tag:www.gov.uk,2005:/drug-device-alertsAlerts, recalls and safety information: medicines and medical devices2026-05-14T10:59:11+01:00HM Governmenttag:www.gov.uk,2005:/drug-device-alerts/class-4-medicines-defect-notification-fresenius-medical-care-deutschland-gmbh-balance-2-dot-3-percent-glucose-1-dot-25-mmol-slash-l-calcium-solution-for-peritoneal-dialysis-el-26-a-slash-242026-05-14T10:59:11+01:00Class 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/24Fresenius Medical Care Deutschland GmbH have identified an error in the Braille printed on the outer label. tag:www.gov.uk,2005:/drug-device-alerts/field-safety-notices-27-april-to-1-may-20262026-05-12T15:15:24+01:00Field Safety Notices: 27 April to 1 May 2026List of Field Safety Notices from 27 April to 1 May 2026.tag:www.gov.uk,2005:/drug-device-alerts/field-safety-notices-4-to-8-may-20262026-05-12T13:46:01+01:00Field Safety Notices: 4 to 8 May 2026List of Field Safety Notices from 4 to 8 May 2026.tag:www.gov.uk,2005:/drug-device-alerts/class-4-medicines-defect-notification-milpharm-limited-loperamide-hydrochloride-2-mg-orodispersible-tablets-el-26-a-slash-232026-05-11T11:02:32+01:00Class 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. tag:www.gov.uk,2005:/drug-device-alerts/field-safety-notices-1-may-20262026-05-06T08:54:27+01:00Field Safety Notices: 1 May 2026List of Field Safety Notices for 1 May 2026.tag:www.gov.uk,2005:/drug-device-alerts/field-safety-notices-20-to-24-april-20262026-04-30T17:08:36+01:00Field Safety Notices: 20 to 24 April 2026List of Field Safety Notices from 20 to 24 April 2026.tag: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-amarox-limited-sertraline-100mg-film-coated-tablets-el-26-a-slash-222026-04-28T11:00:11+01:00Class 2 Medicines Recall: Amarox Limited, Sertraline 100mg film-coated tablets, EL(26)A/22Amarox Limited is recalling one batch of Sertraline 100 mg film-coated tablets as a precautionary measure due to an error at the manufacturing site. tag:www.gov.uk,2005:/drug-device-alerts/class-3-medicines-recall-omega-pharma-ltd-napralief-250mg-gastro-resistant-tablets-el-26-a-slash-212026-04-24T15:22:20+01:00Class 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…tag:www.gov.uk,2005:/drug-device-alerts/field-safety-notices-13-to-17-april-20262026-04-23T16:26:18+01:00Field Safety Notices: 13 to 17 April 2026List of Field Safety Notices from 13 to 17 April 2026.tag:www.gov.uk,2005:/drug-device-alerts/class-4-medicines-defect-notification-doncaster-pharma-limited-hiprex-1g-tablets-el-26-a-slash-202026-04-22T11:00:22+01:00Class 4 Medicines Defect Notification: Doncaster Pharma Limited, Hiprex 1g tablets, EL(26)A/20Doncaster 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).tag: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/field-safety-notices-6-to-10-april-20262026-04-13T14:56:15+01:00Field Safety Notices: 6 to 10 April 2026 List of Field Safety Notices for 6 to 10 April 2026.tag:www.gov.uk,2005:/drug-device-alerts/field-safety-notices-30-march-3-april-20262026-04-08T11:13:33+01:00Field Safety Notices: 30 March - 3 April 2026 List of Field Safety Notices for 30 March - 3 April 2026 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/field-safety-notices-23-27-march-20262026-03-31T09:07:32+01:00Field Safety Notices: 23-27 March 2026List of field Safety Notices for 23-27 March 2026tag:www.gov.uk,2005:/drug-device-alerts/class-2-medicines-recall-bio-products-laboratory-limited-rabies-human-normal-immunoglobulin-500iu-solution-for-injection-el-26-a-slash-182026-03-30T10:16:08+01:00Class 2 Medicines Recall: