Precautionary Recall of Napralief 250mg, 3 Batches, Missing Patient Safety Information
Summary
Omega Pharma Limited is recalling three batches of Napralief 250mg Gastro-Resistant Tablets (B51496, B51497, B51102) as a precautionary measure due to important safety and dosage information missing from the patient information leaflet and outer carton. The MHRA has advised healthcare professionals to stop supplying the affected batches and return all remaining stock to suppliers. Patients may continue using the medicine but should follow the correct dosage instructions: two tablets on the first day, followed by one tablet 6–8 hours later, then one tablet every 6–8 hours on subsequent days, for no more than three days.
“Napralief 250mg is considered safe when used in line with the correct dosage instructions.”
About this source
The Medicines and Healthcare products Regulatory Agency is the UK's medicines and medical devices regulator. MHRA publications include drug safety alerts, device field safety notices, Class 1-4 defect recalls, guidance updates, and the monthly medicines shortage list. Around 55 publications a month. Device field safety notices in particular are useful because MHRA often publishes them hours before other European regulators (ANSM, BfArM) surface the same recall. Watch this if you manufacture or distribute medicines or medical devices in the UK and EU, run a hospital pharmacy, advise on MHRA licensing, or follow post-market surveillance signals across European markets.
What changed
Omega Pharma Limited has issued a precautionary recall for three batches of Napralief 250mg Gastro-Resistant Tablets (batch numbers B51496, B51497, and B51102) after the MHRA identified that key safety and dosage information was absent from both the patient information leaflet and outer carton. The missing information includes the maximum daily dose of three tablets, specific day-one dosing instructions (two tablets initially, then one tablet 6–8 hours later), warnings about visual disturbances requiring eye examination, guidance on stopping treatment 48 hours before blood or urine tests, and alerts regarding serious allergic reactions, heart problems, autoimmune conditions, and potential skin reactions. Healthcare professionals and distributors holding stock of the affected batches must immediately cease supply and arrange return to the supplier. Patients in possession of these batches may continue use but should follow the correct dosing schedule and seek medical advice if they experience any adverse effects.
What to do next
- Healthcare professionals should stop supplying the affected batches and return all remaining stock to their suppliers.
Archived snapshot
Apr 23, 2026GovPing captured this document from the original source. If the source has since changed or been removed, this is the text as it existed at that time.
Press release
Precautionary recall of medication used for pain and inflammation due to incomplete patient information
Specific batches of Napralief 250mg Gastro‑Resistant Tablets are being recalled because important safety and dosage information is missing from both the patient information leaflet and the outer carton.
From: Medicines and Healthcare products Regulatory Agency Published 23 April 2026
Omega Pharma Limited is recalling specific batches of Napralief 250mg Gastro-Resistant Tablets as a precautionary measure due to important safety and dosage information being missing from the patient information leaflet (PIL) and outer carton.
Napralief 250mg contains the active ingredient naproxen and is a non-steroidal anti-inflammatory drug (NSAID) used to treat muscle or joint pain, such as sprains and strains, inflammation caused by sporting injuries, lower back pain, neck pain or pain in the wrists or feet. It is also used to treat period pain.
Three batches are affected by this recall. These can be identified by checking the packaging for batch numbers B51496, B51497, and B51102.
The affected cartons do not include the instruction that patients must not take more than three tablets a day, which is a key dosage safety message intended to prevent overuse.
In addition, the PIL is missing dosage instructions which state that on the first day patients should take two tablets, followed by one tablet 6-8 hours later. For the second and third day of treatment, if needed, one tablet (250mg) should be taken every 6–8 hours.
The PIL is also missing advice that patients should have an eye examination if they develop visual disturbances, warnings that serious allergic reactions can occur even in people with no previous allergy to painkillers, and guidance to inform a doctor if blood or urine tests are needed, as treatment may need to be stopped 48 hours before testing.
In addition, some information relating to heart problems and associated risk factors, certain autoimmune or mixed connective tissue diseases, and potential serious skin reactions is also missing. As a result of these omissions, patients may not receive the full information required to use the medicine safely.
Dr Alison Cave, MHRA Chief Safety Officer, said:
“Napralief 250mg is considered safe when used in line with the correct dosage instructions. Although small unintentional dosing mistakes are usually not harmful, complete and accurate safety information is essential to help ensure patients use their medicine correctly.
“Patients can continue to use the medicine safely in line with the correct safety and dosage instructions. Patients should take two tablets on the first day, followed by one tablet 6-8 hours later. For the second and third day of treatment, if needed, one tablet should be taken every 6–8 hours. Napralief should not be taken for more than three days.”
Patients experiencing any adverse effects or with questions about their medication should seek medical advice. Any suspected adverse reactions should also be reported via the MHRA Yellow Card scheme.
The MHRA has advised healthcare professionals to stop supplying the affected batches and return all remaining stock to their suppliers.
Notes to editors
- Please see MHRA’s Class 3 recall for further information.
- The MHRA is responsible for regulating all medicines and medical devices in the UK by ensuring they work and are acceptably safe. All our work is underpinned by robust and fact-based judgements to ensure that the benefits justify any risks.
- The MHRA is an executive agency of the Department of Health and Social Care.
- For media enquiries, please contact the newscentre@mhra.gov.uk, or call on 020 3080 7651.
Share this page
The following links open in a new tab
Updates to this page
Published 23 April 2026
Mentioned entities
Parties
Related changes
Get daily alerts for MHRA Guidance & Safety
Daily digest delivered to your inbox.
Free. Unsubscribe anytime.
Source
About this page
Every important government, regulator, and court update from around the world. One place. Real-time. Free. Our mission
Source document text, dates, docket IDs, and authority are extracted directly from MHRA.
The summary, classification, recommended actions, deadlines, and penalty information are AI-generated from the original text and may contain errors. Always verify against the source document.
Classification
Who this affects
Taxonomy
Browse Categories
Get alerts for this source
We'll email you when MHRA Guidance & Safety publishes new changes.
Subscribed!
Optional. Filters your digest to exactly the updates that matter to you.