UK regulator pulls Sandoz co-amoxiclav prescribing text over error that could double dose

Sandoz's co-amoxiclav oral suspension is without an official, published prescribing text in the UK after the Medicines and Healthcare products Regulatory Agency (MHRA) withdrew it on 5 November 2026. The agency's notification, reference EL(26)A/46, covers every batch of the 250/62.5 mg/5 mL powder, licensed as PL 04416/0515. No sales, market-share or financial impact is given in the material available, so the commercial cost to Sandoz is unknown.

The problem sits in the weight-based dosing instructions in Section 4.2 of the Summary of Product Characteristics (SmPC), which Sandoz Limited reported to the regulator as containing errors. Following them would produce roughly twice the intended recommended dose. The MHRA says the powder itself is unaffected, and the notice reports no manufacturing or quality fault. It sits in the agency's lowest-risk defect category.

The faulty document has been taken off the MHRA products site and the electronic medicines compendium (eMC). It will return only once Sandoz has been granted a variation to its marketing authorisation covering corrected text. Until then, Sandoz-supplied dosing information is set out in Annex 1 of the notification, and clinicians are told not to rely on the Sandoz SmPC for weight-adjusted doses.

The MHRA warns that overdose could increase known dose-related effects: gastrointestinal symptoms such as diarrhoea, nausea, vomiting and abdominal pain; dehydration and fluid or electrolyte disturbance; and hypersensitivity or other adverse reactions. It describes amoxicillin crystalluria, including acute renal injury or failure, as very rare and mainly associated with parenteral treatment. Patients should keep taking the medicine as prescribed and seek prompt medical advice if they think they received the higher dose and have symptoms. A post-publication note corrects the strength first shown in the notice's Medicine Details table; the DMRC reference is DMRC-41234128.