Precautionary recall issued for blood pressure capsules after packaging error raises dosing concerns

A batch of a commonly prescribed blood pressure medication is being recalled across the UK after a manufacturing error raised the risk of patients unknowingly taking a lower dose than prescribed.

The Medicines and Healthcare products Regulatory Agency (MHRA) has ordered an immediate halt to the supply of one batch of Ramipril 10mg capsules, after it emerged that some packs may contain blister strips of the lower 5mg strength instead.

Pharmacies and healthcare providers have been instructed to stop dispensing the affected stock and return it to suppliers without delay.

Packaging error discovered after patient complaint

The recall affects a batch produced by Crescent Pharma Limited, following a patient complaint which revealed a critical mismatch inside a sealed medication pack.

According to the MHRA, a carton labelled as Ramipril 10mg capsules was found to contain one blister strip of Ramipril 5mg capsules. Both strengths had been manufactured at the same site, with the error believed to have occurred during the secondary packaging stage.

The issue is isolated to batch number GR174091, with patients now being urged to check their medication carefully.

What patients are being told to do

Dr Alison Cave, Chief Safety Officer at the MHRA, issued clear guidance for anyone currently taking the medication.

“If you take Ramipril 10mg, check the packaging for batch number GR174091. The batch number and expiry date information can be found on the outer carton. If you have received this batch, check that the medication name on the carton matches the blister strips inside.

“If the 10 mg carton of Ramipril contains blister strips that are labelled as Ramipril 5mg capsules, contact your dispensing pharmacy. If the carton contains blister strips that are correctly labelled as Ramipril 10mg capsules, you do not need to take further action.”

Patients who discover a mismatch are advised not to continue using the medication until they have spoken to a pharmacist.

Health risk described as ‘very low’

Despite the error, regulators have stressed that the immediate health risk remains low.

Ramipril is used to treat high blood pressure, heart failure and certain kidney conditions, and both 5mg and 10mg strengths are routinely prescribed depending on clinical need.

The MHRA said the risk of harm from taking a lower dose for a short period is minimal, with any potential impact expected to develop gradually rather than posing an immediate or life-threatening danger.

Patients who may have taken the lower dose in error are being reassured but advised to remain vigilant.

“If you’ve already taken Ramipril 5mg, please be reassured that there is a very low risk to your health,” the agency said.

Advice for anyone experiencing symptoms

Anyone who believes they may have been affected and is experiencing adverse symptoms is urged to seek medical advice.

Patients are advised to take their medication packaging, including the leaflet and any remaining capsules, to their pharmacist or GP for review.

Any suspected side effects should also be reported through the MHRA’s Yellow Card scheme, which is used to monitor the safety of medicines across the UK.

Wider action across pharmacies and healthcare providers

The MHRA has formally instructed pharmacies and healthcare professionals to immediately stop supplying the affected batch and return all remaining stock to suppliers.

The regulator said the recall is being carried out as a precautionary measure while further investigation continues.

The MHRA oversees the safety and effectiveness of medicines and medical devices in the UK, with decisions based on evidence to ensure that benefits continue to outweigh any risks.

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At a glance

• One batch of Ramipril 10mg capsules is being recalled across the UK

• Error means some packs may contain 5mg capsules instead of 10mg

• Affected batch number: GR174091

• Issue discovered after a patient found incorrect blister strips in sealed pack

• Error likely occurred during secondary packaging at manufacturing site

• MHRA has ordered pharmacies to stop supplying and return stock immediately

• Patients urged to check packaging and blister strips match

• Risk to health described as “very low” if lower dose taken temporarily

• Anyone experiencing side effects should seek medical advice

• Suspected reactions should be reported via the MHRA Yellow Card scheme