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
Ongoing Historical record Class II
Levothyroxine Sodium Tablets, USP, 25 mcg (0.025 mg), 1000 bottles, Rx Only, Manufactured for Accord Healthcare, Inc., Raleigh, NC 27617, Manufactured by: Intas Pharmaceuticals Limited, Camp Road, Selaqui, Dehradun-248 197, INDIA, NDC 16729-447-17 by ACCORD HEALTHCARE, INC.
Reason
Subpotent Published
May 7, 2025 Distribution
Nationwide
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FDA Recall
Ongoing Historical record Class II
Levothyroxine Sodium Tablets, USP, 75 mcg (0.075 mg), 1000-count bottle, Rx Only, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703, Manufactured by: Intas Pharmaceuticals Limited, Camp Road, Selaqui, Dehradun-248 197, INDIA, NDC 16729-449-17 by ACCORD HEALTHCARE, INC.
Reason
Subpotent drug Published
December 11, 2024 Distribution
Nationwide
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FDA Recall
Ongoing Historical record Class II
Cinacalcet Tablets, 90 mg, Rx Only, a) 30 Tablets per bottle, NDC: 16729-442-10, b) 90 Tablets per bottle, NDC: 16729-442-15, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703. Manufactured by: Intas Pharmaceuticals Limited, Ahmedabad - 382 210, INDIA. by ACCORD HEALTHCARE, INC.
Reason
CGMP Deviations: the presence of a nitrosamine impurity, N-nitroso-cinacalcet, above the acceptable daily intake (ADI) limits. Published
November 6, 2024 Distribution
Nationwide
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FDA Recall
Ongoing Historical record Class II
Cinacalcet Tablets, 60 mg, Rx Only, a) 30 Tablets per bottle, NDC: 16729-441-10, b) 90 Tablets per bottle, NDC: 16729-441-15, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703. Manufactured by: Intas Pharmaceuticals Limited, Ahmedabad - 382 210, INDIA. by ACCORD HEALTHCARE, INC.
Reason
CGMP Deviations: the presence of a nitrosamine impurity, N-nitroso-cinacalcet, above the acceptable daily intake (ADI) limits. Published
November 6, 2024 Distribution
Nationwide
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FDA Recall
Ongoing Historical record Class II
Cinacalcet Tablets 30 mg, Rx Only, a) 30 Tablets per bottle, NDC: 16729-440-10, b) 90 Tablets per bottle, NDC: 16729-440-15, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703, Manufactured by: Intas Pharmaceuticals Limited, Ahmedabad - 382 210, INDIA. by ACCORD HEALTHCARE, INC.
Reason
CGMP Deviations: the presence of a nitrosamine impurity, N-nitroso-cinacalcet, above the acceptable daily intake (ADI) limits. Published
November 6, 2024 Distribution
Nationwide
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FDA Recall
Terminated Terminated: February 23, 2026 Historical record Class II
Cisplatin Injection, 100mg/100mL (1mg/mL), For Intravenous Use, 100 mL Multiple Dose Vial, Rx Only, Manufactured for: Accord Healthcare Inc., Durham, NC 27703. Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad 382 213, India. Mfg. Lic. No.: G/28/1336, NDC 16729-288-38 by ACCORD HEALTHCARE, INC.
Reason
Failed Impurities/Degradation Specifications. Published
October 23, 2024 Distribution
Nationwide
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FDA Recall
Terminated Terminated: February 12, 2026 Historical record Class III
Dodex Injectable (Cyanocobalamin Injection) USP, 1,000mcg/mL, 1mL multiple dose vial, Rx only, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703, Manufactured by: Intas Pharmaceuticals Limited, Ahmedabad-382 210, India, NDC 16729-533-08, UPC Code: 031672953308 by ACCORD HEALTHCARE, INC.
Reason
Subpotent drug: out of specification results Published
July 10, 2024 Distribution
Nationwide
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FDA Recall
Terminated Terminated: October 17, 2024 Historical record Class II
Bivalirudin for Injection 250 mg, 10 Single-Dose Vials, Rx Only, Manufactured for: Accord Healthcare, Inc. Durham, NC 27703 Manufactured by: Intas Pharmaceuticals Limited Ahmedabad-382 210, India, NDC 16729-275-67. by ACCORD HEALTHCARE, INC.
Reason
Presence of Particulate Matter: Particulate matter identified as fiber. Published
July 19, 2023 Distribution
Nationwide
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FDA Recall
Terminated Terminated: October 17, 2024 Historical record Class II
Atropine Sulfate Injection, USP 8 mg per 20 mL (0.4 mg per mL), 20 mL Multiple Dose Vials, Rx only, Manufactured for: Accord Healthcare, Inc. Durham, NC 27703 Manufactured by: Intas Pharmaceuticals Limited Ahmedabad-382 210, India, NDC 16729-512-43. by ACCORD HEALTHCARE, INC.
Reason
Presence of Particulate Matter: Particulate matter identified as fiber. Published
July 19, 2023 Distribution
Nationwide
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FDA Recall
Terminated Terminated: March 19, 2025 Historical record Class III
Dodex Injectable Cyanocobalamin Injection, USP 1,000 mcg/mL, 25 x1 ML Multiple dose vials, For Intramuscular or Subcutaneous Use Only, Rx Only, Sterile, Manufactured by: Intas Pharmaceuticals Limited Pharmaz Ahnedabad 382 213, INDIA, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703, NDC 16729-533-08. by ACCORD HEALTHCARE, INC.
Reason
Sub-potent drug: assay test result below specifications at 9-month timepoint. Published
April 12, 2023 Distribution
Nationwide
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FDA Recall
Terminated Terminated: April 22, 2024 Historical record Class II
rOPINIRole Tablets USP 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 16729-238-01, UPC 3 16729 23801 4 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 4 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 16729-237-01, UPC 3 16729 23701 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 →
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 .
