Regulatory Updates

Omega Pharma Ltd is recalling specific batches of Napralief 250mg gastro‑resistant tablets because sections of the patient information leaflet and carton labeling are missing.

The UK Medicines and Healthcare products Regulatory Agency released a list of Field Safety Notices covering the period 11‑15 May 2026.

Teva UK Limited has identified a labeling mistake on the Ponlimsi (Denosumab) 60 mg pre‑filled syringe carton, which incorrectly states “For application to the skin” despite the product being licensed for subcutaneous injection.

The UK Medicines and Healthcare products Regulatory Agency released a list of Field Safety Notices covering 18‑22 May 2026.

The UK Medicines and Healthcare products Regulatory Agency released a list of Field Safety Notices covering the period 15 to 19 June 2026.

Flamingo Pharma UK Ltd notified the MHRA that some packs of Flucloxacillin Capsules BP 500 mg were supplied with the Patient Information Leaflet for Amoxicillin 500 mg, prompting a recall.

The UK Medicines and Healthcare products Regulatory Agency released a list of Field Safety Notices issued between 13 and 17 July 2026.

The FDA reports a labeling mixup where Famotidine 20 mg tablets may be mislabeled as Carvedilol Phosphate ER capsules, along with other products.

The FDA has initiated a recall after an inspection revealed GMP violations that could compromise product sterility.

The UK Medicines and Healthcare products Regulatory Agency (MHRA) released a series of Field Safety Notices between 1 and 5 June 2026, outlining safety actions for several medicines and medical devices.