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
85 items · page 4 of 4. Showing the community pharmacy view.
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RecallClass 3 · Action within 5 days
Class 3 Medicines Recall: Activase Pharmaceuticals Limited, Prednisolone 5mg Soluble Tablets, EL(25)A/54
Activase Pharmaceuticals Limited is recalling two batches of Prednisolone 5mg Soluble Tablets as a precautionary measure due to a limited number of reports of blister pockets becoming swollen over time.
GOV.UK notice Every medicines recall is shown.
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RecallClass 2 · Action within 48 hours
Class 2 Medicines Recall: Hameln Pharma Ltd, Clarithromycin 500 mg powder for concentrate for solution for infusion, EL(25)A/53
Hameln Pharma Ltd is recalling certain batches of Clarithromycin 500 mg powder for concentrate for solution for infusion.
GOV.UK notice Every medicines recall is shown.
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RecallClass 4 · Caution in use
Class 4 Medicines Defect Notification: Flamingo Pharma UK Ltd, Amitriptyline Hydrochloride 10mg, 25mg, 50mg Tablets, EL(25)A/52
Flamingo Pharma UK Ltd has informed the MHRA that the Patient Information Leaflet (PIL) in the products listed in this notification do not contain all the required safety information.
GOV.UK notice Every medicines recall is shown.
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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".
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Roundup
MHRA Safety Roundup: November 2025
Summary of the latest safety advice for medicines and medical device users
GOV.UK notice Every MHRA monthly roundup is shown.
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RecallClass 4 · Caution in use
Class 4 Medicines Defect Notification: Special Concept Development UK Limited, Baclofen 10mg Tablets, EL(25)A/51
Special Concept Development UK Limited has informed the MHRA that the Patient Information Leaflet (PIL) for the batches listed in this notification do not contain the correct safety information.
GOV.UK notice Every medicines recall is shown.
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RecallClass 4 · Caution in use
Class 4 Medicines Defect Notification: Lexon UK Ltd, Moclobemide 150mg tablets, EL(25)A/50
Lexon UK Ltd has informed the MHRA that the Patient Information Leaflet (PIL) in the cartons for the batches listed in this notification is missing important updated safety information.
GOV.UK notice Every medicines recall is shown.
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RecallClass 3 · Action within 5 days
Class 3 Medicines Recall: Sun Pharmaceutical Industries Limited, Fingolimod SUN 0.5mg hard capsules, EL(25)A/49
Sun Pharma UK Limited is conducting a precautionary recall of a single batch of Fingolimod SUN 0.5 mg hard capsules due to reports of capsule breakage on removing from the blister. No other batches of Fingolimod SUN 0.5mg hard capsules are impacted.
GOV.UK notice Every medicines recall is shown.
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RecallClass 3 · Action within 5 days
Class 3 Medicines Recall: Sun Pharmaceutical Industries Limited, Atorvastatin 20mg and 80mg Film-coated Tablets, EL(25)A/48
Sun Pharma UK Limited are recalling the batches of tablets specified in the table as a precautionary measure due to failing dissolution test results reported during ongoing stability studies.
GOV.UK notice Every medicines recall is shown.
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RecallClass 3 · Action within 5 days
Class 3 Medicines Recall: Zambon SpA, Emylif 50mg orodispersible film, EL(25)A/47
Zambon SpA is recalling an affected batch as a precautionary measure due to out of specification results for unknown impurities during ongoing stability testing.
GOV.UK notice Every medicines recall is shown.
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.