Somerset Therapeutics recalls

4 official recalls and safety alerts involving Somerset Therapeutics since 2024-05, 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 Somerset Therapeutics or the relevant agency.

  1. 2026-03-25
  2. US
    Drugs & medicalClass II

    SOMERSET THERAPEUTICS LLC recalls Dexamethasone Sodium Phosphate Injection, USP, 100 mg/ 10 mL, (10 mg/mL), 10x10 mL Multiple Dose Vials, Rx only, Manufactured for:…

    Failed Impurities/Degradation Specifications - OOS impurities result observed during long term stability testing at product expiry (24 months) were above specs for these impurities: Dexamethasone Sodium Phosphate EP…

    FDA · DrugSOMERSET THERAPEUTICS LLCNationwide in the USAOfficial notice →
  3. 2025-12-24
  4. US
    Drugs & medicalClass III

    SOMERSET THERAPEUTICS LLC recalls Cisatracurium Besylate Injection USP, 20 mg/10 mL*,(2 mg/mL), 10 x 10 mL Multiple-dose Vials per carton, Rx Only, Manufactured for:…

    Subpotent product:out of specification assay results observed during long term stability testing.

    FDA · DrugSOMERSET THERAPEUTICS LLCNationwide in the USAOfficial notice →
  5. 2025-01-08
  6. US
    Drugs & medicalClass III

    SOMERSET THERAPEUTICS LLC recalls Atropine Sulfate Ophthalmic Solution, USP 1%, 5 mL bottles, Rx only, Manufactured for: Somerset Therapeutics, LLC. Somerset, NJ 08873,…

    Failed Impurities/Degradation Specifications

    FDA · DrugSOMERSET THERAPEUTICS LLCNationwide within the United StatesOfficial notice →
  7. 2024-05-29
  8. US
    Drugs & medicalClass II

    SOMERSET THERAPEUTICS LLC recalls Haloperidol decanoate Injection 50mg/mL, packaged in a) 1 mL Single-Dose Vials (NDC 70069-381-01) and b) 10 1mL Single-Dose Vials (NDC…

    Presence of Foreign Substance: This oil based product may contain trace amounts of water for injection (WFI).

    FDA · DrugSOMERSET THERAPEUTICS LLCNationwide within the United StatesOfficial notice →