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MHRA Updates

The latest guidances, approvals, and safety alerts from MHRA, curated by automated regulatory intelligence.

OTHER
Class 4 Medicines Defect Notification: Neuraxpharm UK Limited, Levetiracetam Neuraxpharm granules for oral solution in sachet, EL(26)A/40
MHRA (UK) • Published: Oct 1, 2026

Class 4 medicines defect notification submitted by Neuraxpharm UK Limited indicates that a review of the approved Patient Information Leaflet (PIL) has…

neurology
safety
+1
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OTHER
Field Safety Notices: 21 to 25 September 2026
MHRA (UK) • Published: Sep 29, 2026

Publishes the set of MHRA Field Safety Notices issued between 21 and 25 September 2026, signaling active post-market safety communications that sponsors…

safety
labeling
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OTHER
MHRA Safety Roundup: September 2026
MHRA (UK) • Published: Sep 29, 2026

Provides a curated safety update for medicines and medical device users, highlighting the latest safety advice issued by the MHRA.

safety
labeling
+3
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OTHER
Class 4 Medicines Defect Notification: B. Braun Melsungen AG, Meropenem 1000 mg powder and solvent for solution for infusion, EL(26)A/39
MHRA (UK) • Published: Sep 23, 2026

Notification of a Class 4 defect relating to errors in the Patient Information Leaflet (PIL) for certain batches of meropenem 1000 mg powder and solvent for…

infectious_disease
labeling
+1
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OTHER
Field Safety Notices: 14 to 18 September 2026
MHRA (UK) • Published: Sep 23, 2026

Publishes an MHRA listing of Field Safety Notices issued during 14–18 September 2026, indicating active pharmacovigilance and risk communication activities…

safety
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OTHER
Radiofrequency (RF) Safety Considerations for Wireless Cardiotocography (CTG) Monitoring Systems (DSI/2026/012)
MHRA (UK) • Published: Sep 17, 2026

Introduces heightened MHRA safety expectations for wireless cardiotocography (CTG) monitoring systems using RF telemetry channels, focusing on risks of signal…

cardiology
pediatrics
+5
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OTHER
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
MHRA (UK) • Published: Sep 17, 2026

Reports a Class 4 medicines defect notification to the MHRA concerning an error with the linear barcode for certain batches of Clobazam Martindale Pharma 5…

psychiatry
neurology
+3
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OTHER
National Patient Safety Alert: Patient hoists and slings (all types): risk of death and serious harm from falls (NatPSA/2026/005/MHRA)
MHRA (UK) • Published: Sep 16, 2026

Highlights ongoing fatal and serious harms from falls during patient transfers/repositioning involving patient hoists and slings, based on incident review and…

safety
clinical
+1
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OTHER
Field Safety Notices: 7 September to 11 September 2026
MHRA (UK) • Published: Sep 14, 2026

Publishes an official bulletin-style listing of Field Safety Notices issued over 7–11 September 2026, signalling active MHRA safety communications to industry…

safety
labeling
+2
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OTHER
Field Safety Notices: 31 August to 4 September 2026
MHRA (UK) • Published: Sep 9, 2026

Publishes a list of MHRA Field Safety Notices issued between 31 August and 4 September 2026, signalling ongoing post-market safety communications that may…

safety
labeling
+3
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OTHER
Field Safety Notices: 24 to 28 August 2026
MHRA (UK) • Published: Sep 3, 2026

Publishes a weekly list of MHRA Field Safety Notices issued between 24 and 28 August 2026, which may indicate ongoing device safety actions across the market.

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OTHER
Filters should be used during the administration of Parenteral Nutrition for patients in all care settings DSI/2026/011
MHRA (UK) • Published: Sep 2, 2026

Requires that filters be used during the administration of parenteral nutrition across all care settings to mitigate risks of serious adverse incidents.

clinical
safety
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OTHER
Cobalt-chrome modular neck hip replacements: risk of metal-wear effects and revision surgery (DSI/2026/010)
MHRA (UK) • Published: Aug 26, 2026

Highlights MHRA safety concerns for cobalt-chrome modular neck hip stem components, citing increased wear and corrosion risks that could translate into a…

manufacturing
quality
+3
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OTHER
MHRA Safety Roundup: August 2026
MHRA (UK) • Published: Aug 25, 2026

Summarises MHRA’s latest safety-related advice affecting how medicines and medical device users should interpret ongoing risk information.

safety
labeling
+3
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OTHER
NGPod pH testing device: quarantine and dispose of all devices (DSI/2026/009)
MHRA (UK) • Published: Aug 24, 2026

Withdrawal from the UK market of the NGPod handheld pH testing device (NGPod handheld device and NGPod sensor) because the manufacturer has ceased trading in…

gastroenterology
respiratory
+5
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OTHER
Field Safety Notices: 17 to 21 August 2026
MHRA (UK) • Published: Aug 24, 2026

Compilation of MHRA Field Safety Notices issued between 17 and 21 August 2026, signaling active communications on product-related risks and/or corrective…

safety
manufacturing
+3
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OTHER
Rectal catheters sold for personal use (gas and colic relievers): Do not use in infants, including for the treatment of colic, gas-related discomfort or constipation (DSI/2026/008)
MHRA (UK) • Published: Aug 20, 2026

Rectal gas and colic reliever catheters sold for personal use are not to be used in infants for any indication, including colic, gas-related discomfort, or…

pediatrics
gastroenterology
+1
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OTHER
Class 2 Medicines Recall: Zentiva Pharma UK Limited, Fingolimod Zentiva 0.5 mg Capsules, EL(26)A/37
MHRA (UK) • Published: Aug 20, 2026

Initiates a precautionary Class 2 recall of one batch of Fingolimod Zentiva 0.5 mg Capsules due to a potential risk of contamination with metal particles.

neurology
immunology
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OTHER
Field Safety Notices: 10 to 14 August 2026
MHRA (UK) • Published: Aug 18, 2026

Publishes a listing of MHRA Field Safety Notices issued during 10 to 14 August 2026, which may indicate ongoing safety actions affecting marketed products.

safety
labeling
+3
View update →
OTHER
Field Safety Notices: 13 to 17 July 2026
MHRA (UK) • Published: Aug 18, 2026

Field Safety Notices issued between 13 and 17 July 2026 indicate MHRA communications to support risk awareness and corrective actions for specific product…

safety
labeling
+3
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