Bio Products Laboratory Limited, Rabies, Human normal Immunoglobulin 500IU solution for Injection, EL(26)A/18Bio Products Laboratory Limited is recalling one batch of Human Rabies Immunoglobulin following a stability failure for this batch. The batch has shown a reduction in potency of the Human Rabies immunoglobulin. tag:www.gov.uk,2005:/drug-device-alerts/class-4-medicines-defect-notification-sandoz-limited-apixaban-2-dot-5mg-and-5mg-tablets-el-26-a-slash-172026-03-26T14:01:58+00:00Class 4 Medicines Defect Notification: Sandoz Limited, Apixaban 2.5mg and 5mg Tablets, EL(26)A/17Sandoz Ltd. have informed the MHRA that the Patient Information Leaflet included in specified batches of Apixaban does not contain up‑to‑date information. tag:www.gov.uk,2005:/drug-device-alerts/class-4-medicines-defect-notification-quadrant-pharmaceuticals-limited-vesomni-6-mg-slash-0-dot-4-mg-modified-release-tablets-el-26-a-slash-162026-03-26T10:02:07+00:00Class 4 Medicines Defect Notification: Quadrant Pharmaceuticals Limited, Vesomni 6 mg/0.4 mg modified release tablets , EL(26)A/16Quadrant Pharmaceuticals Limited have informed the MHRA that their parallel imported packs of Vesomni 6 mg/0.4 mg modified release tablets have been printed with the incorrect barcode/GTIN on the carton. tag:www.gov.uk,2005:/drug-device-alerts/field-safety-notices-16-20-march-20262026-03-24T09:08:38+00:00Field Safety Notices: 16 - 20 March 2026 List of Field Safety Notices for 16 - 20 March 2026 tag: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/field-safety-notices-9-13-march-20262026-03-20T14:43:34+00:00Field Safety Notices: 9 - 13 March 2026 A list of Field Safety Notice for 9 - 13 March 2026 tag:www.gov.uk,2005:/drug-device-alerts/class-4-medicines-defect-notification-baxter-healthcare-corporation-onkotrone-injection-2-mg-slash-ml-concentrate-for-solution-for-infusion-el-26-a-slash-142026-03-17T11:00:03+00:00Class 4 Medicines Defect Notification: Baxter Healthcare Corporation, Onkotrone Injection 2 mg/ml concentrate for solution for infusion, EL(26)A/14Baxter Healthcare Corporation have informed the MHRA that the Patient Information Leaflet (PIL) packed in specified batches does not contain up to date information relating to the duration of contraception required for femal…tag:www.gov.uk,2005:/drug-device-alerts/class-2-medicines-recall-rokshaw-limited-trading-as-curaleaf-laboratories-curaleaf-oil-fs-10mg-slash-ml-thc-10mg-slash-ml-cbd-30ml-el-26-a-slash-132026-03-12T14:12:08+00:00Class 2 Medicines Recall: Rokshaw Limited Trading as Curaleaf Laboratories, Curaleaf Oil [FS] 10mg/ml THC, 10mg/ml CBD (30ml), EL(26)A/13Curaleaf Laboratories are recalling three batches of Curaleaf Oil [FS] 10mg/ml THC 10mg/ml CBD (30ml) due to low THC content.
tag:www.gov.uk,2005:/drug-device-alerts/class-3-medicines-recall-bayer-plc-various-products-el-26-a-slash-122026-03-12T11:00:01+00:00Class 3 Medicines Recall: Bayer Plc, Various Products, EL(26)A/12Bayer Plc is recalling all stock of the products listed in this notification as a precautionary measure due to the identification of an impurity above the acceptable limit. The recall is at pharmacy and wholesaler level.tag:www.gov.uk,2005:/drug-device-alerts/field-safety-notices-02-to-06-march-20262026-03-09T16:01:47+00:00Field Safety Notices: 02 to 06 March 2026List of Field Safety Notices from 2 March to 6 March 2026.tag:www.gov.uk,2005:/drug-device-alerts/class-2-medicines-recall-crescent-pharma-limited-ramipril-5mg-capsules-el-26-a-slash-112026-03-06T15:27:24+00:00Class 2 Medicines Recall: Crescent Pharma Limited, Ramipril 5mg capsules, EL(26)A/11Crescent Pharma Limited is recalling one batch of Ramipril 5 mg Capsules as a precautionary measure due to a potential error at the manufacturing site. tag:www.gov.uk,2005:/drug-device-alerts/field-safety-notices-23-27-february-20262026-03-03T10:42:25+00:00Field Safety Notices: 23-27 February 2026 List of Field Safety Notices from 23-27 February 2026.