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
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. 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 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. 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
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. Published
March 8, 2023 Distribution
United States including Puerto Rico and…
View recall →
FDA Recall
Terminated Terminated: April 22, 2024 Historical record Class 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. 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
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. 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
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. Published
March 8, 2023 Distribution
United States including Puerto Rico and…
View recall →
FDA Recall
Terminated Terminated: April 22, 2024 Historical record Class 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. Published
March 8, 2023 Distribution
United States including Puerto Rico and…
View recall →
FDA Recall
Terminated Terminated: April 22, 2024 Historical record Class 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. Published
March 8, 2023 Distribution
United States including Puerto Rico and…
View recall →
FDA Recall
Terminated Terminated: April 22, 2024 Historical record Class 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. Published
March 8, 2023 Distribution
United States including Puerto Rico and…
View recall →
FDA Recall
Terminated Terminated: April 22, 2024 Historical record Class 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. Published
March 8, 2023 Distribution
United States including Puerto Rico and…
View recall →
FDA Recall
Terminated Terminated: April 22, 2024 Historical record Class II
rOPINIRole Tablets USP 0.25 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 16729-232-01, UPC 3 16729 23201 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
Pirfenidone Tablets 267 mg 90-count bottle x3/Carton, Rx Only, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703 Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213, INDIA. Bottle NDC 16729-467-15, UPC 3 16729 46715 5; Carton NDC 16729-467-85, UPC 3 16729 46785 8. 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 .
