ACCORD HEALTHCARE, INC.
29 ongoing recalls and 77 historical records
Based on the official records currently available to Public Health Trace, 29 recalls naming ACCORD HEALTHCARE, INC. are currently shown as ongoing. The other 77 records below are historical.
Public Health Trace has 106 recalls naming ACCORD HEALTHCARE, INC. as the recalling firm, republished from official FDA and USDA sources.
Recall records - 106 total Recalls by year
A bar chart of the number of recalls naming this company by year.
Recalls by year
Year Recalls 2023 69 2024 6 2025 12 2026 13
Download CSV FDA Recall
Terminated Terminated: April 22, 2024 Historical record Class 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. Published
March 8, 2023 Distribution
United States including Puerto Rico and…
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FDA Recall
Terminated Terminated: April 22, 2024 Historical record Class 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. Published
March 8, 2023 Distribution
United States including Puerto Rico and…
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FDA Recall
Terminated Terminated: April 22, 2024 Historical record Class 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. Published
March 8, 2023 Distribution
United States including Puerto Rico and…
View recall →
FDA Recall
Terminated Terminated: April 22, 2024 Historical record Class 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. Published
March 8, 2023 Distribution
United States including Puerto Rico and…
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FDA Recall
Terminated Terminated: April 22, 2024 Historical record Class 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. Published
March 8, 2023 Distribution
United States including Puerto Rico and…
View recall →
FDA Recall
Terminated Terminated: April 22, 2024 Historical record Class 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. Published
March 8, 2023 Distribution
United States including Puerto Rico and…
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FDA Recall
Terminated Terminated: April 22, 2024 Historical record Class 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. Published
March 8, 2023 Distribution
United States including Puerto Rico and…
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FDA Recall
Terminated Terminated: April 22, 2024 Historical record Class 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. Published
March 8, 2023 Distribution
United States including Puerto Rico and…
View recall →
FDA Recall
Terminated Terminated: April 22, 2024 Historical record Class 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. Published
March 8, 2023 Distribution
United States including Puerto Rico and…
View recall →
FDA Recall
Terminated Terminated: April 22, 2024 Historical record Class 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. Published
March 8, 2023 Distribution
United States including Puerto Rico and…
View recall →
FDA Recall
Terminated Terminated: April 22, 2024 Historical record Class 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. Published
March 8, 2023 Distribution
United States including Puerto Rico and…
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FDA Recall
Terminated Terminated: April 22, 2024 Historical record Class 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. Published
March 8, 2023 Distribution
United States including Puerto Rico and…
View recall →
Some FDA recall records on this page come from FDA's Enforcement Report database .
Not every Enforcement Report record has a separate FDA.gov recall-announcement page.
This page lists recalls that name ACCORD HEALTHCARE, INC. as the recalling firm in the official source notice. It is
not a safety rating, ranking, or statement that the company acted negligently.
Read the full medical disclaimer .
