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UK Orders Class 2 Recall of Ramipril Batch After Amlodipine Found in Packs

Regulators order pharmacies to quarantine stock and trace patients, citing low overall risk.

Overview

  • MHRA’s Class 2 recall targets ramipril 5 mg batch GR164099 from Crescent Pharma, first distributed on June 6, 2025.
  • The mix-up appears to have occurred during secondary packaging at a site that manufactures both medicines.
  • Pharmacies must stop supplying the batch, quarantine and return stock, and identify and contact patients where traceability allows, including those dispensed between June 6, 2025 and March 6, 2026.
  • Patients are advised to check that carton and blister labels match and to return packs if blister strips read Amlodipine 5 mg, seeking medical advice if unwell.
  • MHRA says overall risk is low because both drugs treat hypertension, though unintended substitution could lower blood pressure and cause dizziness, with adverse events to be reported via the Yellow Card scheme.