ACCORD HEALTHCARE, INC.

91 FDA enforcement actions

91 Total Recalls

1 Class I

87 Class II

3 Class III

Firm Details

Product Types: drug
States: NC

All Recalls

Class II: Risk 09/16/2025 drug

Subpotent: During long term stability testing of Levothyroxine Sodium Tablets USP for 88 mcg, the assay content was observed below the approved specification range.
Class II: Risk 06/20/2025 drug

Subpotent Drug: Assay below the approved specification
Class II: Risk 06/20/2025 drug

Subpotent Drug: Assay below the approved specification
Class II: Risk 06/20/2025 drug

Subpotent Drug: Assay below the approved specification
Class II: Risk 06/20/2025 drug

Subpotent Drug: Assay below the approved specification
Class II: Risk 06/20/2025 drug

Subpotent Drug: Assay below the approved specification
Class II: Risk 06/20/2025 drug

Subpotent Drug: Assay below the approved specification
Class II: Risk 06/20/2025 drug

Subpotent Drug: Assay below the approved specification
Class II: Risk 04/10/2025 drug

Subpotent
Class II: Risk 04/10/2025 drug

Subpotent
Class II: Risk 04/10/2025 drug

Subpotent
Class II: Risk 04/10/2025 drug

Subpotent
Class II: Risk 11/08/2024 drug

Subpotent drug
Class II: Risk 10/10/2024 drug

CGMP Deviations: the presence of a nitrosamine impurity, N-nitroso-cinacalcet, above the acceptable daily intake (ADI) limits.
Class II: Risk 10/10/2024 drug

CGMP Deviations: the presence of a nitrosamine impurity, N-nitroso-cinacalcet, above the acceptable daily intake (ADI) limits.
Class II: Risk 10/10/2024 drug

CGMP Deviations: the presence of a nitrosamine impurity, N-nitroso-cinacalcet, above the acceptable daily intake (ADI) limits.
Class II: Risk 10/01/2024 drug

Failed Impurities/Degradation Specifications.
Class III: Low Risk 06/18/2024 drug

Subpotent drug: out of specification results
Class II: Risk 07/03/2023 drug

Presence of Particulate Matter: Particulate matter identified as fiber.
Class II: Risk 07/03/2023 drug

Presence of Particulate Matter: Particulate matter identified as fiber.
Class III: Low Risk 03/29/2023 drug

Sub-potent drug: assay test result below specifications at 9-month timepoint.
Class II: Risk 02/07/2023 drug

CGMP Deviations: recalling drug products following an FDA inspection.
Class II: Risk 02/07/2023 drug

CGMP Deviations: recalling drug products following an FDA inspection.
Class II: Risk 02/07/2023 drug

CGMP Deviations: recalling drug products following an FDA inspection.
Class II: Risk 02/07/2023 drug

CGMP Deviations: recalling drug products following an FDA inspection.
Class II: Risk 02/07/2023 drug

CGMP Deviations: recalling drug products following an FDA inspection.
Class II: Risk 02/07/2023 drug

CGMP Deviations: recalling drug products following an FDA inspection.
Class II: Risk 02/07/2023 drug

CGMP Deviations: recalling drug products following an FDA inspection.
Class II: Risk 02/07/2023 drug

CGMP Deviations: recalling drug products following an FDA inspection.
Class II: Risk 02/07/2023 drug

CGMP Deviations: recalling drug products following an FDA inspection.
Class II: Risk 02/07/2023 drug

CGMP Deviations: recalling drug products following an FDA inspection.
Class II: Risk 02/07/2023 drug

CGMP Deviations: recalling drug products following an FDA inspection.
Class II: Risk 02/07/2023 drug

CGMP Deviations: recalling drug products following an FDA inspection.
Class II: Risk 02/07/2023 drug

CGMP Deviations: recalling drug products following an FDA inspection.
Class II: Risk 02/07/2023 drug

CGMP Deviations: recalling drug products following an FDA inspection.
Class II: Risk 02/07/2023 drug

CGMP Deviations: recalling drug products following an FDA inspection.
Class II: Risk 02/07/2023 drug

CGMP Deviations: recalling drug products following an FDA inspection.
Class II: Risk 02/07/2023 drug

CGMP Deviations: recalling drug products following an FDA inspection.
Class II: Risk 02/07/2023 drug

CGMP Deviations: recalling drug products following an FDA inspection.
Class II: Risk 02/07/2023 drug

CGMP Deviations: recalling drug products following an FDA inspection.
Class II: Risk 02/07/2023 drug

CGMP Deviations: recalling drug products following an FDA inspection.
Class II: Risk 02/07/2023 drug

CGMP Deviations: recalling drug products following an FDA inspection.
Class II: Risk 02/07/2023 drug

CGMP Deviations: recalling drug products following an FDA inspection.
Class II: Risk 02/07/2023 drug

CGMP Deviations: recalling drug products following an FDA inspection.
Class II: Risk 02/07/2023 drug

CGMP Deviations: recalling drug products following an FDA inspection.
Class II: Risk 02/07/2023 drug