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/class-4-medicines-defect-notification-rayner-pharmaceuticals-limited-dropodex-0-dot-1-percent-w-slash-v-eye-drops-solution-el-26-a-slash-102026-02-24T13:04:42+00:00Class 4 Medicines Defect Notification: Rayner Pharmaceuticals Limited, Dropodex 0.1% w/v Eye Drops, solution, EL(26)A/10Rayner Pharmaceuticals limited have informed the MHRA that the batches listed in this notification do not include the concentration of phosphates in the product information.tag:www.gov.uk,2005:/drug-device-alerts/field-safety-notices-16-20-february-20262026-02-24T11:11:30+00:00Field Safety Notices: 16-20 February 2026List of Field Safety Notices: 16-20 February 2026tag:www.gov.uk,2005:/drug-device-alerts/class-2-medicines-recall-sterling-pharmaceuticals-ltd-specials-manufacturer-ms-32515-kidnaps-melatonin-1mg-in-1ml-oral-solution-el-26-a-slash-092026-02-23T10:00:32+00:00Class 2 Medicines Recall: Sterling Pharmaceuticals Ltd (specials manufacturer MS 32515), KidNaps (Melatonin) 1mg in 1ml Oral Solution, EL(26)A/09Sterling Pharmaceuticals Ltd and Veriton Pharma Ltd are recalling all batches of KidNaps (Melatonin) 1mg in 1ml Oral Solution due to out of specification stability results. tag:www.gov.uk,2005:/drug-device-alerts/field-safety-notices-09-13-february-20262026-02-17T14:02:12+00:00Field Safety Notices: 09-13 February 2026A list of Field Safety Notices: 09-13 February 2026tag:www.gov.uk,2005:/drug-device-alerts/class-3-medicines-recall-norgine-limited-movicol-ease-citrus-powder-for-oral-solution-13-dot-7-g-el-26-a-slash-082026-02-17T10:00:42+00:00Class 3 Medicines Recall: Norgine Limited, MOVICOL Ease Citrus Powder for oral solution 13.7 g, EL(26)A/08Norgine Limited is recalling one batch of product as a precautionary measure due to some units containing low amounts of active ingredients.tag:www.gov.uk,2005:/drug-device-alerts/field-safety-notices-02-06-february-20262026-02-10T10:48:08+00:00Field Safety Notices: 02-06 February 2026List of Field Safety Notices: 02-06 February 2026tag:www.gov.uk,2005:/drug-device-alerts/class-3-medicines-recall-aspar-pharmaceuticals-ltd-ibuprofen-200mg-tablets-ibucalm-200mg-tablets-el-26-a-slash-072026-02-04T14:00:44+00:00Class 3 Medicines Recall: Aspar Pharmaceuticals Ltd, Ibuprofen 200mg Tablets, Ibucalm 200mg tablets, EL(26)A/07Aspar Pharmaceuticals Ltd is recalling specific batches distributed in Aspar, Almus and Numark livery. The batches are being recalled as a precautionary measure following findings of foil perforations in some blisters.tag:www.gov.uk,2005:/drug-device-alerts/class-2-medicines-recall-syri-limited-t-slash-a-syrimed-baclofen-10mg-slash-5ml-oral-solution-el-26-a-slash-062026-02-03T11:55:55+00:00Class 2 Medicines Recall: Syri Limited, T/A SyriMed, Baclofen 10mg/5ml Oral Solution, EL(26)A/06Syri Limited, T/A SyriMed is recalling batches of product as a precautionary measure due to crystallisation observed over time in the oral solution. tag:www.gov.uk,2005:/drug-device-alerts/field-safety-notices-26-30-january-20262026-02-02T15:37:23+00:00Field Safety Notices: 26 to 30 January 2026List of Field Safety Notices from 26 to 30 January 