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ACCORD HEALTHCARE Recalls
94 recalls on record · February 22, 2017 to July 8, 2026 · Drugs
Recalls by year
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21
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24
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26
Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
July 8, 2026DrugsFDA
ACCORD HEALTHCARE, INC. recalls Levothyroxine Sodium Tablets, USP, 300 mcg (0.3mg), 90 Tablets bottles, Rx only, Manufactured for: Accord Healthcare, In
Hazard: Subpotent Drug
October 15, 2025DrugsFDA
ACCORD HEALTHCARE, INC. recalls Levothyroxine Sodium Tablets, USP, 88 mcg (0.088 mg), 90 Tablets per bottle, Rx Only, Manufactured for Accord Healthcare
Hazard: Subpotent: During long term stability testing of Levothyroxine Sodium Tablets USP for 88 mcg, the assay content was observed below the approved specification range.
July 23, 2025DrugsFDA
ACCORD HEALTHCARE, INC. recalls Levothyroxine Sodium Tablets, USP, 175 mcg (0.175 mg), 1000-count bottle, Rx Only, Manufactured for: Accord Healthcare,
Hazard: Subpotent Drug: Assay below the approved specification
July 23, 2025DrugsFDA
ACCORD HEALTHCARE, INC. recalls Levothyroxine Sodium Tablets, USP, 150 mcg (0.15 mg), 1000-count bottle, Rx Only, Manufactured for: Accord Healthcare, I
Hazard: Subpotent Drug: Assay below the approved specification
July 23, 2025DrugsFDA
ACCORD HEALTHCARE, INC. recalls Levothyroxine Sodium Tablets, USP, 112 mcg (0.112 mg), 1000-count bottle, Rx Only, Manufactured for: Accord Healthcare,
Hazard: Subpotent Drug: Assay below the approved specification
July 23, 2025DrugsFDA
ACCORD HEALTHCARE, INC. recalls Levothyroxine Sodium Tablets, USP, 100 mcg (0.1 mg), 1000-count bottle, Rx Only, Manufactured for: Accord Healthcare, In
Hazard: Subpotent Drug: Assay below the approved specification
July 23, 2025DrugsFDA
ACCORD HEALTHCARE, INC. recalls Levothyroxine Sodium Tablets, USP, 50 mcg (0.05 mg), 90-count bottle, Rx Only, Manufactured for: Accord Healthcare, Inc.
Hazard: Subpotent Drug: Assay below the approved specification
July 23, 2025DrugsFDA
ACCORD HEALTHCARE, INC. recalls Levothyroxine Sodium Tablets, USP, 25 mcg (0.025 mg), 1000-count bottle, Rx Only, Manufactured for: Accord Healthcare, I
Hazard: Subpotent Drug: Assay below the approved specification
July 23, 2025DrugsFDA
ACCORD HEALTHCARE, INC. recalls Levothyroxine Sodium Tablets, USP, 25 mcg (0.025 mg), 90-count bottle, Rx Only, Manufactured for: Accord Healthcare, Inc
Hazard: Subpotent Drug: Assay below the approved specification
May 7, 2025DrugsFDA
ACCORD HEALTHCARE, INC. recalls Levothyroxine Sodium Tablets, USP, 112 mcg (0.112 mg), 90 bottles, Rx Only, Manufactured for Accord Healthcare, Inc., Ra
Hazard: Subpotent
May 7, 2025DrugsFDA
ACCORD HEALTHCARE, INC. recalls Levothyroxine Sodium Tablets, USP, 88 mcg (0.088 mg), 1000 bottles, Rx Only, Manufactured for Accord Healthcare, Inc., R
Hazard: Subpotent
May 7, 2025DrugsFDA
ACCORD HEALTHCARE, INC. recalls Levothyroxine Sodium Tablets, USP, 50 mcg (0.05 mg), 1000 bottles, Rx Only, Manufactured for Accord Healthcare, Inc., Ra
Hazard: Subpotent
May 7, 2025DrugsFDA
ACCORD HEALTHCARE, INC. recalls Levothyroxine Sodium Tablets, USP, 25 mcg (0.025 mg), 1000 bottles, Rx Only, Manufactured for Accord Healthcare, Inc., R
Hazard: Subpotent
December 11, 2024DrugsFDA
ACCORD HEALTHCARE, INC. recalls Levothyroxine Sodium Tablets, USP, 75 mcg (0.075 mg), 1000-count bottle, Rx Only, Manufactured for: Accord Healthcare, I
Hazard: Subpotent drug
November 6, 2024DrugsFDA
ACCORD HEALTHCARE, INC. recalls Cinacalcet Tablets, 90 mg, Rx Only, a) 30 Tablets per bottle, NDC: 16729-442-10, b) 90 Tablets per bottle, NDC: 16729-44
Hazard: CGMP Deviations: the presence of a nitrosamine impurity, N-nitroso-cinacalcet, above the acceptable daily intake (ADI) limits.