CGMP Deviations: recalling drug products following an FDA inspection.
Class II: Risk 02/07/2023 drug

CGMP Deviations: recalling drug products following an FDA inspection.
Class II: Risk 02/07/2023 drug

CGMP Deviations: recalling drug products following an FDA inspection.
Class II: Risk 02/07/2023 drug

CGMP Deviations: recalling drug products following an FDA inspection.
Class II: Risk 02/07/2023 drug

CGMP Deviations: recalling drug products following an FDA inspection.
Class II: Risk 02/07/2023 drug

CGMP Deviations: recalling drug products following an FDA inspection.
Class II: Risk 02/07/2023 drug

CGMP Deviations: recalling drug products following an FDA inspection.
Class II: Risk 02/07/2023 drug

CGMP Deviations: recalling drug products following an FDA inspection.
Class II: Risk 02/07/2023 drug

CGMP Deviations: recalling drug products following an FDA inspection.
Class II: Risk 02/07/2023 drug

CGMP Deviations: recalling drug products following an FDA inspection.
Class II: Risk 02/07/2023 drug

CGMP Deviations: recalling drug products following an FDA inspection.
Class II: Risk 02/07/2023 drug

CGMP Deviations: recalling drug products following an FDA inspection.
Class II: Risk 02/07/2023 drug

CGMP Deviations: recalling drug products following an FDA inspection.
Class II: Risk 02/07/2023 drug

CGMP Deviations: recalling drug products following an FDA inspection.
Class II: Risk 02/07/2023 drug

CGMP Deviations: recalling drug products following an FDA inspection.
Class II: Risk 02/07/2023 drug

CGMP Deviations: recalling drug products following an FDA inspection.
Class II: Risk 02/07/2023 drug

CGMP Deviations: recalling drug products following an FDA inspection.
Class II: Risk 02/07/2023 drug

CGMP Deviations: recalling drug products following an FDA inspection.
Class II: Risk 02/07/2023 drug

CGMP Deviations: recalling drug products following an FDA inspection.
Class II: Risk 02/07/2023 drug

CGMP Deviations: recalling drug products following an FDA inspection.
Class II: Risk 02/07/2023 drug

CGMP Deviations: recalling drug products following an FDA inspection.
Class II: Risk 02/07/2023 drug

CGMP Deviations: recalling drug products following an FDA inspection.
Class II: Risk 02/07/2023 drug

CGMP Deviations: recalling drug products following an FDA inspection.
Class II: Risk 02/07/2023 drug

CGMP Deviations: recalling drug products following an FDA inspection.
Class II: Risk 02/07/2023 drug

CGMP Deviations: recalling drug products following an FDA inspection.
Class II: Risk 02/07/2023 drug

CGMP Deviations: recalling drug products following an FDA inspection.
Class II: Risk 02/07/2023 drug

CGMP Deviations: recalling drug products following an FDA inspection.
Class II: Risk 02/07/2023 drug

CGMP Deviations: recalling drug products following an FDA inspection.
Class II: Risk 02/07/2023 drug

CGMP Deviations: recalling drug products following an FDA inspection.
Class II: Risk 02/07/2023 drug

CGMP Deviations: recalling drug products following an FDA inspection.
Class II: Risk 02/07/2023 drug

CGMP Deviations: recalling drug products following an FDA inspection.
Class II: Risk 02/07/2023 drug

CGMP Deviations: recalling drug products following an FDA inspection.
Class II: Risk 02/07/2023 drug

CGMP Deviations: recalling drug products following an FDA inspection.
Class II: Risk 02/07/2023 drug

CGMP Deviations: recalling drug products following an FDA inspection.
Class II: Risk 02/07/2023 drug

CGMP Deviations: recalling drug products following an FDA inspection.
Class II: Risk 02/07/2023 drug

CGMP Deviations: recalling drug products following an FDA inspection.
Class II: Risk 02/07/2023 drug

CGMP Deviations: recalling drug products following an FDA inspection.
Class II: Risk 02/07/2023 drug

CGMP Deviations: recalling drug products following an FDA inspection.
Class II: Risk 02/07/2023 drug

CGMP Deviations: recalling drug products following an FDA inspection.
Class II: Risk 02/07/2023 drug

CGMP Deviations: recalling drug products following an FDA inspection.
Class II: Risk 02/07/2023 drug

CGMP Deviations: recalling drug products following an FDA inspection.
Class II: Risk 02/07/2023 drug

CGMP Deviations: recalling drug products following an FDA inspection.
Class II: Risk 02/07/2023 drug

CGMP Deviations: recalling drug products following an FDA inspection.
Class II: Risk 01/12/2023 drug

Presence of Foreign Substance: Presence of a small piece of green plastic embedded in the crack towards the edge of the tablet.
Class I: Dangerous 11/29/2022 drug

Labeling mixup: cartons labeled as Daptomycin 350 mg/vial were found to contain vials of Daptomycin 500 mg per vial
Class III: Low Risk 01/28/2021 drug

Labeling; Label Mix-up; correctly labeled 2 mL vials were packaged into blister strips labeled for 1 mL vials

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.