assurance of Sterility
Recall initiated
February 22, 2023
Reported by FDA
March 8, 2023
Distribution
Nationwide in the USA

View recall →

Drug Recall Terminated Historical recordClass II

Phenylephrine HCl Injection, USP, 0.8 mg/10 mL (80 mcg/mL), 10 mL Single-Dose Vial, packaged in 30 x 10 mL Single-Dose Vials per carton, 12 x 30 Vials Carton per case, Rx Only, Nephron 503B Outsourcing Facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC 69374-301-10.

by Nephron Sterile Compounding Center LLC

Reason
Lack of Assurance of Sterility
Recall initiated
February 22, 2023
Reported by FDA
March 8, 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.