tag:www.gov.uk,2005:/drug-device-alertsAlerts, recalls and safety information: medicines and medical devices about General practice2026-04-29T14:02:41+01:00HM Governmenttag:www.gov.uk,2005:/drug-device-alerts/mhra-safety-roundup-april-20262026-04-29T14:02:41+01:00MHRA Safety Roundup: April 2026Summary of the latest safety advice for medicines and medical device userstag:www.gov.uk,2005:/drug-device-alerts/class-2-medicines-recall-crescent-pharma-limited-ramipril-10mg-capsules-el-26-a-slash-192026-04-20T13:06:09+01:00Class 2 Medicines Recall: Crescent Pharma Limited, Ramipril 10mg capsules, EL(26)A/19Crescent Pharma Limited is recalling one batch of Ramipril 10mg Capsules as a precautionary measure due to a potential error at the manufacturing site. tag:www.gov.uk,2005:/drug-device-alerts/mhra-safety-roundup-march-20262026-03-31T14:01:53+01:00MHRA Safety Roundup: March 2026Summary of the latest safety advice for medicines and medical device userstag:www.gov.uk,2005:/drug-device-alerts/class-2-medicines-recall-regent-medical-limited-slash-molnlycke-health-care-hibiwash-500ml-el-26-a-slash-152026-03-23T16:32:53+00:00Class 2 Medicines Recall: Regent Medical Limited / Mölnlycke Health Care, Hibiwash 500ml, EL(26)A/15Mölnlycke Health Care are recalling specific batches of Hibiwash due to microbial contamination at the manufacturing facility, following routine weekly microbiological monitoring.tag:www.gov.uk,2005:/drug-device-alerts/mhra-safety-roundup-february-20262026-02-25T11:12:50+00:00MHRA Safety Roundup: February 2026Summary of the latest safety advice for medicines and medical device userstag:www.gov.uk,2005:/drug-device-alerts/national-patient-safety-alert-class-1-medicines-recall-notification-recall-of-quetiapine-oral-suspension-unlicensed-medicine-manufactured-by-eaststone-limited-due-to-a-potential-for-overdosing-natpsa-slash-2026-slash-002-slash-mhr2026-01-29T12:13:05+00:00National Patient Safety Alert: Class 1 Medicines Recall Notification: Recall of Quetiapine Oral Suspension (unlicensed medicine), manufactured by Eaststone Limited due to a potential for overdosing, NatPSA/2026/002/MHRAEaststone Limited is initiating a recall of all batches of quetiapine oral suspension products due to a potential risk of overdose, which could have consequences for the safety of patients.tag:www.gov.uk,2005:/drug-device-alerts/mhra-safety-roundup-january-20262026-01-27T14:00:25+00:00MHRA Safety Roundup: January 2026Summary of the latest safety advice for medicines and medical device userstag:www.gov.uk,2005:/drug-device-alerts/m6-c-artificial-cervical-disc-spinal-kinetics-llc-new-monitoring-requirements-for-the-risk-of-osteolysis2026-01-15T14:00:17+00:00M6-C Artificial Cervical Disc, Spinal Kinetics LLC: New monitoring requirements for the risk of osteolysis (DSI/2026/001)The MHRA has conducted an assessment following reports of osteolysis and early device failure in the literature and is issuing new monitoring requirements for patients implanted with the M6-C artificial cervical disc.tag:www.gov.uk,2005:/drug-device-alerts/mhra-safety-roundup-december-20252025-12-18T13:55:18+00:00MHRA Safety Roundup: December 2025Summary of the latest safety advice for medicines and medical device userstag:www.gov.uk,2005:/drug-device-alerts/mhra-safety-roundup-november-20252025-11-27T14:05:40+00:00MHRA Safety Roundup: November 2025Summary of the latest safety advice for medicines and medical device userstag:www.gov.uk,2005:/drug-device-alerts/mhra-safety-roundup-october-20252025-10-28T14:28:26+00:00MHRA Safety Roundup: October 2025Summary of the latest safety advice for medicines and medical device