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, 19:00.
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 2 of 3. Showing the community pharmacy view.
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RecallClass 2 · Action within 48 hours
Class 2 Medicines Recall: Crescent Pharma Limited, Ramipril 10mg capsules, EL(26)A/19
Crescent Pharma Limited is recalling one batch of Ramipril 10mg Capsules as a precautionary measure due to a potential error at the manufacturing site.
GOV.UK notice Every medicines recall is shown.
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RecallClass 2 · Action within 48 hours
Class 2 Medicines Recall: Bio Products Laboratory Limited, Rabies, Human normal Immunoglobulin 500IU solution for Injection, EL(26)A/18
Bio 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.
GOV.UK notice Every medicines recall is shown.
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RecallClass 4 · Caution in use
Class 4 Medicines Defect Notification: Sandoz Limited, Apixaban 2.5mg and 5mg Tablets, EL(26)A/17
Sandoz Ltd. have informed the MHRA that the Patient Information Leaflet included in specified batches of Apixaban does not contain up‑to‑date information.
GOV.UK notice Every medicines recall is shown.
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RecallClass 4 · Caution in use
Class 4 Medicines Defect Notification: Quadrant Pharmaceuticals Limited, Vesomni 6 mg/0.4 mg modified release tablets , EL(26)A/16
Quadrant 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.
GOV.UK notice Every medicines recall is shown.
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RecallClass 2 · Action within 48 hours
Class 2 Medicines Recall: Regent Medical Limited / Mölnlycke Health Care, Hibiwash 500ml, EL(26)A/15
Mölnlycke Health Care are recalling specific batches of Hibiwash due to microbial contamination at the manufacturing facility, following routine weekly microbiological monitoring.
GOV.UK notice Every medicines recall is shown.
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RecallClass 4 · Caution in use
Class 4 Medicines Defect Notification: Baxter Healthcare Corporation, Onkotrone Injection 2 mg/ml concentrate for solution for infusion, EL(26)A/14
Baxter 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 females after stopping taking this medication.
GOV.UK notice Every medicines recall is shown.
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RecallClass 2 · Action within 48 hours
Class 2 Medicines Recall: Rokshaw Limited Trading as Curaleaf Laboratories, Curaleaf Oil [FS] 10mg/ml THC, 10mg/ml CBD (30ml), EL(26)A/13
Curaleaf Laboratories are recalling three batches of Curaleaf Oil [FS] 10mg/ml THC 10mg/ml CBD (30ml) due to low THC content.
GOV.UK notice Every medicines recall is shown.
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RecallClass 3 · Action within 5 days
Class 3 Medicines Recall: Bayer Plc, Various Products, EL(26)A/12
Bayer 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.
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 5mg capsules, EL(26)A/11
Crescent Pharma Limited is recalling one batch of Ramipril 5 mg Capsules as a precautionary measure due to a potential error at the manufacturing site.
GOV.UK notice Every medicines recall is shown.
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RecallClass 2 · Action within 48 hours
Class 2 Medicines Recall: Sterling Pharmaceuticals Ltd (specials manufacturer MS 32515), KidNaps (Melatonin) 1mg in 1ml Oral Solution, EL(26)A/09
Sterling 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.
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 Ease Citrus Powder for oral solution 13.7 g, EL(26)A/08
Norgine Limited is recalling one batch of product as a precautionary measure due to some units containing low amounts of active ingredients.
GOV.UK notice Every medicines recall is shown.
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RecallClass 3 · Action within 5 days
Class 3 Medicines Recall: Aspar Pharmaceuticals Ltd, Ibuprofen 200mg Tablets, Ibucalm 200mg tablets, EL(26)A/07
Aspar 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.
GOV.UK notice Every medicines recall is shown.
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RecallClass 2 · Action within 48 hours
Class 2 Medicines Recall: Syri Limited, T/A SyriMed, Baclofen 10mg/5ml Oral Solution, EL(26)A/06
Syri Limited, T/A SyriMed is recalling batches of product as a precautionary measure due to crystallisation observed over time in the oral solution.
