Accord Healthcare recalls

14 official recalls and safety alerts involving Accord Healthcare since 2023-01, from FDA · Drug. Newest first. Check the official notice for exact models and batch codes.

This list only includes recalls Recall Atlas has collected since 2021-10. A product not listed here may still be affected; check with Accord Healthcare or the relevant agency.

1. 2026-09-02
2. US
   Drugs & medicalClass II

   ACCORD HEALTHCARE, INC. recalls Levothyroxine Sodium Tablets, USP, 200 mcg (0.2 mg), packaged in a) 90-count bottles (NDC 16729-457-15) and b) 1000-count bottles (NDC…

   Subpotent Drug

   FDA · DrugACCORD HEALTHCARE, INC.Nationwide within the United StatesOfficial notice →
3. 2026-07-08
4. US
   Drugs & medicalClass II

   ACCORD HEALTHCARE, INC. recalls Levothyroxine Sodium Tablets, USP, 300 mcg (0.3mg), 90 Tablets bottles, Rx only, Manufactured for: Accord Healthcare, Inc., Raleigh, NC…

   Subpotent Drug

   FDA · DrugACCORD HEALTHCARE, INC.US Nationwide.Official notice →
5. 2025-10-15
6. US
   Drugs & medicalClass II

   ACCORD HEALTHCARE, INC. recalls Levothyroxine Sodium Tablets, USP, 88 mcg (0.088 mg), 90 Tablets per bottle, Rx Only, Manufactured for Accord Healthcare, Inc., Raleigh,…

   Subpotent: During long term stability testing of Levothyroxine Sodium Tablets USP for 88 mcg, the assay content was observed below the approved specification range.

   FDA · DrugACCORD HEALTHCARE, INC.Nationwide in the USOfficial notice →
7. 2025-07-23
8. US
   Drugs & medicalClass II

   ACCORD HEALTHCARE, INC. recalls Levothyroxine Sodium Tablets, USP, 150 mcg (0.15 mg), 1000-count bottle, Rx Only, Manufactured for: Accord Healthcare, Inc., Raleigh, NC…

   Subpotent Drug: Assay below the approved specification

   FDA · DrugACCORD HEALTHCARE, INC.Nationwide in the USAOfficial notice →
9. 2025-05-07
10. US
    Drugs & medicalClass II

    ACCORD HEALTHCARE, INC. recalls Levothyroxine Sodium Tablets, USP, 88 mcg (0.088 mg), 1000 bottles, Rx Only, Manufactured for Accord Healthcare, Inc., Raleigh, NC 27617,…

    Subpotent

    FDA · DrugACCORD HEALTHCARE, INC.Nationwide US.Official notice →
11. 2024-12-11
12. US
    Drugs & medicalClass II

    ACCORD HEALTHCARE, INC. recalls Levothyroxine Sodium Tablets, USP, 75 mcg (0.075 mg), 1000-count bottle, Rx Only, Manufactured for: Accord Healthcare, Inc., Durham, NC…

    Subpotent drug

    FDA · DrugACCORD HEALTHCARE, INC.USA NationwideOfficial notice →
13. 2024-11-06
14. US
    Drugs & medicalClass II

    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: 16729-442-15,…

    CGMP Deviations: the presence of a nitrosamine impurity, N-nitroso-cinacalcet, above the acceptable daily intake (ADI) limits.

    FDA · DrugACCORD HEALTHCARE, INC.Nationwide in the USA and PROfficial notice →
15. 2024-10-23
16. US
    Drugs & medicalClass II

    ACCORD HEALTHCARE, INC. recalls Cisplatin Injection, 100mg/100mL (1mg/mL), For Intravenous Use, 100 mL Multiple Dose Vial, Rx Only, Manufactured for: Accord Healthcare…

    Failed Impurities/Degradation Specifications.

    FDA · DrugACCORD HEALTHCARE, INC.Nationwide within the United States and PROfficial notice →
17. 2024-07-10
18. US
    Drugs & medicalClass III

    Accord Healthcare, Inc. recalls Dodex Injectable (Cyanocobalamin Injection) USP, 1,000mcg/mL, 1mL multiple dose vial, Rx only, Manufactured for: Accord Healthcare, Inc.,…

    Subpotent drug: out of specification results

    FDA · DrugAccord Healthcare, Inc.USA NationwideOfficial notice →
19. 2023-07-19
20. US
    Drugs & medicalClass II

    Accord Healthcare, Inc. recalls Bivalirudin for Injection 250 mg, 10 Single-Dose Vials, Rx Only, Manufactured for: Accord Healthcare, Inc. Durham, NC 27703 Manufactured…

    Presence of Particulate Matter: Particulate matter identified as fiber.

    FDA · DrugAccord Healthcare, Inc.Nationwide within the United StatesOfficial notice →
21. 2023-04-12
22. US
    Drugs & medicalClass III

    Accord Healthcare, Inc. recalls Dodex Injectable Cyanocobalamin Injection, USP 1,000 mcg/mL, 25 x1 ML Multiple dose vials, For Intramuscular or Subcutaneous Use Only, Rx…

    Sub-potent drug: assay test result below specifications at 9-month timepoint.

    FDA · DrugAccord Healthcare, Inc.Nationwide in the USA.Official notice →
23. 2023-03-08
24. US
    Drugs & medicalClass II

    Accord Healthcare, Inc. recalls Dofetilide Capsules 250 mcg (0.25 mg) 60-count bottle, Rx only, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703. Manufactured…

    CGMP Deviations: recalling drug products following an FDA inspection.

    FDA · DrugAccord Healthcare, Inc.United States including Puerto Rico and CanadaOfficial notice →
25. 2023-02-01
26. US
    Drugs & medicalClass II

    Accord Healthcare, Inc. recalls Allopurinol Tablets USP, 100 mg, 100-count bottle, Rx Only, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703, Manufactured by:…

    Presence of Foreign Substance: Presence of a small piece of green plastic embedded in the crack towards the edge of the tablet.

    FDA · DrugAccord Healthcare, Inc.Nationwide in the USAOfficial notice →
27. 2023-01-25
28. US
    Drugs & medicalClass I

    Accord Healthcare, Inc. recalls Daptomycin for Injection 350 mg/vial 1 Single-dose vial, Rx only, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703…

    Labeling mixup: cartons labeled as Daptomycin 350 mg/vial were found to contain vials of Daptomycin 500 mg per vial

    FDA · DrugAccord Healthcare, Inc.Nationwide within the United StatesOfficial notice →