November 6, 2024DrugsFDA
ACCORD HEALTHCARE, INC. recalls Cinacalcet Tablets, 60 mg, Rx Only, a) 30 Tablets per bottle, NDC: 16729-441-10, b) 90 Tablets per bottle, NDC: 16729-44
Hazard: CGMP Deviations: the presence of a nitrosamine impurity, N-nitroso-cinacalcet, above the acceptable daily intake (ADI) limits.
November 6, 2024DrugsFDA
ACCORD HEALTHCARE, INC. recalls Cinacalcet Tablets 30 mg, Rx Only, a) 30 Tablets per bottle, NDC: 16729-440-10, b) 90 Tablets per bottle, NDC: 16729-440
Hazard: CGMP Deviations: the presence of a nitrosamine impurity, N-nitroso-cinacalcet, above the acceptable daily intake (ADI) limits.
October 23, 2024DrugsFDA
ACCORD HEALTHCARE, INC. recalls Cisplatin Injection, 100mg/100mL (1mg/mL), For Intravenous Use, 100 mL Multiple Dose Vial, Rx Only, Manufactured for: Ac
Hazard: Failed Impurities/Degradation Specifications.
July 10, 2024DrugsFDA
Accord Healthcare, Inc. recalls Dodex Injectable (Cyanocobalamin Injection) USP, 1,000mcg/mL, 1mL multiple dose vial, Rx only, Manufactured for: Accord
Hazard: Subpotent drug: out of specification results
July 19, 2023DrugsFDA
Accord Healthcare, Inc. recalls Bivalirudin for Injection 250 mg, 10 Single-Dose Vials, Rx Only, Manufactured for: Accord Healthcare, Inc. Durham, NC 27
Hazard: Presence of Particulate Matter: Particulate matter identified as fiber.
July 19, 2023DrugsFDA
Accord Healthcare, Inc. recalls Atropine Sulfate Injection, USP 8 mg per 20 mL (0.4 mg per mL), 20 mL Multiple Dose Vials, Rx only, Manufactured for: A
Hazard: Presence of Particulate Matter: Particulate matter identified as fiber.
April 12, 2023DrugsFDA
Accord Healthcare, Inc. recalls Dodex Injectable Cyanocobalamin Injection, USP 1,000 mcg/mL, 25 x1 ML Multiple dose vials, For Intramuscular or Subcutan
Hazard: Sub-potent drug: assay test result below specifications at 9-month timepoint.
March 8, 2023DrugsFDA
Accord Healthcare, Inc. recalls rOPINIRole Tablets USP 5 mg* 100-count bottle, Rx Only, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703 Manu
Hazard: CGMP Deviations: recalling drug products following an FDA inspection.
March 8, 2023DrugsFDA
Accord Healthcare, Inc. recalls rOPINIRole Tablets USP 4 mg* 100-count bottle, Rx Only, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703 Manu
Hazard: CGMP Deviations: recalling drug products following an FDA inspection.
March 8, 2023DrugsFDA
Accord Healthcare, Inc. recalls rOPINIRole Tablets USP 3 mg*, 100-count bottle, Rx Only, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703 Man
Hazard: CGMP Deviations: recalling drug products following an FDA inspection.
March 8, 2023DrugsFDA
Accord Healthcare, Inc. recalls rOPINIRole Tablets USP 2 mg*, 100-count bottle, Rx Only, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703 Ma
Hazard: CGMP Deviations: recalling drug products following an FDA inspection.
March 8, 2023DrugsFDA
Accord Healthcare, Inc. recalls rOPINIRole Tablets USP 1 mg*, 100-count bottle, Rx Only, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703 Man
Hazard: CGMP Deviations: recalling drug products following an FDA inspection.
March 8, 2023DrugsFDA
Accord Healthcare, Inc. recalls rOPINIRole Tablets USP 0.5 mg*, 100-count bottle, Rx Only, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703 M
Hazard: CGMP Deviations: recalling drug products following an FDA inspection.
March 8, 2023DrugsFDA
Accord Healthcare, Inc. recalls rOPINIRole Tablets USP 0.25 mg*, 100-count bottle, Rx Only, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703
Hazard: CGMP Deviations: recalling drug products following an FDA inspection.
March 8, 2023DrugsFDA
Accord Healthcare, Inc. recalls Pravastatin Sodium Tablets USP, 80 mg, Rx Only, 90- count bottle, Manufactured for: Accord Healthcare, Inc., Durham, NC
Hazard: CGMP Deviations: recalling drug products following an FDA inspection.