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
51 items · page 1 of 3. Showing the community pharmacy view.
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RecallClass 2 · Action within 48 hours
Class 2 Medicines Recall: Accord-UK Ltd, Lercanidipine Hydrochloride 10mg Film-Coated Tablets, EL(26)A/45
Accord-UK Ltd is recalling one batch of Lercanidipine Hydrochloride 10mg Tablets due to a packaging mix-up involving the incorrect strength.
GOV.UK notice Every medicines recall is shown.
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RecallClass 2 · Action within 48 hours
Class 2 Medicines Recall: Advanz Pharma Limited, Mynzepli 40 mg/mL solution for injection in pre-filled syringe, EL(26)A/44
Advanz Pharma Limited are recalling specified batches of Mynzepli 40 mg/mL solution for injection in pre-filled syringe as a precautionary measure.
GOV.UK notice Every medicines recall is shown.
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RecallClass 2 · Action within 48 hours
Class 2 Medicines Recall: Xeal Pharma, Clopidogrel Oral Liquids (all strengths), EL(26)A/43
Xeal Pharma have informed MHRA that all strengths of their Clopidogrel Oral Suspension and Clopidogrel Oral Solution products contain less than the labelled amount of clopidogrel.
GOV.UK notice Every medicines recall is shown.
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RecallClass 2 · Action within 48 hours
Class 2 Medicines Recall: Norgine Pharmaceuticals Limited, Pedmarqsi 80 mg/mL solution for infusion, EL(26)A/42
Norgine Pharmaceuticals Limited is recalling the batches listed in the table due to risk of particulate matter being present in the product identified during routine stability investigations.
GOV.UK notice Every medicines recall is shown.
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RecallClass 3 · Action within 5 days
Class 3 Medicines Recall: Norgine Limited, MOVICOL Plain 13.7g powder for oral solution, EL(26)A/41
Norgine Limited is recalling specific batches of product as a precautionary measure due to some units containing the incorrect amounts of active ingredients.
GOV.UK notice Every medicines recall is shown.
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RecallClass 4 · Caution in use
Class 4 Medicines Defect Notification: B. Braun Melsungen AG, Meropenem 1000 mg powder and solvent for solution for infusion, EL(26)A/39
B. Braun Melsungen AG has notified the MHRA that errors have been identified in the Patient Information Leaflet (PIL) included in some batches of Meropenem 1000 mg powder and solvent 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: Martindale Pharmaceuticals Ltd, Clobazam Martindale Pharma 5 mg/5 mL and 10 mg/5 mL Oral Suspension 150ml, EL(26)A/38
Martindale Pharmaceuticals has informed the MHRA of an error with the linear barcode of some batches of Clobazam 5mg/5mL and 10mg/5mL Oral Suspension 150mL.
GOV.UK notice Every medicines recall is shown.
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RecallClass 2 · Action within 48 hours
Class 2 Medicines Recall: Zentiva Pharma UK Limited, Fingolimod Zentiva 0.5 mg Capsules, EL(26)A/37
Zentiva UK Pharma Limited are recalling one batch of Fingolimod Zentiva 0.5 mg Capsules (BN 4L01372H) as a precautionary measure due to a potential risk of contamination with metal particles.
GOV.UK notice Every medicines recall is shown.
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RecallClass 4 · Caution in use
Class 4 Medicines Defect Notification: Neuraxpharm UK Ltd, Tuzulby prolonged-release chewable tablets, EL(26)A/36
Neuraxpharm UK Ltd has informed the MHRA of missing safety information in the Patient Information Leaflet (PIL) and Summary of Product Characteristics (SmPC) for certain batches of Tuzulby prolonged release 20mg, 30mg and 40mg chewable tablets.
GOV.UK notice Every medicines recall is shown.
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RecallClass 4 · Caution in use
Class 4 Medicines Defect Notification: Macarthys Laboratories Ltd T/A Martindale Pharma, Xaggitin XL Prolonged-release Tablets, EL(26)A/35
Macarthys Laboratories Ltd T/A Martindale Pharma has notified the MHRA of a manufacturing issue impacting several batches of Xaggitin XL Prolonged-release Tablets, due to the occurrence of incorrect tablet counts in the bottles.
GOV.UK notice Every medicines recall is shown.
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RecallClass 2 · Action within 48 hours
Class 2 Medicines Recall: Beckton Dickson UK Ltd, ChloraPrep 1mL applicator, EL(26)A/34
Becton Dickinson UK Ltd are recalling batches of ChloraPrep 2% w/v / 70% v/v cutaneous solution 1mL applicators due to a potential breach of sterility in the packaging process.
GOV.UK notice Every medicines recall is shown.
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RecallClass 2 · Action within 48 hours
Class 2 Medicines Recall: Bristol Laboratories Limited, Phenoxymethylpenicillin 250 mg/5ml Sugar free Oral Solution BP, EL(26)A/33
Bristol Laboratories Limited is recalling one batch (7124002) of Phenoxymethylpenicillin 250 mg/5 ml Oral Solution Sugar Free due to product labelling issues.
GOV.UK notice Every medicines recall is shown.
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RecallClass 4 · Caution in use
UPDATE: Class 4 Medicines Defect Notification: Relonchem Limited, Gabapentin Relonchem 50mg/ml Oral Solution, EL(26)A/31
Relonchem Limited have informed the MHRA that particles have been observed inside some bottles of Gabapentin Relonchem Oral Solution, identified through a customer complaint.
