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Medicines recallMHRA

Ramipril 5mg capsules recalled over a quality concern

Medicine quality concernHigh riskClass 2

Crescent Pharma Limited is recalling one batch of Ramipril 5 mg Capsules as a precautionary measure due to a potential error at the manufacturing site.

Check your product

Only products that match these details are covered. Have your pack in front of you.

3 identifiers listed for this notice.

  • Ramipril 5mg capsules 28

    Batch codePrinted on the pack, often next to the date mark. It may start with L or LOT.
    • GR164099
    ExpiryOn the carton, blister or label.
    • 10/2026
    First distributedOn the product, its label or its packaging.
    • 06 June 2025

What to do now

The MHRA has issued a notice about Ramipril 5mg capsules.

  1. Keep taking your medicine unless a healthcare professional tells you otherwise.
  2. Check the batch number and expiry date on your pack against the list on this page.
  3. If it matches, your pharmacist can swap it or arrange an alternative.
  4. Report suspected side effects to the MHRA Yellow Card scheme.

Why it matters. The MHRA classifies medicines recalls from Class 1 (most serious) to Class 4 (caution in use). The notice below sets out the details.

Symptoms and when to get help

Look out for

  • a side effect you have not had before
  • your condition not being controlled as well as usual

Get help urgently

  • signs of a severe allergic reaction, such as swelling of the face or throat or difficulty breathing — call 999
  • if you feel unwell and are worried, speak to a pharmacist, your GP or NHS 111

This is general information based on NHS public guidance, not medical advice. In an emergency call 999. For urgent advice use NHS 111 (NHS 24 on 111 in Scotland) or, in Northern Ireland, your GP or out-of-hours service.

Replacements and prescriptions

If your pack is affected, your pharmacy can usually exchange it for an unaffected batch or another suitable product. Prescription medicines are replaced through your pharmacy or prescriber; you do not need to buy a new supply yourself.

Many recalls are made at pharmacy or wholesaler level and do not require patients to act. The notice says which level applies.

From the official notice

Published by the Medicines and Healthcare products Regulatory Agency (EL(26)A/11). Quoted as issued.

Summary

Crescent Pharma Limited is recalling one batch of Ramipril 5 mg Capsules as a precautionary measure due to a potential error at the manufacturing site.

The risk

DMRC reference number DMRC- 38717889 Marketing Authorisation Holder

Advice for healthcare professionals

Stop supplying the impacted batch of Ramipril 5 mg Capsules immediately. Quarantine all remaining stock and return it to your supplier using your approved process.

If batch/product traceability information is available, pharmacy professionals and other healthcare professionals involved in dispensing medicinal products should identify and immediately contact all patients who have been dispensed the impacted product and ask them to confirm if they have remaining stock within their possession for return.

If batch/product traceability information is not available, pharmacists should identify all patients dispensed this product between 06 June 2025 and 06 March 2026. Where appropriate and feasible, contact all patients who have been dispensed the impacted product with priority given to those who have been dispensed the product most recently and within the last 28 days. The majority of this was distributed in 2025 and therefore it is expected that many of these packs will have been dispensed to patients and consumed.

If any patients are identified with this product, pharmacy professionals and other healthcare professionals involved in dispensing should also contact the patients’ GP, or healthcare professional responsible for the care of the patient, to discuss treatment review and if a new prescription is required for ongoing resupply.

Ramipril and amlodipine are both standard anti-hypertensives used in the treatment of hypertension and heart failure. Healthcare professionals should be advised to inform patients who may have taken the incorrect medication that they may experience dizziness symptoms related to blood pressure lowering secondary to taking a calcium channel blocker that they are new to. Additionally, as some patients may require monitoring, other clinicians and healthcare professionals may need to be involved. Healthcare professionals should be aware that only the batch stated in this notification is impacted.

Some cartons of Ramipril 5 mg Capsules, manufactured by Crescent Pharma Limited, may contain blister strips of Amlodipine 5 mg Tablets.

All packs of Ramipril 5 mg Capsule, Batch Number GR164099 are being recalled as a precautionary measure.

If you were prescribed Ramipril 5 mg Capsules and have received the impacted product batch (Batch Number GR164099) please check that the carton contains the correct medication. The batch number and expiry date information can be found on outer carton.

If the carton contains blister strips that are labelled and contain Amlodipine 5 mg tablets, contact your dispensing pharmacy in the first instance. If the carton contains blister strips that are labelled and contain Ramipril 5 mg Capsules, you do not need to take further action.

If you are unsure or have any questions, please seek advice from your pharmacy or other healthcare professionals responsible for your care.

If you have an impacted pack or previously received this batch, (where known) and you believe you have taken the Amlodipine 5 mg Tablets that were included in error and are currently experiencing any side effects, then please seek immediate medical advice.

Please take the leaflet that came with your medicine and any remaining tablets with you to your pharmacy or GP practice.

Advice for patients

Some cartons of Ramipril 5 mg Capsules, manufactured by Crescent Pharma Limited, may contain blister strips of Amlodipine 5 mg Tablets.

All packs of Ramipril 5 mg Capsule, Batch Number GR164099 are being recalled as a precautionary measure.

If you were prescribed Ramipril 5 mg Capsules and have received the impacted product batch (Batch Number GR164099) please check that the carton contains the correct medication. The batch number and expiry date information can be found on outer carton.

If the carton contains blister strips that are labelled and contain Amlodipine 5 mg tablets, contact your dispensing pharmacy in the first instance. If the carton contains blister strips that are labelled and contain Ramipril 5 mg Capsules, you do not need to take further action.

If you are unsure or have any questions, please seek advice from your pharmacy or other healthcare professionals responsible for your care.

If you have an impacted pack or previously received this batch, (where known) and you believe you have taken the Amlodipine 5 mg Tablets that were included in error and are currently experiencing any side effects, then please seek immediate medical advice.

Please take the leaflet that came with your medicine and any remaining tablets with you to your pharmacy or GP practice.

Both medications are used to treat high blood pressure, however because your body may not be used to a different type of medicine, your blood pressure may become lower than normal and you may experience dizziness as a result of taking amlodipine.

For reference the description of the products from the Patient Information Leaflets (PILs) are as follows:

Ramipril 5 mg Capsules: Ramipril 5 mg Capsules are light grey and green gelatine capsules, marked with “R” on the cap and “5” on the body. Click here for PIL

Amlodipine 5 mg Tablets: Amlodipine 5 mg tablets are white to off white, round, tablets with “5” debossed on one side and plain on the other side – Click here for PIL

See below images showing the different medicines and where to find the batch number of the product and the identification of the incorrect blister strip.

Open the MHRA notice

Questions

Why has Ramipril 5mg capsules been recalled?

The MHRA has issued a notice about Ramipril 5mg capsules. The MHRA classifies medicines recalls from Class 1 (most serious) to Class 4 (caution in use). The notice below sets out the details.

How do I know if my medicine is affected?

Compare the batch code, expiry and date code on your pack with the details listed under “Check your product” on this page. Only items that match are covered by the notice.

What should I do now?

Keep taking your medicine unless a healthcare professional tells you otherwise. Check the batch number and expiry date on your pack against the list on this page.

Do I need a new prescription?

If your pack is affected, your pharmacy can usually exchange it for an unaffected batch or another suitable product. Prescription medicines are replaced through your pharmacy or prescriber; you do not need to buy a new supply yourself. Many recalls are made at pharmacy or wholesaler level and do not require patients to act. The notice says which level applies.

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