userstag:www.gov.uk,2005:/drug-device-alerts/bd-bodycomm-version-3-dot-3-software-used-for-bodyguard-infusion-pumps-bodyguard-t-and-t34-syringe-drivers-important-steps-to-manage-transition-to-windows-11-dsi-slash-2025-slash-0062025-10-06T14:03:14+01:00BD BodyComm™ version 3.3 software used for BodyGuard infusion pumps, BodyGuard-T and T34 syringe drivers: Important steps to manage transition to Windows 11 (DSI/2025/006)The BodyComm software currently uses Windows 10. Microsoft is transitioning to Windows 11 from 14 October 2025 which requires an updated cable to connect the pumps to the BodyComm software. These cables may not be available …tag:www.gov.uk,2005:/drug-device-alerts/mhra-safety-roundup-september-20252025-09-30T13:59:39+01:00MHRA Safety Roundup: September 2025Summary of the latest safety advice for medicines and medical device userstag:www.gov.uk,2005:/drug-device-alerts/profemur-cobalt-chrome-modular-neck-hip-replacements-higher-than-anticipated-risk-of-revision-surgery-metal-wear-effects-and-component-fracture-dsi-slash-2025-slash-0052025-09-04T10:07:02+01:00Profemur Cobalt Chrome Modular Neck Hip Replacements: Higher than anticipated risk of revision surgery, metal-wear effects and component fracture (DSI/2025/005)An MHRA investigation has found increased risks of wear and corrosion, including an increased occurrence of device fracture and revision surgery associated with cobalt chrome-containing Profemur modular neck hip stem compone…tag:www.gov.uk,2005:/drug-device-alerts/mhra-safety-roundup-august-20252025-08-28T14:59:53+01:00MHRA Safety Roundup: August 2025Summary of the latest safety advice for medicines and medical device userstag:www.gov.uk,2005:/drug-device-alerts/mhra-safety-roundup-july-20252025-07-31T14:42:07+01:00MHRA Safety Roundup: July 2025Summary of the latest safety advice for medicines and medical device userstag:www.gov.uk,2005:/drug-device-alerts/class-2-medicines-recall-chloraprep-1ml-clear-sterile-solution-slash-applicator-becton-dickinson-uk-ltd-el-25-a-slash-362025-07-28T10:59:26+01:00Class 2 Medicines Recall: ChloraPrep 1mL Clear Sterile Solution/Applicator, Becton Dickinson UK Ltd, EL(25)A/36Becton Dickinson UK Ltd has informed the MHRA that some units exhibit an open seal on the packaging of the applicator. This is linked to the Class 2 Medicines Notification EL(25)A/22. This defect could increase the risk of …tag:www.gov.uk,2005:/drug-device-alerts/trinity-biotech-premier-hb9210-hba1c-analyser-risk-of-positive-bias-and-updates-to-instructions-for-use-ifu-including-use-as-a-diagnostic-aid-in-diabetes-mellitus-dsi-slash-2025-slash-0032025-07-22T14:21:49+01:00Trinity Biotech Premier Hb9210™ HbA1c Analyser: Risk of Positive Bias and Updates to Instructions for Use (IFU), including use as a diagnostic aid in diabetes mellitus (DSI/2025/003)The MHRA has received reports describing a positive bias in HbA1c results delivered by the Trinity Biotech Premier Hb9210 HbA1c analyser, which has resulted in patients being incorrectly diagnosed as pre-diabetic or diabetic…tag:www.gov.uk,2005:/drug-device-alerts/class-3-medicines-recall-omeprazole-20-mg-slash-15-ml-oral-solution-glenmark-pharmaceuticals-europe-ltd-el-25-a-slash-302025-06-30T11:03:02+01:00Class 3 Medicines Recall: Omeprazole 20 mg/15 ml Oral Solution, Glenmark Pharmaceuticals Europe Ltd, EL(25)A/30Glenmark Pharmaceuticals Europe Ltd is recalling a specific batch of Omeprazole Oral Solution as a precautionary measure due to an investigation following a customer complaint indicating precipitation and discoloration of th…tag:www.gov.uk,2005:/drug-device-alerts/class-2-medicines-recall-depo-medrone-80-mg-in-2-ml-maxearn-limited-el-25-a-slash-292025-06-25T14:00:03+01:00Class 