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, 17:00.
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.
-
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
-
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
-
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
85 items · page 2 of 4. Showing the community pharmacy view.
-
RecallClass 2 · Action within 48 hours
Class 2 Medicines Recall: Bristol Laboratories Limited, Phenoxymethylpenicillin 250 mg/5ml Sugar free Oral Solution BP, EL(26)A/33
Bristol Laboratories Limited is recalling one batch (7124002) of Phenoxymethylpenicillin 250 mg/5 ml Oral Solution Sugar Free due to product labelling issues.
GOV.UK notice Every medicines recall is shown.
-
RecallClass 4 · Caution in use
UPDATE: Class 4 Medicines Defect Notification: Relonchem Limited, Gabapentin Relonchem 50mg/ml Oral Solution, EL(26)A/31
Relonchem Limited have informed the MHRA that particles have been observed inside some bottles of Gabapentin Relonchem Oral Solution, identified through a customer complaint.
GOV.UK notice Every medicines recall is shown.
-
Roundup
MHRA Safety Roundup: June 2026
Summary of the latest safety advice for medicines and medical device users
GOV.UK notice Every MHRA monthly roundup is shown.
-
RecallClass 3 · Action within 5 days
Class 3 Medicines Recall: Flamingo Pharma UK Ltd, Flucloxacillin Capsules BP 500mg, EL(26)A/32
Flamingo Pharma UK Ltd have informed the MHRA that certain packs of Flucloxacillin Capsules BP 500mg contain the incorrect PIL. The affected packs contain the PIL for Amoxicillin 500mg Capsules instead of the PIL for Flucloxacillin BP 500mg Capsules.
GOV.UK notice Every medicines recall is shown.
-
RecallClass 4 · Caution in use
Class 4 Medicines Defect Notification: Brancaster Pharma Limited, Benzylpenicillin benzathine 1.2 Million I.U. and 2.4 Million I.U. powder for suspension for injection, EL(26)A/30
Brancaster Pharma Limited has informed the MHRA that the Patient Information Leaflet (PIL) in the cartons for the batches listed in this notification were released with an outdated PIL.
GOV.UK notice Every medicines recall is shown.
-
Drug Safety Update
ACE-inhibitors: Be aware of the distinction between bradykinin- and histamine-mediated angioedema, as treatment strategies differ significantly
Healthcare professionals should be aware of the potential for delayed onset of angioedema and the distinction between bradykinin- and histamine-mediated cases, as treatment strategies differ significantly and bradykinin-mediated angioedema does not respond to standard treatment.
GOV.UK notice Shown because the MHRA tagged it "Pharmacy".
-
RecallClass 3 · Action within 5 days
Class 3 Medicines Recall: Orbit Pharma Limited, Cyclizine Lactate 50 mg/ml Solution for injection, EL(26)A/29
Orbit Pharma Limited is recalling a specific batch of Cyclizine Lactate 50 mg/ml Solution for injection as a precautionary measure due to Good Manufacturing Practice (GMP) deficiencies identified at the manufacturing site.
GOV.UK notice Every medicines recall is shown.
-
RecallClass 4 · Caution in use
Class 4 Medicines Defect Notification: Cadila Pharmaceuticals Limited, Mirtazapine 30mg Tablets, EL(26)A/28
Cadila Pharmaceuticals Limited has informed the MHRA of an error with the European Article Number (EAN) barcode on the cartons of a batch of Mirtazapine 30mg Film-Coated Tablets distributed in Crescent Pharma Limited livery.
GOV.UK notice Every medicines recall is shown.
-
RecallClass 4 · Caution in use
Class 4 Medicines Defect Notification: Teva UK Ltd, Ponlimsi (Denosumab) 60mg Solution for Injection in Pre-filled Syringe, EL(26)A/27
Teva UK Limited is reporting a labelling error on the carton for Ponlimsi (Denosumab) 60mg Solution for injection in Pre-filled Syringe. The carton states “For application to the skin” when the product is licensed for subcutaneous use.
