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
Montelukast Sodium Tablets, USP, 10 mg* Rx Only, Packaged as: a) 30-count bottle NDC 16729-119-10 UPC 3 16729 11910 8; b) 90-count bottle NDC 16729-119-15 UPC 3 16729 11915 3; c) 1,000-count bottle NDC 16729-119-17 UPC 3 16729 11917 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…
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FDA Recall
Terminated Terminated: April 22, 2024 Historical record Class II
Dofetilide Capsules 250 mcg (0.25 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 16729-491-12 UPC 3 16729 49112 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 30 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 16729-289-12 UPC 3 16729 28912 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
Atorvastatin Calcium Tablets USP 80 mg* Rx Only, Packaged as a) 90 Tablets NDC 16729-047-15 UPC 3 16729 04715 9; b) 500 Tablets NDC 16729-047-16 UPC 3 16729 04716 6; 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
Atorvastatin Calcium Tablets USP 40 mg* Rx Only, Packaged as a) 90 Tablets NDC 16729-046-15 UPC 3 16729 04615 2; b) 1,000 Tablets NDC 16729-046-17 UPC 3 16729 04617 6, 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 23, 2024 Historical record Class II
Allopurinol Tablets USP, 100 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 16729-134-01 by ACCORD HEALTHCARE, INC.
Reason
Presence of Foreign Substance: Presence of a small piece of green plastic embedded in the crack towards the edge of the tablet. Published
February 1, 2023 Distribution
Nationwide
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FDA Recall
Terminated Terminated: February 22, 2024 Historical record Class I
Daptomycin for Injection 350 mg/vial 1 Single-dose vial, Rx only, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703 Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213, India. NDC 16729-0434-05 by ACCORD HEALTHCARE, INC.
Reason
Labeling mixup: cartons labeled as Daptomycin 350 mg/vial were found to contain vials of Daptomycin 500 mg per vial Published
January 25, 2023 Distribution
Nationwide
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FDA Recall
Terminated Terminated: February 8, 2022 Historical record Class III
Glycopyrrolate Injection, USP 0.4 mg/2 mL (0.2 mg/mL) 25 x 2 mL Single Dose Vials Rx Only, Manufactured for: Accord Healthcare, Inc. Durham, NC 27703, USA. Manufactured by: Intas Pharmaceuticals Limited, Ahmedabad-382 210, India NDC 16729-472-08 (Vial NDC 16729-472-30) by ACCORD HEALTHCARE, INC.
Reason
Labeling; Label Mix-up; correctly labeled 2 mL vials were packaged into blister strips labeled for 1 mL vials Published
February 17, 2021 Distribution
Nationwide
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FDA Recall
Terminated Terminated: May 7, 2020 Historical record Class I
Hydrochlorothiazide Tablets USP, 12.5 mg, 100-count bottle, Rx Only, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703; Manufactured by: Intas Pharmaceuticals Limited, Ahmedabad - 382 210, India; NDC 16729-182-01. by ACCORD HEALTHCARE, INC.
Reason
Product Mix-Up: customer complaint that a sealed bottle labeled as Hydrochlorothiazide Tablets USP 12.5 mg contained only Spironolactone Tablets USP 25 mg. Published
September 19, 2018 Distribution
Nationwide
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FDA Recall
Terminated Terminated: August 2, 2017 Historical record Class II
Lisinopril tablets, 5 mg, 1000-count bottle, Rx only, Manufactured for Accord Healthcare, Inc., Durham, NC 27703, NDC 16729-376-17 by ACCORD HEALTHCARE, INC.
Reason
Failed tablet/capsule specification: missing break line on the 5mg tablet. Published
February 22, 2017 Distribution
Nationwide
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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.
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