The Recall Desk

Manufacturer

Accord Healthcare, Inc.

90 recalls in our database name Accord Healthcare, Inc. as the manufacturing or recalling firm.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

1–25 of 90

  • HighFDA (Drugs)·D-0006-2026·2025-10-15

    Levothyroxine Sodium Tablets Recalled for Subpotency Issue Nationwide

    Accord Healthcare is recalling 54,432 bottles of Levothyroxine Sodium Tablets 88 mcg due to subpotency—tablets contain less active ingredient than specified. Lot D2300045 was distributed nationwide; patients should verify their lot number and contact their pharmacy.

    Product
    LEVOTHYROXINE SODIUM — LEVOTHYROXINE SODIUM (LEVOTHYROXINE SODIUM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0518-2025·2025-07-23

    Levothyroxine Sodium Tablets Recalled for Subpotency Nationwide

    Accord Healthcare is recalling 82,159 bottles of Levothyroxine Sodium Tablets (25 mcg) nationwide because the active ingredient levels are below the approved specification.

    Product
    LEVOTHYROXINE SODIUM — LEVOTHYROXINE SODIUM (LEVOTHYROXINE SODIUM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0521-2025·2025-07-23

    Levothyroxine Sodium tablets recalled for subpotent assay across multiple lots

    Accord Healthcare is recalling Levothyroxine Sodium tablets due to assay results below approved specifications. The recalled product is a thyroid replacement medication distributed nationwide.

    Product
    LEVOTHYROXINE SODIUM — LEVOTHYROXINE SODIUM (LEVOTHYROXINE SODIUM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0523-2025·2025-07-23

    Levothyroxine Sodium 150 mcg Tablets Recalled for Subpotency

    Accord Healthcare is recalling 4,921 bottles of Levothyroxine Sodium 150 mcg tablets nationwide due to subpotency—the active ingredient assays below FDA-approved specifications. Patients should consult their prescriber.

    Product
    LEVOTHYROXINE SODIUM — LEVOTHYROXINE SODIUM (LEVOTHYROXINE SODIUM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0519-2025·2025-07-23

    Levothyroxine Sodium Tablets Recalled for Subpotent Drug Nationwide

    Accord Healthcare recalls Levothyroxine Sodium Tablets nationwide due to subpotent drug content. Affected lot #D2400679 may contain below-specification levels of active ingredient.

    Product
    LEVOTHYROXINE SODIUM — LEVOTHYROXINE SODIUM (LEVOTHYROXINE SODIUM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0524-2025·2025-07-23

    Levothyroxine Sodium 175 mcg Tablets Recalled for Subpotent Assay

    Accord Healthcare is recalling 2,344 bottles of Levothyroxine Sodium 175 mcg tablets (Lot #D2300042) nationwide due to subpotency—the drug assay tested below FDA-approved specification.

    Product
    LEVOTHYROXINE SODIUM — LEVOTHYROXINE SODIUM (LEVOTHYROXINE SODIUM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0522-2025·2025-07-23

    Levothyroxine Sodium Tablets Recalled Due to Below-Specification Potency

    Accord Healthcare is recalling Levothyroxine Sodium Tablets (112 mcg) due to subpotency; the drug's active ingredient levels fell below FDA specifications. Affected patients should consult their doctors.

    Product
    LEVOTHYROXINE SODIUM — LEVOTHYROXINE SODIUM (LEVOTHYROXINE SODIUM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0520-2025·2025-07-23

    Levothyroxine Sodium Tablets Recalled Due to Subpotent Drug Content

    Accord Healthcare is recalling Levothyroxine Sodium Tablets 50 mcg nationwide because tablets may contain less active ingredient than labeled. Affected lot #D2300087 should be returned or discarded.

    Product
    LEVOTHYROXINE SODIUM — LEVOTHYROXINE SODIUM (LEVOTHYROXINE SODIUM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0396-2025·2025-05-07

    FDA Recalls Accord Levothyroxine Sodium Tablets Nationwide for Subpotency

    Accord Healthcare recalls 4,885 bottles of Levothyroxine Sodium 88 mcg tablets nationwide due to subpotency. Tablets contain less active ingredient than labeled, potentially affecting medication efficacy.

    Product
    LEVOTHYROXINE SODIUM — LEVOTHYROXINE SODIUM (LEVOTHYROXINE SODIUM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0397-2025·2025-05-07

    Levothyroxine Sodium tablets recalled nationwide for subpotency

    Accord Healthcare is recalling 18,984 bottles of Levothyroxine Sodium 112 mcg tablets nationwide due to subpotency. The tablets contain less active ingredient than labeled, potentially reducing therapeutic effectiveness.

    Product
    LEVOTHYROXINE SODIUM — LEVOTHYROXINE SODIUM (LEVOTHYROXINE SODIUM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0395-2025·2025-05-07

    Levothyroxine Sodium Tablets Recalled Due to Subpotency Nationwide

    Accord Healthcare is recalling 4,872 bottles of Levothyroxine Sodium Tablets nationwide due to subpotency. The tablets contain less active ingredient than labeled.

    Product
    LEVOTHYROXINE SODIUM — LEVOTHYROXINE SODIUM (LEVOTHYROXINE SODIUM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0394-2025·2025-05-07

    Levothyroxine Sodium Tablets Recalled Nationwide for Subpotent Dosing

    Accord Healthcare is voluntarily recalling Levothyroxine Sodium 25 mcg tablets due to subpotency. The affected lot may contain less active ingredient than labeled, potentially impacting treatment effectiveness for patients taking this prescription thyroid medication.