GOV.UK notice Every medicines recall is shown.
-
RecallClass 2 · Action within 48 hours
Class 2 Medicines Recall: Becton Dickinson UK Ltd, ChloraPrep 2% 1mL and ChloraPrep Frepp 2% 1.5mL applicators, EL(26)A/26
Becton Dickinson UK Ltd are recalling batches of ChloraPrep 2% 1mL applicators and ChloraPrep Frepp 2% 1.5 mL applicators due to a potential breach of sterility in the packaging process.
GOV.UK notice Every medicines recall is shown.
-
RecallClass 2 · Action within 48 hours
Class 2 Medicines Recall: Crescent Pharma Limited, Ramipril 2.5 mg Capsules, EL(26)A/25
Crescent Pharma Limited is initiating a precautionary recall of one batch of Ramipril 2.5 mg Capsules following the identification of a potential packaging error at the manufacturing site.
GOV.UK notice Every medicines recall is shown.
-
Roundup
MHRA Safety Roundup: May 2026
Summary of the latest safety advice for medicines and medical device users
GOV.UK notice Every MHRA monthly roundup is shown.
-
Device safety
Allurion Gastric Balloon: Updated safety information due to the risks of gastric outlet obstruction, small bowel obstruction and gastric perforation (DSI/2026/004)
In rare instances, the Allurion Gastric Balloon has not transited through the stomach or bowel as intended, leading to complications such as gastric outlet obstruction, small bowel obstruction and gastric perforation.
GOV.UK notice Shown because the MHRA tagged it "General practice".
-
RecallClass 4 · Caution in use
Class 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/24
Fresenius Medical Care Deutschland GmbH have identified an error in the Braille printed on the outer label.
GOV.UK notice Every medicines recall is shown.
-
Drug Safety Update
Finasteride and Dutasteride – updated safety warnings for psychiatric side effects and sexual dysfunction
The MHRA has reviewed the evidence for finasteride and dutasteride and the risk of suicidal thoughts and behaviours and has recommended further measures to minimise this risk.
GOV.UK notice Shown because the MHRA tagged it "Pharmacy".
-
RecallClass 4 · Caution in use
Class 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.
GOV.UK notice Every medicines recall is shown.
-
Drug Safety Update
Nasal decongestant sprays and drops containing xylometazoline hydrochloride / oxymetazoline hydrochloride: increased risk of rebound congestion, rhinitis medicamentosa, and tachyphylaxis with overuse
There have been reports of worsening nasal congestion (rebound congestion) when the effects of nasal decongestant sprays or drops containing xylometazoline hydrochloride and oxymetazoline hydrochloride, wear off.
GOV.UK notice Shown because the MHRA tagged it "Pharmacy".
-
Roundup
MHRA Safety Roundup: April 2026
Summary of the latest safety advice for medicines and medical device users
GOV.UK notice Every MHRA monthly roundup is shown.
-
RecallClass 2 · Action within 48 hours
Class 2 Medicines Recall: Amarox Limited, Sertraline 100mg film-coated tablets, EL(26)A/22
Amarox Limited is recalling one batch of Sertraline 100 mg film-coated tablets as a precautionary measure due to an error at the manufacturing site.
GOV.UK notice Every medicines recall is shown.
-
RecallClass 3 · Action within 5 days
Class 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 Gastro-resistant tablets.
GOV.UK notice Every medicines recall is shown.
-
RecallClass 4 · Caution in use
Class 4 Medicines Defect Notification: Doncaster Pharma Limited, Hiprex 1g tablets, EL(26)A/20
Doncaster 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).
GOV.UK notice Every medicines recall is shown.
-
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.
-
Roundup
MHRA Safety Roundup: March 2026
Summary of the latest safety advice for medicines and medical device users
GOV.UK notice Every MHRA monthly roundup is shown.
-
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.
-
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.
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.