A batch of Ramipril capsules has been recalled after some packs were found to contain a different blood pressure drug. Health authorities say the risk to patients remains low but advise checking packaging immediately.
A recall has been issued in the United Kingdom for a specific batch of Ramipril 5 mg capsules after a packaging mix-up raised concerns about medication safety. The Medicines and Healthcare products Regulatory Agency (MHRA) said blister strips of another blood pressure drug, Amlodipine, may have been mistakenly placed inside cartons labeled as Ramipril.
The precautionary recall applies to batch number GR164099, manufactured by Crescent Pharma Limited. According to the MHRA, pharmacies and healthcare professionals have been asked to return any remaining stock while patients are advised to verify the contents of their medication packaging.
Packaging Mix-up Identified After Pharmacy Complaint
The issue first came to light when a pharmacy reported that a patient had opened a sealed carton labeled as Ramipril and discovered blister strips containing Amlodipine tablets. According to the MHRA, both medications are produced by Crescent Pharma at the same manufacturing facility.
Investigators believe the error occurred during the secondary packaging stage of production. This stage involves placing pre-packaged blister strips into the outer cartons that carry the drug’s labeling and dosage information.
Ramipril capsules and Amlodipine tablets are visually distinct. Ramipril 5 mg capsules are described as light grey and green gelatin capsules marked with an “R” on the cap and “5” on the body. Amlodipine tablets, by contrast, are white to off-white round tablets with a “5” debossed on one side.
Health officials are urging patients prescribed Ramipril to check their medication for batch number GR164099, which appears on the outer carton along with the expiry date. According to the MHRA, anyone who finds blister strips labeled “Amlodipine 5 mg tablets” inside a Ramipril carton should return the pack to their pharmacy for advice and replacement medication.
If the blister strips inside the carton are correctly labeled as Ramipril capsules, patients do not need to take further action.
Health Officials Say the Overall Risk to Patients Is Low
The MHRA has emphasized that the potential health risk from the packaging error remains limited, largely because both medications are prescribed to treat high blood pressure. Shareen Doak, Deputy Director of Benefit-Risk Evaluation at the MHRA, said patients should simply verify that the name printed on the blister strips matches the label on the outer packaging. According to the regulator, the most likely side effect if someone unintentionally takes Amlodipine instead of Ramipril would be dizziness caused by a drop in blood pressure.
Doak also reassured patients who may already have taken the tablets in error. According to her statement released through the MHRA, there is a very low risk to health in such cases. Still, patients who experience symptoms or side effects are advised to seek medical attention. Health authorities recommend bringing the medication leaflet and any remaining tablets when visiting a pharmacy or GP surgery to help professionals assess the situation.
The MHRA has also encouraged patients and healthcare providers to report any suspected adverse reactions through its Yellow Card reporting scheme. This monitoring system helps regulators track safety issues with medicines once they are in circulation.
For now, the recall remains limited to the single affected batch. Pharmacies and healthcare professionals across the UK have been instructed to remove and return any remaining packs from that batch to their suppliers while investigations into the packaging error continue.
