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
rOPINIRole Tablets USP 3 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 16729-236-01, UPC 3 16729 23601 0 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
rOPINIRole Tablets USP 2 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 16729-235-01, UPC 3 16729 23501 3 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
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. 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
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. Published
March 8, 2023 Distribution
United States including Puerto Rico and…
View recall →
FDA Recall
Terminated Terminated: April 22, 2024 Historical record Class 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. 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
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. Published
March 8, 2023 Distribution
United States including Puerto Rico and…
View recall →
FDA Recall
Terminated Terminated: April 22, 2024 Historical record Class 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. 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
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. Published
March 8, 2023 Distribution
United States including Puerto Rico and…
View recall →
FDA Recall
Terminated Terminated: April 22, 2024 Historical record Class 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. Published
March 8, 2023 Distribution
United States including Puerto Rico and…
View recall →
FDA Recall
Terminated Terminated: April 22, 2024 Historical record Class 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. 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
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. Published
March 8, 2023 Distribution
United States including Puerto Rico and…
View recall →
FDA Recall
Terminated Terminated: April 22, 2024 Historical record Class 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. 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 .
