tag:www.gov.uk,2005:/drug-device-alertsAlerts, recalls and safety information: medicines and medical devices2025-04-29T13:59:27+01:00HM Governmenttag: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/field-safety-notices-21-to-25-april-20252025-04-29T12:02:02+01:00Field Safety Notices: 21 to 25 April 2025List of Field Safety Notices from 21 to 25 April 2025.tag:www.gov.uk,2005:/drug-device-alerts/class-4-medicines-defect-notification-pregabalin-25mg-50mg-75mg-100mg-150mg-200mg-225mg-300mg-capsules-jubilant-pharmaceuticals-nv-el-25-a-slash-192025-04-29T11:01:44+01:00Class 4 Medicines Defect Notification: Pregabalin 25mg, 50mg, 75mg, 100mg, 150mg, 200mg, 225mg, 300mg Capsules, Jubilant Pharmaceuticals NV, EL(25)A/19Jubilant Pharmaceuticals BV has informed the MHRA that the outer carton (box) of the product batches mentioned in this notification are missing the medicines legal classification for a Prescription Only Medicine ‘POM�. There�tag:www.gov.uk,2005:/drug-device-alerts/field-safety-notices-14-to-18-april-20252025-04-25T09:35:42+01:00Field Safety Notices: 14 to 18 April 2025List of Field Safety Notices from 14 to 18 April 2025.tag:www.gov.uk,2005:/drug-device-alerts/class-4-medicines-defect-notification-brilique-90mg-tablets-el-25-a-slash-182025-04-24T11:01:57+01:00Class 4 Medicines Defect Notification: Brilique 90mg Tablets, EL(25)A/18G Pharma Ltd have informed the MHRA that there is an error in the spelling of the active ingredient included on the imported carton. The spelling should be ‘Ticagrelor� but has been printed as ‘Tricagelor� under the brand na�tag: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/field-safety-notices-7-to-11-april-20252025-04-15T14:38:51+01:00Field Safety Notices: 7 to 11 April 2025List of Field Safety Notices from 7 to 11 April 2025tag:www.gov.uk,2005:/drug-device-alerts/mhra-safety-roundup-march-20252025-04-08T17:53:02+01:00MHRA Safety Roundup: March 2025Summary of the latest safety advice for medicines and medical device userstag: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/field-safety-notices-31-march-to-4-april-20252025-04-08T08:49:18+01:00Field Safety Notices: 31 March to 4 April 2025List of Field Safety Notices from 31 March to 4 April 2025.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/field-safety-notices-24-to-28-march-20252025-04-01T11:08:20+01:00Field Safety Notices: 24 to 28 March 2025List of Field Safety Notices from 24 to 28 March 2025.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-4-medicines-defect-notification-sirdupla-25-microgram-slash-250-microgram-per-metered-dose-pressurised-inhalation-suspension-el-25-a-slash-122025-03-31T11:04:37+01:00Class 4 Medicines Defect Notification: Sirdupla 25 microgram/250 microgram per metered dose pressurised inhalation, suspension, EL(25)A/12Cross Healthcare Limited have informed the MHRA that there is a printing defect on the outer labels for the Sirdupla 25 microgram/250 microgram per metered dose pressurised inhalation, suspension, batch 77518. tag:www.gov.uk,2005:/drug-device-alerts/field-safety-notices-17-to-21-march-20252025-03-26T13:44:31+00:00Field Safety Notices: 17 to 21 March 2025List of Field Safety Notices for 17 to 21 March 2025.tag:www.gov.uk,2005:/drug-device-alerts/suzhou-surgicare-disposable-hysteroscopy-sheath-recall-due-to-withdrawn-ce-certificate-dsi-slash-2025-slash-0012025-03-19T13:41:31+00:00Suzhou Surgicare disposable Hysteroscopy Sheath� Recall due to withdrawn CE certificate, (DSI/2025/001)The MHRA has become aware of Hysteroscopy Sheaths supplied in the UK market with a withdrawn CE certificate. Healthcare professionals and providers should immediately stop use, quarantine, and stop supply of any identified p�tag:www.gov.uk,2005:/drug-device-alerts/field-safety-notices-10-to-14-march-20252025-03-19T11:02:47+00:00Field Safety Notices: 10 to 14 March 2025List of Field Safety Notices from 10 to 14 March 2025.tag:www.gov.uk,2005:/drug-device-alerts/class-4-medicines-defect-notification-azithromycin-250-mg-capsules-el-25-a-slash-112025-03-12T15:28:41+00:00UPDATE: Class 4 Medicines Defect Notification: Azithromycin 250 mg Capsules, EL(25)A/11Jubilant Pharmaceuticals NV has informed the MHRA that the Patient information leaflet (PIL) in the cartons for the batches listed is outdated.tag:www.gov.uk,2005:/drug-device-alerts/field-safety-notices-3-to-7-march-20252025-03-11T10:59:15+00:00Field Safety Notices: 3 to 7 March 2025List of Field Safety Notices from 3 to 7 March 2025.