2026.tag:www.gov.uk,2005:/drug-device-alerts/class-2-medicines-recall-accord-healthcare-ltd-carmustine-100-mg-powder-and-solvent-for-concentrate-for-solution-for-infusion-1-vial-100mg-powder-1-vial-of-3-ml-solvent-el-26-a-slash-052026-02-02T11:00:19+00:00Class 2 Medicines Recall: Accord Healthcare Ltd, Carmustine 100 mg Powder and Solvent for Concentrate for Solution for Infusion (1 vial 100mg powder, 1 vial of 3 mL solvent), EL(26)A/05Accord Healthcare limited is recalling a single batch due to an out of specification test result.tag: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/class-4-medicines-defect-notification-viatris-products-ltd-arixtra-solution-for-injection-pre-filled-syringes-el-26-a-slash-042026-01-28T11:00:06+00:00Class 4 Medicines Defect Notification: Viatris Products Ltd, Arixtra solution for injection, pre-filled syringes, EL(26)A/04Viatris has received reports of brown discolouration and blockage in the needle of pre-filled syringes of Arixtra. This quality defect is related to oxidation of the syringe needle.
tag:www.gov.uk,2005:/drug-device-alerts/field-safety-notices-19-to-23-january-20262026-01-27T15:21:38+00:00Field Safety Notices: 19 to 23 January 2026List of Field Safety Notices from 19 to 23 January 2026.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/class-4-medicines-defect-notification-blumont-pharma-limited-ocumont-eye-ointment-1-percent-w-slash-w-el-26-a-slash-032026-01-27T11:00:38+00:00Class 4 Medicines Defect Notification: Blumont Pharma Limited, Ocumont Eye Ointment 1% w/w, EL(26)A/03Blumont Pharma Limited is reporting to the MHRA regarding the absence of Braille on the outer carton of one batch of Ocumont Eye Ointment 1% w/w (POM). It was identified that the Braille information was inadvertently omitted…tag:www.gov.uk,2005:/drug-device-alerts/field-safety-notices-12-to-16-january-20262026-01-22T13:52:45+00:00Field Safety Notices: 12 to 16 January 2026List of Field Safety Notices from 12 to 16 January 2026.tag:www.gov.uk,2005:/drug-device-alerts/class-3-medicines-recall-glenmark-pharmaceuticals-europe-limited-fingolimod-glenmark-0-dot-5-mg-hard-capsules-el-26-a-slash-022026-01-21T11:00:19+00:00Class 3 Medicines Recall: Glenmark Pharmaceuticals Europe Limited, Fingolimod Glenmark 0.5 mg Hard Capsules, EL(26)A/02Glenmark Pharmaceuticals Europe Limited is recalling one batch after stability testing showed out-of-specification results. The batch is being recalled as a precautionary measure following test results that showed a delay in…tag:www.gov.uk,2005:/drug-device-alerts/class-2-medicines-recall-mercury-pharmaceuticals-ltd-paliperidone-mercury-pharma-prolonged-release-suspension-for-injection-in-pre-filled-syringes-el-26-a-slash-012026-01-20T13:15:13+00:00Class 2 Medicines Recall: Mercury Pharmaceuticals Ltd, Paliperidone Mercury Pharma prolonged-release suspension for injection in pre-filled syringes, EL(26)A/01Mercury Pharmaceuticals Ltd is recalling remaining stock of paliperidone pre-filled syringes as a precautionary measure due to Good Manufacturing Practice (GMP) deficiencies cited during a recent inspection at the finished p…tag: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/field-safety-notices-for-05-09-january-20262026-01-12T16:59:18+00:00Field Safety Notices for 05-09 January 2026List of Field Safety Notices for 05-09 January 2026tag:www.gov.uk,2005:/drug-device-alerts/field-safety-notices-29-december-2025-to-2-january-20262026-01-07T09:19:39+00:00Field Safety Notices: 29 December 2025 to 2 January 2026 List of Field Safety Notices from 29 December 2025 to 2 January 2026.