Napralief 250mg Gastro-Resistant Tablets Class 3 Recall – Missing PIL Text
Summary
Omega Pharma Ltd is recalling three specific batches of Napralief 250mg Gastro-Resistant Tablets (B51496, B51497, B51102) distributed between December 2025 and February 2026, due to missing dosage and safety text in Section 2 and Section 3 of the Patient Information Leaflet and on the carton packaging. Pharmacies and wholesalers are required to stop supplying affected batches immediately, quarantine all stock, and return it to suppliers using approved processes. No further patient action is required as this is a precautionary recall at pharmacy and wholesaler level.
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 Ltd has initiated a Class 3 precautionary recall for Napralief 250mg Gastro-Resistant Tablets due to missing mandatory text in Section 2 and Section 3 of the Patient Information Leaflet and on the carton packaging. The missing text includes specific dosing instructions for adults aged 18-50 years and a maximum daily dose warning. Healthcare professionals at pharmacy and wholesaler level must immediately cease supplying the affected batches B51496, B51497, and B51102, quarantine all remaining stock, and process returns through normal supplier channels. Patients are advised that no further action is required on their part but should be aware that the PIL and carton in certain batches do not contain the most current safety information and should refer to the correct information provided in the recall notice.
What to do next
- Stop supplying the above batches immediately. Quarantine all stock and return it to your supplier using your supplier's approved process.
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.
Class 3 Medicines Recall: Omega Pharma Ltd, Napralief 250mg Gastro-Resistant Tablets, EL(26)A/21
Omega Pharma Ltd is recalling specific batches of Napralief 250mg Gastro-Resistant Tablets due to missing text in Section 2 and Section 3 of the Patient Information Leaflet (PIL) and on the Carton in packs of Napralief 250mg Gastro-resistant tablets.
From: Medicines and Healthcare products Regulatory Agency Published 23 April 2026 Message type: Medicines recall/notification Medical specialty: Dispensing GP practices and Pharmacy Issued: 23 April 2026
DMRC reference number
DMRC- 39001103
Marketing Authorisation Holder
Omega Pharma Ltd
Medicine Details
Napralief 250mg Gastro-Resistant Tablets
PL: 02855/0340
Active ingredient: naproxen
SNOMED code: N/A
GTIN: 05012616268236
Affected Lot Batch Numbers
| Batch No. | Expiry Date | Pack Size | First Distributed |
|---|---|---|---|
| B51496 | 31/10/2028 | 9 Tablets | 31/12/2025 |
| B51497 | 31/10/2028 | 9 Tablets | 03/02/2026 |
| B51102 | 31/10/2028 | 9 Tablets | 23/12/2025 |
Background
Omega Pharma Ltd is recalling specific batches of Napralief 250mg Gastro-Resistant Tablets due to missing text in Section 2 and Section 3 of the Patient Information Leaflet (PIL) and on the Carton in packs of Napralief 250mg Gastro-resistant tablets.
The Carton is missing the following wording:
- Adults (18-50 years): On the first day take two tablets, followed by one tablet 6-8 hours later, if needed. If required on the second and third day, take one tablet every 6-8 hours.
- Do not take more than three tablets a day. The PIL (Patient Information Leaflet) is missing the following wording highlighted in bold:
Advice for Healthcare Professionals:
Stop supplying the above batches immediately. Quarantine all stock and return it to your supplier using your supplier’s approved process.
Advice for Patients:
Do not take more than three tablets per day.
Patients should be aware that the Patient Information Leaflet (PIL) and Carton in certain batches of Napralief 250mg Gastro-resistant tablets do not contain the most up to date safety information and should refer to the correct information listed above.
No further action is required by patients. This recall is being undertaken as a precautionary measure and applies at Pharmacy and Wholesaler level.
Patients who experience adverse reactions or have any questions about their 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, stock control queries and information on this product, please email UKLOcustomerservice@perrigo.com or call +44 0203 598 9603.
Recipients of this Medicines Recall should bring it to the attention of relevant contacts by copy of this notice. NHS regional teams are asked to forward this to community pharmacists and dispensing general practitioners for information.
Yours faithfully
Defective Medicines Report Centre
10 South Colonnade
Canary Wharf
London
E14 4PU
Telephone +44 (0)20 3080 6574
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Class 3 Medicines Recall: Omega Pharma Ltd, Napralief 250mg Gastro-Resistant Tablets, EL(26)A/21
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Published 23 April 2026
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