    Product
    LEVOTHYROXINE SODIUM — LEVOTHYROXINE SODIUM (LEVOTHYROXINE SODIUM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0076-2025·2024-12-11

    Levothyroxine Sodium Tablets Recalled Due to Subpotency Nationwide

    Accord Healthcare is recalling Levothyroxine Sodium 75 mcg tablets (Lot D2300191, expiring 12/31/2025) distributed nationwide due to subpotency. Affected patients should contact their healthcare provider.

    Product
    LEVOTHYROXINE SODIUM — LEVOTHYROXINE SODIUM (LEVOTHYROXINE SODIUM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0032-2025·2024-11-06

    Cinacalcet 90 mg Tablets Recalled for Nitrosamine Impurity Above Safety Limits

    Accord Healthcare is recalling Cinacalcet 90 mg tablets nationwide due to nitrosamine impurity (N-nitroso-cinacalcet) at levels exceeding the FDA's acceptable daily intake limit. The issue stems from manufacturing process deviations.

    Product
    CINACALCET — CINACALCET (CINACALCET)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0030-2025·2024-11-06

    Accord Healthcare Recalls Cinacalcet Tablets Due to Nitrosamine Contamination

    Accord Healthcare is recalling Cinacalcet 30mg tablets nationwide due to a nitrosamine impurity (N-nitroso-cinacalcet) exceeding acceptable daily intake limits. Patients should consult their healthcare provider to confirm if their medication is affected.

    Product
    CINACALCET — CINACALCET (CINACALCET)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0031-2025·2024-11-06

    Cinacalcet Tablets Recalled Due to Nitrosamine Impurity

    Accord Healthcare recalls Cinacalcet 60mg tablets nationwide because N-nitroso-cinacalcet impurity was detected above acceptable daily intake limits. The contamination resulted from manufacturing process deviations.

    Product
    CINACALCET — CINACALCET (CINACALCET)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0010-2025·2024-10-23

    Cisplatin Injection Vials Recalled for Failed Impurity and Degradation Standards

    Accord Healthcare is recalling 11,214 vials of Cisplatin Injection due to failed impurity and degradation specifications. The recalled lot was distributed nationwide in the United States and Puerto Rico.

    Product
    CISPLATIN — CISPLATIN (CISPLATIN)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0580-2024·2024-07-10

    Dodex Injectable Cyanocobalamin Recalled Due to Subpotent Drug Defect

    Accord Healthcare is recalling Dodex Injectable (Cyanocobalamin) due to subpotency; affected batches contain less active ingredient than labeled. Patients using affected lots should contact their healthcare provider.

    Product
    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
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0918-2023·2023-07-19

    FDA Recalls Bivalirudin Injectable Drug Due to Particulate Matter

    Accord Healthcare is recalling Bivalirudin for Injection lot M2212070 due to the presence of fiber particles. Bivalirudin is an injectable blood thinner used in cardiac procedures.

    Product
    BIVALIRUDIN — BIVALIRUDIN (BIVALIRUDIN)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0528-2023·2023-04-12

    Cyanocobalamin injection vials recalled for failing potency tests

    Accord Healthcare recalled 4,574 cartons of Cyanocobalamin injection (Lot R2200394) nationwide after testing showed the drug was sub-potent and failed to meet strength specifications.

    Product
    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., Dur
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0424-2023·2023-03-08

    Pravastatin Sodium 80 mg tablets recalled for manufacturing deviations

    Accord Healthcare is recalling Pravastatin Sodium 80 mg tablets due to manufacturing process deviations discovered during an FDA inspection. The recall affects approximately 1,970 bottles distributed in the United States, Puerto Rico, and Canada.

    Product
    PRAVASTATIN SODIUM — PRAVASTATIN SODIUM (PRAVASTATIN SODIUM)
    Category
    Drug
    Distribution
    0 states
  • HighFDA (Drugs)·D-0379-2023·2023-03-08

    FDA recalls Buspirone Hydrochloride tablets for manufacturing practice deviations

    Accord Healthcare is recalling approximately 25,812 bottles of Buspirone Hydrochloride 30mg tablets due to manufacturing practice deviations discovered during an FDA inspection.

    Product
    BUSPIRONE HYDROCHLORIDE — BUSPIRONE HYDROCHLORIDE (BUSPIRONE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    0 states
  • HighFDA (Drugs)·D-0384-2023·2023-03-08

    Dofetilide antiarrhythmic prescription drug recalled for manufacturing deviations

    Accord Healthcare is recalling 113,571 bottles of dofetilide capsules distributed in the US, Puerto Rico, and Canada due to Current Good Manufacturing Practice (CGMP) deviations found during FDA inspection. No illnesses have been reported.

    Product
    DOFETILIDE — DOFETILIDE (DOFETILIDE)
    Category
    Drug
    Distribution
    0 states
  • HighFDA (Drugs)·D-0403-2023·2023-03-08

    Phenylephrine Hydrochloride Injection recalled due to manufacturing practice deviations

    Accord Healthcare is recalling Phenylephrine Hydrochloride Injection vials due to manufacturing practice deviations discovered during an FDA inspection. Affected batches were distributed in the United States, Puerto Rico, and Canada.

    Product
    Phenylephrine Hydrochloride Injection, USP 100 mg/10 mL (10 mg/mL), Rx Only, 10 mL Vial, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703 Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213, INDIA; NDC 16729-466-03, UPC 3 16729 46603 5
    Category
    Drug
    Distribution
    0 states