MHRA Class 3 Medicines Recall: Napralief 250mg Gastro-Resistant Tablets (Omega Pharma Ltd)
Update 24/04/2026: Perrigo supplied the incorrect expiry date for one of the batches. This has been corrected in the table below, highlighted in red.
MHRA Class 3 Medicines Recall: Napralief 250mg Gastro-Resistant Tablets (Omega Pharma Ltd)
Drug Alert Number: EL(25)A/21
Date issued: 23 April 2026
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.
Medicine Details
Product name: Napralief 250mg Gastro-Resistant Tablets (PL: 02855/0340).
Active ingredient: naproxen
SNOMED code: N/A
GTIN: 05012616268236
Affected Lot Batch Numbers
| Batch number | 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 | 31/07/2028 | 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.
View the full alert here.
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.