2 Medicines Recall: Depo-Medrone 80 mg in 2 mL, Maxearn Limited EL(25)A/29A batch of Depo-Medrone has been released to the market with an error. The vial over label incorrectly states that the total vial content is 40 mg in 1 mL, when the correct total vial content is 80mg in 2 mL (with a concentr…tag:www.gov.uk,2005:/drug-device-alerts/mhra-safety-roundup-june-20252025-06-24T15:42:44+01:00MHRA Safety Roundup: June 2025Summary of the latest safety advice for medicines and medical device userstag:www.gov.uk,2005:/drug-device-alerts/mhra-safety-roundup-may-20252025-06-13T15:11:47+01:00MHRA Safety Roundup: May 2025Summary of the latest safety advice for medicines and medical device userstag:www.gov.uk,2005:/drug-device-alerts/philips-respironics-bipap-a-series-ventilators-alarm-malfunction-and-risk-of-therapy-interruptions-in-ventilators-not-intended-for-life-support-dsi-slash-2024-slash-0062025-05-23T14:47:57+01:00Philips Respironics BiPAP A series ventilators: alarm malfunction and risk of therapy interruptions in ventilators not intended for life-support, DSI/2024/006Philips Respironics has issued a Field Safety Notice (FSN) relating to the Bilevel Positive Airway Pressure (BiPAP) A series ventilators. This relates to a Ventilator Inoperative alarm which could result in the potential los…tag:www.gov.uk,2005:/drug-device-alerts/mhra-safety-roundup-april-20252025-04-29T13:59:27+01:00MHRA Safety Roundup: April 2025Summary of the latest safety advice for medicines and medical device userstag:www.gov.uk,2005:/drug-device-alerts/class-2-medicines-recall-lercanidipine-hcl-20mg-tablets-recordati-industria-el-25-a-slash-172025-04-17T13:46:18+01:00Class 2 Medicines Recall: Lercanidipine HCl 20mg Tablets, Recordati Industria, EL(25)A/17Recordati Pharmaceuticals Limited has informed the MHRA of an error in the strength of the product printed on some of the faces (sides) of the product carton. The error is limited to one batch of Lercanidipine HCl 20mg Table…tag:www.gov.uk,2005:/drug-device-alerts/class-2-medicines-recall-synalar-gel-30g-synalar-gel-60g-fluocinoline-acetonide-0-dot-025-percent-reig-jofre-uk-el-25-a-slash-162025-04-08T12:58:22+01:00Class 2 Medicines Recall: Synalar GEL 30g, Synalar GEL 60g,(fluocinolone acetonide 0.025%) Reig Jofre UK,EL(25)A/16It has been identified that the batches of Synalar Gel 30g and 60g listed in this notification contain a residual solvent (benzene) at a level exceeding the ICH limit of 2ppm. Reig Jofre UK are recalling the batches as a pre…tag:www.gov.uk,2005:/drug-device-alerts/class-4-medicines-defect-notification-renacet-475-mg-and-950-mg-tablets-calcium-acetate-renacare-nephromed-gmbh-el-25-a152025-04-07T14:23:59+01:00Class 4 Medicines Defect Notification: Renacet 475 mg and 950 mg Tablets (calcium acetate), RenaCare NephroMed GmbH, EL(25)A15RenaCare NephroMed GmbH has informed the MHRA of the presence of an undeclared excipient in the coating of the tablets. This excipient is Macrogol 6000, which has always been included in Renacet Tablets but has been omitted …tag:www.gov.uk,2005:/drug-device-alerts/class-3-medicines-recall-urospir-50mg-slash-5ml-oral-solution-el-25-a-slash-142025-04-02T14:01:02+01:00Class 3 Medicines Recall: Urospir 50mg/5ml Oral Solution, EL(25)A/14Rosemont Pharmaceuticals Limited is recalling a single batch of Urospir 50mg/5ml Oral Solution (spironolactone) as a precautionary measure. The recall is due to errors in some of the dose calculation in millilitres being sta…tag:www.gov.uk,2005:/drug-device-alerts/class-2-medicines-recall-utrogestan-vaginal-200-mg-capsules-progesterone-el-25-a-slash-132025-04-01T10:58:54+01:00Class 