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/field-safety-notices-24-to-28-february-20252025-03-04T10:02:00+00:00Field Safety Notices: 24 to 28 February 2025List of Field Safety Notices from 24 to 28 February 2025.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/field-safety-notices-17-to-21-february-20252025-02-25T10:18:45+00:00Field Safety Notices: 17 to 21 February 2025List of Field Safety Notices from 17 to 21 February 2025.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/field-safety-notices-10th-14th-february-20252025-02-14T17:11:29+00:00Field Safety Notices: 10 to 14 February 2025List of Field Safety Notices from 10 to 14 February 2025.tag:www.gov.uk,2005:/drug-device-alerts/field-safety-notices-3-to-7-february-20252025-02-12T10:06:47+00:00Field Safety Notices: 3 to 7 February 2025List of Field Safety Notices from 3 to 7 February 2025.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/field-safety-notices-27-to-31-january-20252025-02-04T09:53:20+00:00Field Safety Notices: 27 to 31 January 2025List of Field Safety Notices from 27 to 31 January 2025.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/field-safety-notices-23-to-27-december-20242025-01-29T13:28:24+00:00Field Safety Notices: 23 to 27 December 2024List of Field Safety Notices from 23 to 27 December 2024tag:www.gov.uk,2005:/drug-device-alerts/field-safety-notices-20-to-24-january-20252025-01-29T13:26:13+00:00Field Safety Notices: 20 to 24 January 2025List of Field Safety Notices from 20 to 24 January 2025.tag:www.gov.uk,2005:/drug-device-alerts/field-safety-notices-13-to-17-january-20252025-01-22T17:21:07+00:00Field Safety Notices: 13 to 17 January 2025List of Field Safety Notices from 13 to 17 January 2025.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/field-safety-notices-21-to-25-august-20232025-01-16T12:51:33+00:00Field Safety Notices: 21 to 25 August 2023List of Field Safety Notices from 21 to 25 August 2023tag:www.gov.uk,2005:/drug-device-alerts/field-safety-notices-19-to-23-june-20232025-01-16T12:32:42+00:00Field Safety Notices: 19 to 23 June 2023List of Field Safety Notices from 19 to 23 June 2023tag:www.gov.uk,2005:/drug-device-alerts/field-safety-notices-6-to-10-january-20252025-01-14T09:16:44+00:00Field Safety Notices: 6 to 10 January 2025List of Field Safety Notices from 6 to 10 January 2025.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/field-safety-notices-30-december-2024-to-3-january-20252025-01-07T09:17:26+00:00Field Safety Notices: 30 December 2024 to 3 January 2025List of Field Safety Notices from 30 December 2024 to 3 January 2025.tag:www.gov.uk,2005:/drug-device-alerts/field-safety-notices-16-to-20-december-20242024-12-24T13:08:30+00:00Field Safety Notices: 16 to 20 December 2024List of Field Safety Notices from 16 to 20 December 2024.tag:www.gov.uk,2005:/drug-device-alerts/field-safety-notices-20-december-20242024-12-20T16:35:23+00:00Field Safety Notices: 20 December 2024List of Field Safety Notice for 20 December 2024.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/field-safety-notices-9-to-13-december-20242024-12-17T11:41:03+00:00Field Safety Notices: 9 to 13 December 2024List of Field Safety Notices from 9 to 13 December 2024.tag:www.gov.uk,2005:/drug-device-alerts/field-safety-notices-2-to-6-december-20242024-12-10T09:03:35+00:00Field Safety Notices: 2 to 6 December 2024List of Field Safety Notices from 2 to 6 December 2024.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/field-safety-notices-25-to-29-november-20242024-12-05T09:41:28+00:00Field Safety Notices: 25 to 29 November 2024List of Field Safety Notices from 25 to 29 November 2024.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