The Recall Desk

Manufacturer

Accord Healthcare, Inc.

91 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 91

  • ModerateFDA (Drugs)·D-0656-2026·2026-07-08

    Levothyroxine Sodium 300 mcg Tablets Recalled for Subpotency

    Accord Healthcare is recalling Levothyroxine Sodium Tablets 300 mcg (90-tablet bottles) nationwide due to subpotency. The affected lot is D2401522 with expiration date 06/2026.

    Product
    LEVOTHYROXINE SODIUM — LEVOTHYROXINE SODIUM (LEVOTHYROXINE SODIUM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • Severity pendingFDA (Drugs)·D-0006-2026·2025-10-15

    LEVOTHYROXINE SODIUM (LEVOTHYROXINE SODIUM)

    Pending LLM rewrite. Source: FDA_DRUG D-0006-2026.

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

    LEVOTHYROXINE SODIUM (LEVOTHYROXINE SODIUM)

    Pending LLM rewrite. Source: FDA_DRUG D-0524-2025.

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

    LEVOTHYROXINE SODIUM (LEVOTHYROXINE SODIUM)

    Pending LLM rewrite. Source: FDA_DRUG D-0519-2025.

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

    LEVOTHYROXINE SODIUM (LEVOTHYROXINE SODIUM)

    Pending LLM rewrite. Source: FDA_DRUG D-0518-2025.

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

    LEVOTHYROXINE SODIUM (LEVOTHYROXINE SODIUM)

    Pending LLM rewrite. Source: FDA_DRUG D-0523-2025.

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

    LEVOTHYROXINE SODIUM (LEVOTHYROXINE SODIUM)

    Pending LLM rewrite. Source: FDA_DRUG D-0521-2025.

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

    LEVOTHYROXINE SODIUM (LEVOTHYROXINE SODIUM)

    Pending LLM rewrite. Source: FDA_DRUG D-0522-2025.

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

    LEVOTHYROXINE SODIUM (LEVOTHYROXINE SODIUM)

    Pending LLM rewrite. Source: FDA_DRUG D-0520-2025.

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

    Levothyroxine Sodium Tablets 88 mcg Recall for Subpotency

    Accord Healthcare is recalling Levothyroxine Sodium Tablets 88 mcg (Lot D2300044, expiring 12/2025) nationwide because the tablets are subpotent—below the required strength. Patients on this medication should contact their pharmacy or prescriber.

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

    Levothyroxine Sodium Tablets Nationwide Recall Due to Subpotency

    Accord Healthcare is recalling approximately 18,984 bottles of Levothyroxine Sodium Tablets, 112 mcg, nationwide because the tablets are subpotent. Patients taking this medication should contact their pharmacy or healthcare provider immediately.

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

    Levothyroxine Sodium Tablets 50 mcg Recalled for Subpotency

    Accord Healthcare is recalling 4,872 bottles of Levothyroxine Sodium Tablets (50 mcg) nationwide because the tablets are subpotent and may not provide the intended therapeutic effect.

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

    Levothyroxine Sodium Tablets Recalled for Subpotency by Accord Healthcare

    Accord Healthcare is recalling 4,888 bottles of Levothyroxine Sodium Tablets (25 mcg) nationwide due to subpotency. The affected lot is D2300323 with expiration date 01/2026.

    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-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-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-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-0402-2023·2023-03-08

    Phenylephrine Hydrochloride Injection Recalled for Manufacturing Practice Deviations

    Accord Healthcare is recalling 5,090 vials of Phenylephrine Hydrochloride Injection due to manufacturing deviations found during an FDA inspection. Affected batches include R2101570, R2101574, and R2101576, distributed in the United States, Puerto Rico, and Canada.

    Product
    Phenylephrine Hydrochloride Injection, USP, 50 mg/5mL (10 mg/mL), Rx Only, 5 mL Vial, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703 Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213, INDIA; Vial NDC 16729-465-31, UPC 3 16729 46531 1; Carton
    Category
    Drug
    Distribution
    0 states
  • HighFDA (Drugs)·D-0399-2023·2023-03-08

    Glycopyrrolate Injection Recalled Due to Manufacturing Quality Deviations

    Accord Healthcare is recalling Glycopyrrolate Injection (4 mg/20 mL) from two batches due to CGMP deviations identified during FDA inspection. No illnesses have been reported.

    Product
    GLYCOPYRROLATE — GLYCOPYRROLATE (GLYCOPYRROLATE)
    Category
    Drug
    Distribution
    0 states