2 Medicines Recall: Utrogestan Vaginal 200 mg Capsules (progesterone), EL(25)A/13Uni Health Distribution Ltd has informed the MHRA of a typographical error on the approved carton overlabel for certain batches of Utrogestan Vaginal 200 mg Capsules. The carton label references ‘micrograms’ where it should …tag:www.gov.uk,2005:/drug-device-alerts/class-2-medicines-recall-boots-paracetamol-500-mg-tablets-16s-el-25-a-slash-102025-03-04T14:35:01+00:00Class 2 Medicines Recall: Boots Paracetamol 500 mg tablets (16s), EL(25)A/10Aspar Pharmaceuticals Limited have informed the MHRA of an error related to a batch of Boots Paracetamol 500 mg tablets (16s). The foil blister inside the carton incorrectly states ‘Aspirin 300 mg Dispersible Tablets’. The t…tag:www.gov.uk,2005:/drug-device-alerts/class-2-medicines-recall-sun-pharmaceutical-industries-europe-b-dot-v-pemetrexed-1000mg-slash-100ml-10mg-slash-ml-and-800mg-slash-ml-8mg-slash-ml-infusion-bag-el-25-a-slash-092025-03-04T11:02:39+00:00Class 2 Medicines Recall: Sun Pharmaceutical Industries Europe B.V., Pemetrexed 1000MG/100ML (10mg/ml) & 800MG/100ML (8mg/ml) Infusion bag, EL(25)A/09Sun Pharmaceutical Industries Europe B.V. is recalling those product batches listed in this notification as a precautionary measure due to out of specification results reported for the Particulate Matter Test (PMT) during st…tag:www.gov.uk,2005:/drug-device-alerts/class-3-medicines-recall-azacitidine-100-mg-slash-vial-and-150-mg-slash-vial-powder-for-suspension-for-injection-el-25-a-slash-082025-03-03T11:03:15+00:00Class 3 Medicines Recall: Azacitidine 100 mg/vial and 150 mg/vial Powder for Suspension for Injection, EL(25)A/08Accord Healthcare Limited is recalling certain batches of Azacitidine Powder for Suspension for Injection 100 mg/vial and 150 mg/vial as precautionary measure due to out of specification results for Azacitidine related compo…tag:www.gov.uk,2005:/drug-device-alerts/class-3-medicines-recall-glucophage-sr-500-mg-750mg-and-1000mg-prolonged-release-tablets-el-25-a-slash-072025-02-20T14:00:20+00:00Class 3 Medicines Recall: Glucophage SR 500 mg, 750mg and 1000mg Prolonged-release Tablets, EL(25)A/07All batches of the named products are being recalled by the Marketing Authorisation Holder in Italy and subsequent UK parallel distributor companies as a precautionary measure due to the product being manufactured with the i…tag:www.gov.uk,2005:/drug-device-alerts/class-4-medicines-notification-lansoprazole-gastro-resistant-hard-capsules-15mg-el-25-a-slash-062025-02-11T11:00:20+00:00Class 4 Medicines Notification: Lansoprazole Gastro-resistant Hard Capsules 15mg, EL(25)A/06Teva UK Limited is reporting a minor typographical error on the carton for Lansoprazole Gastro-Resistant Hard Capsules 15mg. There are two instances where the dosage form is stated as “tablets” where it should state “gastro…tag:www.gov.uk,2005:/drug-device-alerts/class-2-medicines-recall-nitrofurantoin-cnx-therapeutics-100-mg-prolonged-release-capsules-el-25-a-slash-052025-02-05T10:00:55+00:00Class 2 Medicines Recall: Nitrofurantoin CNX Therapeutics 100 mg Prolonged-Release capsules, EL(25)A/05CNX Therapeutics is recalling the batches listed in this notification as a precautionary measure due to a small number of packs that contain an additional tablet of Nitrofurantoin. The registered product is a capsule contain…tag:www.gov.uk,2005:/drug-device-alerts/class-2-medicines-recall-bristol-laboratories-limited-amlodipine-bristol-lab-2-dot-5-mg-tablets-el-25-a-slash-042025-01-30T11:00:10+00:00Class 2 Medicines Recall: Bristol Laboratories