MHRA Class 2 Medicines Recall: Ramipril 2.5mg capsules (Crescent Pharma Limited)

MHRA Class 2 Medicines Recall: Sertraline 100mg film-coated tablets (Amarox Limited)

Drug alert number: EL(26)A/25

Date issued: 28 May 2026

Crescent Pharma Limited is initiating a precautionary recall of one batch of Ramipril 2.5 mg Capsules following the identification of a potential packaging error at the manufacturing site.

DMRC reference number: DMRC-39617807

Company name: Crescent Pharma Limited

Medicine Details

Ramipril 2.5 mg Capsules (PL: 20416/0295)

Active ingredient: ramipril

SNOMED code: 38578211000001109

GTIN: 05017123670138

Affected Lot Batch Numbers:

Background

Crescent Pharma Limited is initiating a precautionary recall of one batch of Ramipril 2.5 mg Capsules following the identification of a potential packaging error at the manufacturing site. One complaint has been received to date, in which a sealed carton of Ramipril 2.5 mg Capsules (Batch No. GR155023) was found to contain two blister packs of Ramipril 10 mg Capsules (Batch No. GR175026). Both batches were manufactured at the same site, and the issue appears to have occurred during the secondary packaging process for Batch GR155023.

Please note this is a Class 2 Patient, Pharmacy and Wholesaler level recall.

Please note this is a Class 2 Patient, Pharmacy and Wholesaler level recall.

Advice for Healthcare Professionals

Stop supplying the impacted batch of Ramipril 2.5mg Capsules (batch number GR155023) immediately. Quarantine all remaining stock and return it to your supplier using your approved process

Consideration of the following patient communication should be considered within 48 hours of the alert and actioned within 5 working days:

• if batch/product traceability information is available, healthcare professionals involved in dispensing medicinal products should contact all patients who have been dispensed the impacted product and ask them to inspect the packs they have in their possession
• if batch/product traceability information is not available, pharmacists should identify all patients dispensed this product between 16 Jan 2026 and 22 May 2026. Attempts should be made to contact patients who have been dispensed the impacted product within the last 28 days as a priority
• any patients with impacted packs should be told to stop taking them immediately, return them to the pharmacy and contact their GP practice. Patients with non-impacted packs (majority of patients) should be informed they may continue to take the capsules from this batch
• where patients are identified with a defective pack they should be told to contact their prescriber responsible for their care to discuss treatment review and if a new prescription is required for ongoing resupply

Ramipril is a standard anti-hypertensive used in the treatment of hypertension, kidney disease and heart failure. The key risk associated with this defect is unintentional overdosing, where patients prescribed Ramipril 2.5 mg capsules may receive 10 mg capsules. Signs and symptoms may include feeling lightheaded, fainting, fatigue, or altered kidney function and be more serious for at risk or vulnerable patients.

Healthcare professionals should be aware that only the Ramipril 2.5mg Capsules batch stated in this notification is impacted.

View the alert here.

Advice for Healthcare Professionals to Provide to Patients

Some cartons of Ramipril 2.5mg Capsules, manufactured by Crescent Pharma Limited, may contain blister strips of Ramipril 10 mg Capsules and are being recalled at the pharmacy level as a precautionary measure.

If you were prescribed Ramipril 2.5 mg Capsules, and received a Crescent pack with batch number GR155023, please check the blister strips inside (the batch number and expiry date information can be found on outer carton, see the images in Annex 1).

• if the carton contains blister strips that are labelled as Ramipril 2.5 mg Capsules, you do not need to take further action and may continue to take the capsules
• if the carton contains a blister strip that is labelled as Ramipril 10 mg capsules, do not take the medicine, contact your pharmacy
• if you are unsure or have any questions, please seek advice from your pharmacy or other healthcare professionals responsible for your care
• if you believe you have taken the Ramipril 10 mg Capsules and are currently experiencing any side effects such as feeling lightheaded, fainting being fatigued, then please seek immediate medical advice (Please take the leaflet that came with your medicine and any remaining capsules with you to your pharmacy or GP practice)

Both strengths are used to treat high blood pressure, heart failure and kidney disease. Any possible impact of taking a higher dose of ramipril should be assessed by your healthcare professional to determine whether any examination or tests are needed.

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

Ramipril 2.5 mg Capsules: Capsules are light grey and light green capsules, marked with “R” on the cap and “2.5” on the body.

Ramipril 10 mg Capsules: Capsules are light grey and dark green capsules, marked with “R” on the cap and “10” on the body.

Images showing the different medicines and where to find the batch number of the product and the identification of the incorrect blister strip are included in Annex 1.

Annex 1

Ramipril 2.5 mg Capsules – Batch GR155023 (Outer carton, correct blister/capsule and BN/Exp Date information)

Ramipril 10mg Capsule – Batch GR175026 (Representing images of incorrect blister strip inside 2.5 mg pack)

Representing images of incorrect Capsule in 2.5mg pack

Patients who experience adverse reactions or have any questions about the medication should seek medical attention. Any suspected adverse reactions should also be reported via the MHRA Yellow Card scheme.

Additional information

For all medical information enquiries, please email medinfo@crescentpharma.com or telephone +44 1217901596.