Archive for MHRA Updates
Class 2 Medicines Recall: Zaditen 0.25 mg/ml, eye drops, solution, Laboratoires Théa EL(25)A/34
Source: MHRA/Gov.uk 9.7.25 Laboratoires Théa trading as Thea Pharmaceuticals Limited have notified the MHRA of an out of specification event related to environmental monitoring during manufacturing, which may increase the...
Class 4 Medicines Defect Notification: Simvastatin 10mg Tablet, Crescent Pharma Ltd, EL(25)A/33
Source: MHRA.Gov.uk 3.7.25 Crescent Pharma Limited has informed the MHRA of an error with the European Article Number (EAN) barcode on the cartons of a batch of simvastatin 10 mg...
Class 3 Medicines Recall: Omeprazole 20 mg/15 ml Oral Solution, Glenmark Pharmaceuticals Europe Ltd, EL(25)A/30
Source: MHRA/Gov.uk 30.6.25 Glenmark Pharmaceuticals Europe Ltd is recalling a specific batch of Omeprazole Oral Solution as a precautionary measure due to an investigation following a customer complaint indicating precipitation...
Class 3 Medicines Recall: Tamoxifen 20mg Film-Coated Tablets, Wockhardt UK Ltd, EL(25)A/31
Source: MHRA/Gov.uk 30.6.25 Wockhardt UK Limited is recalling a batch as a precautionary measure following the identification of a dissolution failure during stability testing. DMRC reference number DMRC-35980389 Marketing Authorisation...
Class 2 Medicines Recall: Inhixa 12,000IU (120mg)/0.8mL solution for injection, Maxearn Limited, EL(25)A/27
Source: MGRA/Gov.uk 12.6.25 Maxearn Limited have informed the MHRA that the carton used to package two imported batches of Inhixa have been released to the market with a typographical error...
Class 4 Medicines Defect Notification: Dulcolax Adult 5 mg Gastro-resistant Tablets, Opella Healthcare UK, EL(25)A/26
Source: MHRA/ Gov.uk 10.6.25 Opella Healthcare UK LTD has informed the MHRA that there is an error on the artwork for the outer carton of Dulcolax Adult 5mg GR Tablets...
Class 2 Medicines Recall: Paracetamol 500mg Tablets, Chelonia Healthcare Limited, EL(25)A/25
Source: MHRA/Gov.uk 9.6.25 Chelonia Healthcare Limited is recalling specific batches of Paracetamol 500mg Tablets (100 pots) as a precautionary measure due to contamination following a small number of complaints of...
Class 4 Medicines Notification, Zentiva Pharma UK Limited, Various Products, EL(25)A/24
Source: MHRA/Gov.uk 2.6.25 Zentiva Pharma UK Limited has informed the MHRA of an issue related to batches of various soluble or effervescent tablets. DMRC reference number DMRC-35524103 Marketing Authorisation Holder...
Class 4 Medicines Notification, Chemidex Pharma Ltd, Various Products, EL(25)A/21
Source: MHRA / Gov.uk 13.5.25 Chemidex Pharma Ltd has informed the MHRA that the Patient Information Leaflet (PIL) in their topical steroid products does not contain all the required safety...
Class 4 Medicines Defect Notification: Chloramphenicol 1% w/w Eye Ointment, Blumont Pharma Limited, EL(25)A/20
Source: MHRA / Gov.uk 8.5.25 Blumont Pharma Limited has informed the MHRA of an error with the European Article Number (EAN) barcode on the cartons of the batch of Chloramphenicol...
Class 4 Medicines Defect Notification: Pregabalin 25mg, 50mg, 75mg, 100mg, 150mg, 200mg, 225mg, 300mg Capsules, Jubilant Pharmaceuticals NV, EL(25)A/19
Source: MHRA/Gov.uk 29.4.25 Jubilant Pharmaceuticals BV has informed the MHRA that the outer carton (box) of the product batches mentioned in this notification are missing the medicines legal classification for...
Class 4 Medicines Defect Notification: Brilique 90mg Tablets, EL(25)A/18
Source: Gov.uk / MHRA 24.4.25 G Pharma Ltd have informed the MHRA that there is an error in the spelling of the active ingredient included on the imported carton. The...