GOV.UK notice Every medicines recall is shown.
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RecallClass 3 · Action within 5 days
Class 3 Medicines Recall: Flamingo Pharma UK Ltd, Flucloxacillin Capsules BP 500mg, EL(26)A/32
Flamingo Pharma UK Ltd have informed the MHRA that certain packs of Flucloxacillin Capsules BP 500mg contain the incorrect PIL. The affected packs contain the PIL for Amoxicillin 500mg Capsules instead of the PIL for Flucloxacillin BP 500mg Capsules.
GOV.UK notice Every medicines recall is shown.
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RecallClass 4 · Caution in use
Class 4 Medicines Defect Notification: Brancaster Pharma Limited, Benzylpenicillin benzathine 1.2 Million I.U. and 2.4 Million I.U. powder for suspension for injection, EL(26)A/30
Brancaster Pharma Limited has informed the MHRA that the Patient Information Leaflet (PIL) in the cartons for the batches listed in this notification were released with an outdated PIL.
GOV.UK notice Every medicines recall is shown.
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RecallClass 3 · Action within 5 days
Class 3 Medicines Recall: Orbit Pharma Limited, Cyclizine Lactate 50 mg/ml Solution for injection, EL(26)A/29
Orbit Pharma Limited is recalling a specific batch of Cyclizine Lactate 50 mg/ml Solution for injection as a precautionary measure due to Good Manufacturing Practice (GMP) deficiencies identified at the manufacturing site.
GOV.UK notice Every medicines recall is shown.
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RecallClass 4 · Caution in use
Class 4 Medicines Defect Notification: Cadila Pharmaceuticals Limited, Mirtazapine 30mg Tablets, EL(26)A/28
Cadila Pharmaceuticals Limited has informed the MHRA of an error with the European Article Number (EAN) barcode on the cartons of a batch of Mirtazapine 30mg Film-Coated Tablets distributed in Crescent Pharma Limited livery.
GOV.UK notice Every medicines recall is shown.
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RecallClass 4 · Caution in use
Class 4 Medicines Defect Notification: Teva UK Ltd, Ponlimsi (Denosumab) 60mg Solution for Injection in Pre-filled Syringe, EL(26)A/27
Teva UK Limited is reporting a labelling error on the carton for Ponlimsi (Denosumab) 60mg Solution for injection in Pre-filled Syringe. The carton states “For application to the skin” when the product is licensed for subcutaneous use.
GOV.UK notice Every medicines recall is shown.
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RecallClass 2 · Action within 48 hours
Class 2 Medicines Recall: Becton Dickinson UK Ltd, ChloraPrep 2% 1mL and ChloraPrep Frepp 2% 1.5mL applicators, EL(26)A/26
Becton Dickinson UK Ltd are recalling batches of ChloraPrep 2% 1mL applicators and ChloraPrep Frepp 2% 1.5 mL applicators due to a potential breach of sterility in the packaging process.
GOV.UK notice Every medicines recall is shown.
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RecallClass 2 · Action within 48 hours
Class 2 Medicines Recall: Crescent Pharma Limited, Ramipril 2.5 mg Capsules, EL(26)A/25
Crescent Pharma Limited is initiating a precautionary recall of one batch of Ramipril 2.5 mg Capsules following the identification of a potential packaging error at the manufacturing site.
GOV.UK notice Every medicines recall is shown.
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RecallClass 4 · Caution in use
Class 4 Medicines Defect Notification: Fresenius Medical Care Deutschland GmbH, balance 2.3% glucose, 1.25 mmol/l calcium, solution for peritoneal dialysis, EL(26)A/24
Fresenius Medical Care Deutschland GmbH have identified an error in the Braille printed on the outer label.
GOV.UK notice Every medicines recall is shown.
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RecallClass 4 · Caution in use
Class 4 Medicines Defect Notification: Milpharm Limited, Loperamide hydrochloride 2 mg Orodispersible Tablets, EL(26)A/23
Milpharm Limited has identified a discrepancy in the Patient Information Leaflet (PIL) approved for Loperamide hydrochloride 2 mg Orodispersible Tablets.
GOV.UK notice Every medicines recall is shown.
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RecallClass 2 · Action within 48 hours
Class 2 Medicines Recall: Amarox Limited, Sertraline 100mg film-coated tablets, EL(26)A/22
Amarox Limited is recalling one batch of Sertraline 100 mg film-coated tablets as a precautionary measure due to an error at the manufacturing site.
GOV.UK notice Every medicines recall is shown.
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RecallClass 3 · Action within 5 days
Class 3 Medicines Recall: Omega Pharma Ltd, Napralief 250mg Gastro-Resistant Tablets, EL(26)A/21
Omega Pharma Ltd is recalling specific batches of Napralief 250mg Gastro-Resistant Tablets due to missing text in Section 2 and Section 3 of the Patient Information Leaflet (PIL) and on the Carton in packs of Napralief 250mg Gastro-resistant tablets.
GOV.UK notice Every medicines recall is shown.
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RecallClass 4 · Caution in use
Class 4 Medicines Defect Notification: Doncaster Pharma Limited, Hiprex 1g tablets, EL(26)A/20
Doncaster Pharma Limited has informed the MHRA of an error related to the Braille embossing on the outer packaging of certain parallel imported batches of Hiprex 1 g tablets (POM).
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.