DrugSep 2, 2026
Levothyroxine Sodium Tablets, USP, 200 mcg (0.2 mg) recall — FDA D-0785-2026
Subpotent Drug
Class IIFDA: OngoingACCORD HEALTHCARE, Inc.
Recall history in this database
Classification mix: Class II: 86, Class III: 2, Class I: 2.
DrugSep 2, 2026
Levothyroxine Sodium Tablets, USP, 137 mcg (0.137 mg) recall — FDA D-0782-2026
Subpotent Drug
Class IIFDA: OngoingACCORD HEALTHCARE, Inc.
DrugSep 2, 2026
Levothyroxine Sodium Tablets, USP, 175 mcg (0.175 mg) recall — FDA D-0784-2026
Subpotent Drug
Class IIFDA: OngoingACCORD HEALTHCARE, Inc.
DrugSep 2, 2026
Levothyroxine Sodium Tablets, USP, 100 mcg (0.1 mg) recall — FDA D-0779-2026
Subpotent Drug
Class IIFDA: OngoingACCORD HEALTHCARE, Inc.
DrugOct 15, 2025
Levothyroxine Sodium Tablets, USP, 88 mcg (0.088 mg), 90 Tablets per bottle recall — FDA D-0006-2026
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 IIFDA: OngoingACCORD HEALTHCARE, INC.
DrugJul 23, 2025
Levothyroxine Sodium Tablets, USP, 150 mcg (0.15 mg), 1000-count bottle recall — FDA D-0523-2025
Subpotent Drug: Assay below the approved specification
Class IIFDA: OngoingACCORD HEALTHCARE, INC.
DrugJul 23, 2025
Levothyroxine Sodium Tablets, USP, 25 mcg (0.025 mg), 90-count bottle recall — FDA D-0518-2025
Subpotent Drug: Assay below the approved specification
Class IIFDA: OngoingACCORD HEALTHCARE, INC.
DrugJul 23, 2025
Levothyroxine Sodium Tablets, USP, 50 mcg (0.05 mg), 90-count bottle recall — FDA D-0520-2025
Subpotent Drug: Assay below the approved specification
Class IIFDA: OngoingACCORD HEALTHCARE, INC.
DrugJul 23, 2025
Levothyroxine Sodium Tablets, USP, 175 mcg (0.175 mg), 1000-count bottle recall — FDA D-0524-2025
Subpotent Drug: Assay below the approved specification
Class IIFDA: OngoingACCORD HEALTHCARE, INC.
DrugJul 23, 2025
Levothyroxine Sodium Tablets, USP, 112 mcg (0.112 mg), 1000-count bottle recall — FDA D-0522-2025
Subpotent Drug: Assay below the approved specification
Class IIFDA: OngoingACCORD HEALTHCARE, INC.
DrugJul 23, 2025
Levothyroxine Sodium Tablets, USP, 25 mcg (0.025 mg), 1000-count bottle recall — FDA D-0519-2025
Subpotent Drug: Assay below the approved specification
Class IIFDA: OngoingACCORD HEALTHCARE, INC.
DrugJul 23, 2025
Levothyroxine Sodium Tablets, USP, 100 mcg (0.1 mg), 1000-count bottle recall — FDA D-0521-2025
Subpotent Drug: Assay below the approved specification
Class IIFDA: OngoingACCORD HEALTHCARE, INC.
DrugNov 6, 2024
Cinacalcet Tablets, 90 mg recall — FDA D-0032-2025
CGMP Deviations: the presence of a nitrosamine impurity, N-nitroso-cinacalcet, above the acceptable daily intake (ADI) limits.
Class IIFDA: OngoingACCORD HEALTHCARE, INC.
DrugNov 6, 2024
Cinacalcet Tablets, 60 mg recall — FDA D-0031-2025
CGMP Deviations: the presence of a nitrosamine impurity, N-nitroso-cinacalcet, above the acceptable daily intake (ADI) limits.
Class IIFDA: OngoingACCORD HEALTHCARE, INC.
DrugNov 6, 2024
Cinacalcet Tablets 30 mg recall — FDA D-0030-2025
CGMP Deviations: the presence of a nitrosamine impurity, N-nitroso-cinacalcet, above the acceptable daily intake (ADI) limits.
Class IIFDA: OngoingACCORD HEALTHCARE, INC.
DrugOct 23, 2024
Cisplatin Injection, 100mg/100mL (1mg/mL), For Intravenous Use, 100 mL Multiple Dose Vial recall — FDA D-0010-2025
Failed Impurities/Degradation Specifications.
Class IIFDA: TerminatedACCORD HEALTHCARE, INC.
DrugJul 19, 2023
Bivalirudin for Injection 250 mg, 10 Single-Dose Vials recall — FDA D-0918-2023
Presence of Particulate Matter: Particulate matter identified as fiber.
Class IIFDA: TerminatedAccord Healthcare, Inc.
DrugJul 19, 2023
Atropine Sulfate Injection, USP 8 mg per 20 mL (0.4 mg per mL), 20 mL Multiple Dose Vials recall — FDA D-0917-2023
Presence of Particulate Matter: Particulate matter identified as fiber.
Class IIFDA: TerminatedAccord Healthcare, Inc.
DrugApr 12, 2023
Accord Healthcare Dodex Injectable Cyanocobalamin Injection, USP 1,000 mcg/mL, 25 x1 ML recall — FDA D-0528-2023
Sub-potent drug: assay test result below specifications at 9-month timepoint.
Class IIIFDA: TerminatedAccord Healthcare, Inc.
DrugMar 8, 2023
Dofetilide Capsules 250 mcg (0.25 mg) 60-count bottle recall — FDA D-0384-2023
CGMP Deviations: recalling drug products following an FDA inspection.
Class IIFDA: TerminatedAccord Healthcare, Inc.
DrugMar 8, 2023
Atorvastatin Calcium Tablets USP 80 mg* recall — FDA D-0374-2023
CGMP Deviations: recalling drug products following an FDA inspection.
Class IIFDA: TerminatedAccord Healthcare, Inc.
DrugMar 8, 2023
BusPIRone Hydrochloride Tablets USP 30 mg, 60-count bottle recall — FDA D-0379-2023
CGMP Deviations: recalling drug products following an FDA inspection.
Class IIFDA: TerminatedAccord Healthcare, Inc.
DrugMar 8, 2023
Montelukast Sodium Tablets, USP, 10 mg* recall — FDA D-0400-2023
CGMP Deviations: recalling drug products following an FDA inspection.
Class IIFDA: TerminatedAccord Healthcare, Inc.
DrugMar 8, 2023
Atorvastatin Calcium Tablets USP 40 mg* recall — FDA D-0373-2023
CGMP Deviations: recalling drug products following an FDA inspection.
Class IIFDA: TerminatedAccord Healthcare, Inc.
Understanding this recall history
This page summarizes recall records in which the official source identifies Accord Healthcare, Inc. as the recalling firm or manufacturer. The number of records should not be treated as a safety rating or a measure of company size, because recall counts depend on product mix, reporting periods and how government records are organized.
Compare the dates, categories and classifications together rather than relying on the total alone. Open an individual record for the recalled product, reason, distribution details and current instructions available from the source.