GOV.UK notice Every medicines recall is shown.
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RecallClass 2 · Action within 48 hours
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/05
Accord Healthcare limited is recalling a single batch due to an out of specification test result.
GOV.UK notice Every medicines recall is shown.
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RecallClass 4 · Caution in use
Class 4 Medicines Defect Notification: Viatris Products Ltd, Arixtra solution for injection, pre-filled syringes, EL(26)A/04
Viatris 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.
GOV.UK notice Every medicines recall is shown.
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RecallClass 4 · Caution in use
Class 4 Medicines Defect Notification: Blumont Pharma Limited, Ocumont Eye Ointment 1% w/w, EL(26)A/03
Blumont 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 during the approval and release process.
GOV.UK notice Every medicines recall is shown.
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RecallClass 3 · Action within 5 days
Class 3 Medicines Recall: Glenmark Pharmaceuticals Europe Limited, Fingolimod Glenmark 0.5 mg Hard Capsules, EL(26)A/02
Glenmark 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 capsule dissolution.
GOV.UK notice Every medicines recall is shown.
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RecallClass 2 · Action within 48 hours
Class 2 Medicines Recall: Mercury Pharmaceuticals Ltd, Paliperidone Mercury Pharma prolonged-release suspension for injection in pre-filled syringes, EL(26)A/01
Mercury 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 product manufacturing site.
GOV.UK notice Every medicines recall is shown.
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RecallClass 3 · Action within 5 days
Class 3 Medicines Recall: Activase Pharmaceuticals Limited, Prednisolone 5mg Soluble Tablets, EL(25)A/54
Activase Pharmaceuticals Limited is recalling two batches of Prednisolone 5mg Soluble Tablets as a precautionary measure due to a limited number of reports of blister pockets becoming swollen over time.
GOV.UK notice Every medicines recall is shown.
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RecallClass 2 · Action within 48 hours
Class 2 Medicines Recall: Hameln Pharma Ltd, Clarithromycin 500 mg powder for concentrate for solution for infusion, EL(25)A/53
Hameln Pharma Ltd is recalling certain batches of Clarithromycin 500 mg powder for concentrate 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: Flamingo Pharma UK Ltd, Amitriptyline Hydrochloride 10mg, 25mg, 50mg Tablets, EL(25)A/52
Flamingo Pharma UK Ltd has informed the MHRA that the Patient Information Leaflet (PIL) in the products listed in this notification do not contain all the required safety information.
GOV.UK notice Every medicines recall is shown.
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RecallClass 4 · Caution in use
Class 4 Medicines Defect Notification: Special Concept Development UK Limited, Baclofen 10mg Tablets, EL(25)A/51
Special Concept Development UK Limited has informed the MHRA that the Patient Information Leaflet (PIL) for the batches listed in this notification do not contain the correct safety information.
GOV.UK notice Every medicines recall is shown.
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RecallClass 4 · Caution in use
Class 4 Medicines Defect Notification: Lexon UK Ltd, Moclobemide 150mg tablets, EL(25)A/50
Lexon UK Ltd has informed the MHRA that the Patient Information Leaflet (PIL) in the cartons for the batches listed in this notification is missing important updated safety information.
GOV.UK notice Every medicines recall is shown.
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RecallClass 3 · Action within 5 days
Class 3 Medicines Recall: Sun Pharmaceutical Industries Limited, Fingolimod SUN 0.5mg hard capsules, EL(25)A/49
Sun Pharma UK Limited is conducting a precautionary recall of a single batch of Fingolimod SUN 0.5 mg hard capsules due to reports of capsule breakage on removing from the blister. No other batches of Fingolimod SUN 0.5mg hard capsules are impacted.
GOV.UK notice Every medicines recall is shown.
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RecallClass 3 · Action within 5 days
Class 3 Medicines Recall: Sun Pharmaceutical Industries Limited, Atorvastatin 20mg and 80mg Film-coated Tablets, EL(25)A/48
Sun Pharma UK Limited are recalling the batches of tablets specified in the table as a precautionary measure due to failing dissolution test results reported during ongoing stability studies.
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.