Limited, Amlodipine Bristol Lab 2.5 mg Tablets, EL (25)A/04Bristol Laboratories Limited is recalling the batches specified in the table as a precautionary measure due to possible microbial contamination.tag:www.gov.uk,2005:/drug-device-alerts/class-2-medicines-recall-tesco-health-dry-cough-relief-200ml-asda-strong-dry-tickly-cough-200ml-almus-dry-cough-relief-and-bells-dual-action-dry-cough-el-25-a-slash-032025-01-22T13:07:22+00:00UPDATE: Class 2 Medicines Recall: Tesco Health Dry Cough Relief 200ml, Asda Strong Dry Tickly Cough 200ml, Almus Dry Cough Relief & Bells Dual Action Dry Cough, EL(25)A/03Bells Healthcare is recalling the listed batches of dextromethorphan hydrobromide BP containing products as a precautionary measure, due to foreign material detected in some bottles. tag:www.gov.uk,2005:/drug-device-alerts/class-4-medicines-notification-irbesartan-150-mg-and-300-mg-film-coated-tablets-el-25-a-slash-022025-01-13T11:01:21+00:00Class 4 Medicines Notification: Irbesartan 150 mg and 300 mg film-coated tablets, EL(25)A/02Jubilant Pharmaceuticals NV has informed the MHRA that the Patient information leaflet (PIL) in the cartons for the batches listed in this notification include an outdated PIL.tag:www.gov.uk,2005:/drug-device-alerts/class-4-medicines-notification-rabeprazole-sodium-10mg-and-20mg-gastro-resistant-tablets-el-25-a-slash-012025-01-09T11:10:43+00:00Class 4 Medicines Notification: Rabeprazole sodium 10mg and 20mg gastro-resistant tablets, EL(25)A/01Bristol Laboratories Limited has informed the MHRA that the Patient Information Leaflet (PIL) in the batches in the table for Rabeprazole sodium 10mg and 20mg gastro-resistant tablets do not contain the most up to date safet…tag:www.gov.uk,2005:/drug-device-alerts/class-4-medicines-notification-argenx-bv-vyvgart-1000-mg-solution-for-injection-el-24-a-slash-632024-12-19T11:06:52+00:00Class 4 Medicines Notification: Argenx BV, Vyvgart 1000 mg solution for injection, EL (24)A/63Argenx BV have informed MHRA that the Patient Information Leaflet (PIL) in the affected packs incorrectly contains reference to two subcutaneous injection sites. Only subcutaneous injection to the abdomen is permitted.tag:www.gov.uk,2005:/drug-device-alerts/class-2-medicines-recall-wockhardt-uk-limited-wockair-160-microgram-slash-4-dot-5-microgram-inhalation-powder-el-24-a-slash-622024-12-09T11:03:55+00:00Class 2 Medicines Recall: Wockhardt UK Limited, WockAIR 160 microgram/4.5 microgram, inhalation powder, EL(24)A/62Wockhardt UK Limited is recalling this batch as a precautionary measure following the identification of a low number of units which may have a defect in the 'top case' resulting in a dose not being able to be dispens…tag:www.gov.uk,2005:/drug-device-alerts/class-4-medicines-defect-information-brillpharma-limited-oxybutynin-hydrochloride-brillpharma-2-dot-5-mg-slash-5-ml-oral-solution-el-24-a-slash-612024-12-04T11:01:02+00:00Class 4 Medicines Defect Information: Brillpharma Limited, Oxybutynin hydrochloride Brillpharma 2.5 mg/5 ml Oral Solution, EL(24)A/61L M Manufacturing Limited has informed the MHRA that the patient information leaflet (PIL) in the cartons for the batch listed for Oxybutynin hydrochloride Brillpharma 2.5 mg/5 ml Oral Solution include an out of date PIL, da…tag:www.gov.uk,2005:/drug-device-alerts/class-4-medicines-defect-information-kent-pharma-uk-phenoxymethylpenicillin-250mg-slash-5ml-oral-solution-sugar-free-el-24-a-slash-602024-12-03T14:17:57+00:00Class 3 Medicines Recall: Kent Pharma UK, Phenoxymethylpenicillin 250mg/5ml Oral Solution Sugar Free, EL (24)A/60Kent Pharma UK is recalling a batch of phenoxymethylpenicillin 250mg/5mL