MHRA safety alerts and recalls
Every MHRA medicines recall, patient safety alert and Drug Safety Update, checked against GOV.UK every 2 hours from 07:00 to 19:00. Last checked 30 Oct, 17:00.
Pharmshark is not an official alerting route. Make sure your pharmacy receives alerts directly from the MHRA and through your organisation, and always act on the official GOV.UK notice.
Recalls needing action now
Class 1–3 recalls issued in the last 14 days and National Patient Safety Alerts issued in the last 30 days.
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RecallClass 2 · Action within 48 hoursClass 2 Medicines Recall: Accord-UK Ltd, Lercanidipine Hydrochloride 10mg Film-Coated Tablets, EL(26)A/45 Act on the official notice
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RecallClass 2 · Action within 48 hoursClass 2 Medicines Recall: Advanz Pharma Limited, Mynzepli 40 mg/mL solution for injection in pre-filled syringe, EL(26)A/44 Act on the official notice
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RecallClass 2 · Action within 48 hoursClass 2 Medicines Recall: Xeal Pharma, Clopidogrel Oral Liquids (all strengths), EL(26)A/43 Act on the official notice
What do the recall classes mean?
| Class | Action | The MHRA's definition |
|---|---|---|
| Class 1 | Immediate action | The defect presents a risk of death or disability. |
| Class 2 | Action within 48 hours | The defect may cause mistreatment or harm to the patient, but it is not life-threatening or serious. |
| Class 3 | Action within 5 days | The defect is unlikely to cause harm to the patient. |
| Class 4 | Caution in use | Usually minor defects in packaging or other printed materials. |
A Class 1 recall usually comes with a National Patient Safety Alert. Source: MHRA, safety communications.
All alerts
14 items. Showing the community pharmacy view.
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Drug Safety Update
#MedSafetyWeek (2 to 8 November 2026): Don't ignore suspected side effects, report them! Updates to the Yellow Card website and app
The annual #MedSafetyWeek campaign is taking place from 2 to 8 November 2026 to promote the importance of reporting side effects from medicines and medical device incidents. This year's theme is ‘Side effects: don't ignore them, report them!’
GOV.UK notice Shown because the MHRA tagged it "Pharmacy".
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Drug Safety Update
Antidepressants: new safety measures for all patients to improve communication of the risk of suicidal thoughts and behaviours and persistent sexual dysfunction
New safety measures are now being implemented to improve how the risks of suicidal thoughts and behaviours and persistent sexual dysfunction are communicated to patients taking antidepressant medications.
GOV.UK notice Shown because the MHRA tagged it "Pharmacy".
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Drug Safety Update
Filters should be used during the administration of Parenteral Nutrition for patients in all care settings
Administration of parenteral nutrition without a filter has been associated with a number of adverse incidents including an embolism which resulted in a fatal outcome.
GOV.UK notice Shown because the MHRA tagged it "Pharmacy".
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Drug Safety Update
Domperidone: new contraindication in patients with phaeochromocytoma due to the risk of severe hypertension
The product information has been updated for all domperidone products, to include a contraindication for patients with confirmed or suspected phaeochromocytoma (a rare tumour of the adrenal gland), due to the risk of episodes of severe hypertension.
GOV.UK notice Shown because the MHRA tagged it "Pharmacy".
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Drug Safety Update
ACE-inhibitors: Be aware of the distinction between bradykinin- and histamine-mediated angioedema, as treatment strategies differ significantly
Healthcare professionals should be aware of the potential for delayed onset of angioedema and the distinction between bradykinin- and histamine-mediated cases, as treatment strategies differ significantly and bradykinin-mediated angioedema does not respond to standard treatment.
GOV.UK notice Shown because the MHRA tagged it "Pharmacy".
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Drug Safety Update
Finasteride and Dutasteride – updated safety warnings for psychiatric side effects and sexual dysfunction
The MHRA has reviewed the evidence for finasteride and dutasteride and the risk of suicidal thoughts and behaviours and has recommended further measures to minimise this risk.
