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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 17,937 drug recalls

Drug Recall Terminated Historical recordClass II

Rosuvastatin Tablets, USP, 10 mg*, Rx Only, Packaged as: a) 90-count bottle, NDC 16729-285-15, UPC 3 16729 28515 5; b) 1,000-count bottle NDC 16729-285-17, UPC 3 16729 28517 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

Rosuvastatin Tablets, USP, 5 mg*, Rx Only, Packaged as: a) 90-count bottle, NDC 16729-284-15, UPC 3 16729 28415 8; b) 1,000-count bottle, NDC 16729-284-17, UPC 3 16729 28417 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

Phenylephrine Hydrochloride Injection, USP 100 mg/10 mL (10 mg/mL), Rx Only, 10 mL Vial, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703 Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213, INDIA; NDC 16729-466-03, UPC 3 16729 46603 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

Phenylephrine Hydrochloride Injection, USP, 50 mg/5mL (10 mg/mL), Rx Only, 5 mL Vial, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703 Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213, INDIA; Vial NDC 16729-465-31, UPC 3 16729 46531 1; Carton NDC 16729-465-03, UPC 3 16729 46503 8

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

Phenylephrine Hydrochloride Injection, USP 10 mg/mL Rx Only, 1 mL Single Dose Vial, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703 Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213, INDIA; Vial NDC 16729-464-63, UPC 3 16729 46463 5; Carton NDC 16729-464-08, UPC 3 16729 46408 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

Glycopyrrolate Injection, USP 4 mg/20 mL (0.2 mg/mL) 20 mL Multiple Dose Vial, 10vial carton, Rx Only, Manufactured for: Accord Healthcare, Inc. Durham, NC 27703, USA. Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213, INDIA 20mL vial NDC 16729-474-05 UPC 3 16729 47405 4;carton NDC 16729-474-03 UPC 3 16729 47403 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

Glycopyrrolate Injection, USP 1 mg/5 mL (0.2 mg/mL) 5 mL Multiple Dose Vial, x 10 vials carton, Rx Only, Manufactured for: Accord Healthcare, Inc. Durham, NC 27703, USA. Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213, INDIA 5mL vial NDC 16729-473-31 UPC 3 16729 47331 6; carton NDC 16729-473-03 UPC 3 16729 47303 3

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

Glycopyrrolate Injection, USP, 0.4 mg/2 mL (0.2 mg/mL) 2 mL Single Dose Vial X 25 vials carton, Rx Only, Manufactured for: Accord Healthcare, Inc. Durham, NC 27703, USA. Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213, INDIA 2 ML vial NDC 16729-472-30 UPC 3 16729 47230 2; carton NDC 16729-472-08 UPC 3 16729 47208 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

Glycopyrrolate Injection, USP, 0.2 mg/mL, 1 mL Single Dose Vial x 25 vials, Rx Only, Manufactured for: Accord Healthcare, Inc. Durham, NC 27703, USA. Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213, INDIA 1 ml vial NDC 16729-471-63 UPC 3 16729 47163 3; 25 x 1 mL carton NDC 16729-471-08 UPC 3 16729 47108 4

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

Glimepiride Tablets USP, 4 mg, Rx Only, Packaged in: a) 100-count bottle NDC 16729-003-01 UPC 3 16729 00301 8; b) 500-count NDC 16729-003-16 UPC 3 16729 00316 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

Glimepiride Tablets USP, 2 mg, Rx Only, Packaged in: a) 100 Tablets NDC 16729-002-01 UPC 3 16729 00201 1; b) 500 Tablets NDC 16729-002-16 UPC 3 16729 00216 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

Glimepiride Tablets USP, 1 mg, Rx Only, Packaged in: a) 100-count bottle NDC 16729-001-01 UPC 3 16729 00101 4; b) 500-count bottle NDC 16729-001-16 UPC 3 16729 00116 8; 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

Finasteride Tablets USP, 5 mg, Rx Only, Packaged as: a) 30-count bottles NDC 16729-090-10 UPC 3 16729 09010 0; b) 90-count bottles NDC 16729-090-15 UPC 3 16729 09015 5; c) 100-count bottles NDC 16729-090-01 UPC 3 16729 09001 8; d) 500-count bottles NDC 16729-090-16 UPC 3 16729 09016 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

Finasteride Tablets USP 1 mg, 90-count bottle, Keeps, Rx Only, Manufactured for: Thirty Madison, Inc. New York, NY 10016 Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213, INDIA, NDC 71713-096-90 UPC 3 71713 09690 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

Finasteride Tablets USP, 1 mg, Rx Only, Packaged as: a) 30-count bottle NDC 16729-089-10 UPC 3 16729 08910 4; b) 90-count bottle NDC 16729-089-15 UPC 3 16729 08915 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

Doxazosin Tablets USP, 8 mg, Rx Only, Packaged in: a) 100 Tablets NDC 16729-415-01 UPC 3 16729 41501 9; b) 1,000 Tablets NDC 16729-415-17 UPC 3 16729 41517 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

Doxazosin Tablets USP, 4 mg, Rx Only, Packaged as: a) 100-count bottle NDC 16729-213-01 UPC 3 16729 21301 1; b) 1,000-count bottle NDC 16729-213-17 UPC 3 16729 21317 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

Doxazosin Tablets USP, 2 mg, Rx Only, Packaged as: a) 100-count bottle NDC 16729-414-01 UPC 3 16729 41401 2; b) 1,000-count NDC 16729-414-17 UPC 3 16729 41417 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

Doxazosin Tablets USP 1 mg, Rx Only, Packaged as: a) 100-count bottle NDC 16729-211-01 UPC 3 16729 21101 7; b) 1,000-count bottle NDC 16729-211-17 UPC 3 16729 21117 8; 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

Dofetilide Capsules 500 mcg (0.5 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 16729-492-12 UPC 3 16729 49212 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 →

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.