oral solution sugar free due to a low phenoxymethylpenicillin assay.tag:www.gov.uk,2005:/drug-device-alerts/class-4-medicines-defect-information-rosemont-pharmaceuticals-limited-mycophenolate-mofetil-1g-slash-5ml-oral-suspension-el-24-a-slash-592024-12-02T14:00:03+00:00Class 4 Medicines Defect Information: Rosemont Pharmaceuticals Limited, Mycophenolate Mofetil 1g/5ml Oral Suspension, EL(24)A/59Rosemont Pharmaceuticals Limited has informed the MHRA that the Press-In-Bottle-Adaptor (PIBA) supplied with the batches listed above may cause the medicine to leak when attempting to withdraw a dose.tag:www.gov.uk,2005:/drug-device-alerts/class-4-medicines-defect-information-strides-pharma-uk-ltd-liothyronine-sodium-5-and-20-micrograms-tablets-el-24-a-slash-582024-11-28T11:07:36+00:00Class 4 Medicines Defect Information: Strides Pharma UK Ltd, Liothyronine Sodium 5 & 20 micrograms Tablets, EL(24)A/58Strides Pharma UK Ltd has informed MHRA of an error in the patient information leaflet (PIL) for Liothyronine Sodium 20 micrograms Tablets and Liothyronine Sodium 5 micrograms Tablets.tag:www.gov.uk,2005:/drug-device-alerts/class-4-medicines-defect-information-morningside-healthcare-limited-tramadol-hydrochloride-50-mg-capsules-and-tramadol-hydrochloride-morningside-50-mg-prolonged-release-capsules-el-24-a-slash-572024-11-27T13:59:23+00:00Class 4 Medicines Defect Information: Morningside Healthcare Limited, Tramadol Hydrochloride 50 mg capsules & Tramadol Hydrochloride Morningside 50 mg Prolonged-Release capsules, EL(24)A/57Morningside Healthcare Limited has informed the MHRA of a packaging issue identified in batch MRA2303 of Tramadol Hydrochloride Morningside 50 mg Prolonged-Release Capsules and batch MRF2301 of Tramadol Hydrochloride 50 mg C…tag:www.gov.uk,2005:/drug-device-alerts/class-3-medicines-recall-syri-limited-t-slash-a-syrimed-baclofen-10mg-slash-5ml-oral-solution-el-24-a-slash-562024-11-25T14:01:22+00:00Class 3 Medicines Recall: Syri Limited, T/A SyriMed, Baclofen 10mg/5ml Oral Solution, EL(24)A/56Syri Limited, T/A SyriMed is recalling this batch of product as a precautionary measure due to crystallisation observed over time in the oral solution. tag:www.gov.uk,2005:/drug-device-alerts/class-4-medicines-defect-information-takeda-uk-limited-entyvio-108mg-solution-for-injection-in-pre-filled-syringe-el-24-a-slash-552024-11-18T14:24:41+00:00Class 4 Medicines Defect Information: Takeda UK Limited, Entyvio 108mg solution for injection in pre-filled syringe, EL(24)A/55Takeda UK Limited has informed the MHRA that there is an error in the Patient Information Leaflet for specified batches of Entyvio 108mg pre-filled syringes. tag:www.gov.uk,2005:/drug-device-alerts/company-led-medicines-recall-leeds-trading-company-ltc-ltd-t-slash-a-ltc-healthcare-exs-delay-spray-plus-clmr-24-a-slash-012024-11-13T14:15:19+00:00Company led medicines recall: Leeds Trading Company LTC Ltd T/A LTC Healthcare, EXS Delay Spray Plus, CLMR(24)A/01LTC Healthcare has informed the MHRA that they have been selling a medicinal product containing lidocaine without authorisation from the MHRA.tag:www.gov.uk,2005:/drug-device-alerts/class-4-medicines-defect-information-viatris-uk-healthcare-ltd-omeprazole-40-mg-powder-for-solution-for-infusion-el-24-a-slash-542024-11-12T10:59:54+00:00Class 4 Medicines Defect Information: Viatris UK Healthcare Ltd, Omeprazole 40 mg Powder for solution for infusion, EL(24)A/54Generics (U.K.) Limited has informed the MHRA that the Patient Information Leaflet (PIL) packaged in specific batches of Omeprazole 40 mg Powder for solution for infusion do not contain the most up to date safety information.