GOV.UK notice Shown because the MHRA tagged it "Pharmacy".
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Drug Safety Update
Nasal decongestant sprays and drops containing xylometazoline hydrochloride / oxymetazoline hydrochloride: increased risk of rebound congestion, rhinitis medicamentosa, and tachyphylaxis with overuse
There have been reports of worsening nasal congestion (rebound congestion) when the effects of nasal decongestant sprays or drops containing xylometazoline hydrochloride and oxymetazoline hydrochloride, wear off.
GOV.UK notice Shown because the MHRA tagged it "Pharmacy".
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Drug Safety Update
Falsified Mounjaro KwikPen 15mg pre-filled pens
A falsified version of Mounjaro (tirzepatide) KwikPen 15mg solution for injection has been found supplied through one online pharmacy in the UK. The falsified product is labelled with batch D873576 and applies to Mounjaro KwikPen 15mg solution for injection in pre-filled pen only.
GOV.UK notice Shown because the MHRA tagged it "Pharmacy".
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Drug Safety Update
Semaglutide (Wegovy, Ozempic and Rybelsus): risk of Non-arteritic Anterior Ischemic Optic Neuropathy (NAION)
Non-arteritic anterior ischemic optic neuropathy (NAION), a condition that can cause sudden deterioration in vision, usually in one eye at a time, has been very rarely reported in association with semaglutide in the treatment of type 2 diabetes, weight management and cardiovascular risk reduction. Patients reporting a…
GOV.UK notice Shown because the MHRA tagged it "Pharmacy".
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Drug Safety Update
GLP-1 receptor agonists and dual GLP-1/GIP receptor agonists: strengthened warnings on acute pancreatitis, including necrotising and fatal cases
The product information for all Glucagon-Like Peptide-1 (GLP-1) receptor agonists and dual GLP-1/glucose-dependent insulinotropic polypeptide (GIP) receptor agonists has been further updated to highlight the potential risk of severe acute pancreatitis with these products, including rare reports of necrotising and fata…
GOV.UK notice Shown because the MHRA tagged it "Pharmacy".
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Drug Safety Update
Isotretinoin – changes to prescribing guidance and additional risk minimisation measures
The Commission on Human Medicines (CHM) has endorsed changes to the risk minimisation measures for isotretinoin, following a review of the impact of the measures implemented in 2023. We ask healthcare professionals to review these new measures and supporting materials and integrate them into their clinical practice.
GOV.UK notice Shown because the MHRA tagged it "Pharmacy".
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Drug Safety Update
Improving Information Supplied with Gabapentinoids (Pregabalin/Gabapentin), Benzodiazepines and Z-Drugs
The MHRA has reviewed the warnings regarding addiction, dependence, withdrawal, and tolerance for gabapentin, pregabalin, benzodiazepines, and z-drugs. The findings (detailed in the Public Assessment Report) were that it was necessary to strengthen these warnings in the product information and on packaging to better …
GOV.UK notice Shown because the MHRA tagged it "General practice".
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Drug Safety Update
Rybelsus ® (semaglutide tablets): transition to new formulation and risk of medication error
There is a risk of patient harm arising through medication error during a transition period where the original and new formulation of Rybelsus ® tablets, which have different stated mg doses but are bioequivalent, will both be available on the market.
GOV.UK notice Shown because the MHRA tagged it "Pharmacy".
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Drug Safety Update
Mesalazine and idiopathic intracranial hypertension
Idiopathic intracranial hypertension (IIH) has been very rarely reported in patients treated with mesalazine. Following a recent review, warnings for IIH are being added to the product information for all mesalazine products.
GOV.UK notice Shown because the MHRA tagged it "Pharmacy".
Source: the MHRA on GOV.UK. Contains public sector information licensed under the Open Government Licence v3.0. Pharmshark is not affiliated with or endorsed by the MHRA.