Class 3 recall-Prednisolone 5mg soluble tabs

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.

MHRA drug alert link https://www.gov.uk/drug-device-alerts/class-3-medicines-recall-activase-pharmaceuticals-limited-prednisolone-5mg-soluble-tablets-el-25-a-slash-54?utm_medium=email&utm_campaign=govuk-notifications-topic&utm_source=1366bdc1-73bc-4d3f-b72b-aa21c0cdac67&utm_content=immediately

MHRA drug alert date 15/12/25

Further Information

For all medical information enquiries and information on this product, please email eupvg@genreg.eu or telephone 020 72010421.

For stock control enquiries please email info@genesis-pharma.com or telephone 0207 2010400.

Please return all affected stock to your original supplier for credit. Unfortunately we can only accept stock purchased from us (Alliance Healthcare Distribution Limited). Any other stock will be returned to your stores/Pharmacies.

Please note that anything not returned to us, or notified to us, within 3 months of this notification, cannot be reimbursed by way of a credit.

Class 2 recall-Pharma Ltd, Clarithromycin 500 mg powder for concentrate for solution for infusion

Hameln Pharma Ltd is recalling the batches of Clarithromycin 500 mg powder for concentrate for solution for infusion listed in the table. Following an inspection of the clarithromycin lactobionate raw material manufacturer, the certification of suitability for use in medicines was withdrawn due to non-compliance with Good Manufacturing Practice.

MHRA drug alert link https://www.gov.uk/drug-device-alerts/class-2-medicines-recall-hameln-pharma-ltd-clarithromycin-500-mg-powder-for-concentrate-for-solution-for-infusion-el-25-a-slash-53?utm_medium=email&utm_campaign=govuk-notifications-topic&utm_source=a7aee035-dcbb-4a49-acb7-05dc0d52d0d7&utm_content=immediately

MHRA drug alert date: 11/12/25

Further Information

For all medical information enquiries and information on this product, please email drug.safety@hameln-pharma.co.uk or telephone +44 (0)1452 621 661.

For stock control enquiries please email customer.services@hameln-pharma.co.uk , or telephone +44 (0)1452 621 661.

Please return all affected stock to your original supplier for credit. Unfortunately we can only accept stock purchased from us (Alliance Healthcare Distribution Limited). Any other stock will be returned to your stores/Pharmacies.

Please note that anything not returned to us, or notified to us, within 3 months of this notification, cannot be reimbursed by way of a credit.

Class 4 Caution In Use-Amitriptyline Hydrochloride 10mg, 25mg, 50mg Tablets Flamingo Pharma

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.

MHRA drug alert Date: 10/12/25

MHRA drug alert link Class 4 Medicines Defect Notification: Flamingo Pharma UK Ltd, Amitriptyline Hydrochloride 10mg, 25mg, 50mg Tablets, EL(25)A/52 - GOV.UK

This is a caution in use only we are not accepting stock returns

further information

For all medical information enquiries and information on this product, please email safety@flamingopharma.co.uk , or telephone +44 (0) 800 0668 348.

For stock control enquiries please email sales@flamingopharma.co.uk , or telephone +44 (0) 7784 240228.

Field safety notice-Stomahesive seal 48mm

This communication is to inform customers that Convatec is issuing a voluntary Field Correction Notice due to a
formatting discrepancy identified in the UDI barcode printed on the packaging of the products listed.

The barcode encoding on the secondary Market unit (sellable unit) places the Production Identifier (PI) before the
Device Identifier (DI), contrary to the expected UDI structure. This formatting may prevent the barcode from being
scanned correctly by some customer systems. The human-readable UDI text on the secondary Market unit (sellable
unit) remains accurate and complete. Note that the labelling on the products inside is also correct.

This is a caution in use only we are not accepting stock returns

further information

uk.customerservice@convatec.com

Class 4 caution in use- Baclofen 10mg Tablets, Special Concept Development UK Limited

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.

MHRA drug alert Date: 27/11/25

MHRA drug alert link:Class 4 Medicines Defect Notification: Special Concept Development UK Limited, Baclofen 10mg Tablets, EL(25)A/51 - GOV.UK

This is a caution in use only we are not accepting stock returns

further information

For medical information enquiries please email medinfo@rxfarma.co.uk or telephone 08003580163.

For supply chain inquiries please contact email supplychain@rxfarma.co.uk or telephone 01923 332 777.

Class 4 Caution in use-Moclobemide 150mg tablets

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.

MHRA drug alert Date: 25/11/25

MHRA drug alert link: Class 4 Medicines Defect Notification: Lexon UK Ltd, Moclobemide 150mg tablets, EL(25)A/50 - GOV.UK

This is a caution in use only we are not accepting stock returns

further information

For all medical information enquiries and information on this product, please email QA@lexonuk.com, or telephone 01527 505 414. For stock control enquiries please email QA@lexonuk.com, or telephone 01527 505 414.

Class 3 recall- Fingolimod SUN 0.5mg hard capsules

CLASS 3 RECALL

Class 3 Recall from Sun Pharmaceutical Industries Limited

on Fingolimod SUN 0.5mg hard capsules

MHRA drug alert link https://www.gov.uk/drug-device-alerts/class-3-medicines-recall-sun-pharmaceutical-industries-limited-fingolimod-sun-0-dot-5mg-hard-capsules-el-25-a-slash-49?utm_medium=email&utm_campaign=govuk-notifications-topic&utm_source=43ceb057-770e-45c5-b999-ad92df38ac1a&utm_content=immediately

MHRA ref: PL 31750/017

Reason: “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.”

Please can you ensure that your stores quarantine the product listed below.

Further Information

For all medical information enquiries and information on this product, please email Cserv.uk@sunpharma.com, or telephone 020 8848 5050 / 07974754551.

For stock control enquiries please email Cserv.uk@sunpharma.com, or telephone 020 8848 5050.

Please return all affected stock to your original supplier for credit. Unfortunately, we can only accept stock purchased from us (Alliance Healthcare Distribution Limited). Any other stock will be returned to your stores/Pharmacies.

Please note that anything not returned to us, or notified to us, within 3 months of this notification, cannot be reimbursed by way of a credit.

Class 3 recall-Atorvastatin 20mg and 80mg Film-coated Tablet

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.

MHRA drug alert link https://www.gov.uk/drug-device-alerts/class-3-medicines-recall-sun-pharmaceutical-industries-limited-atorvastatin-20mg-and-80mg-film-coated-tablets-el-25-a-slash-48?utm_medium=email&utm_campaign=govuk-notifications-topic&utm_source=99643300-1345-488a-afc4-eb384dcbc1d6&utm_content=immediately

MHRA drug alert date 11/11/25

Further Information

For all medical information enquiries and information on this product, please email Cserv.uk@sunpharma.com, or telephone 020 8848 5050 / 07974754551.

For stock control enquiries please email Cserv.uk@sunpharma.com, or telephone 020 8848 5050.

Please return all affected stock to your original supplier for credit. Unfortunately we can only accept stock purchased from us (Alliance Healthcare Distribution Limited). Any other stock will be returned to your stores/Pharmacies.

Please note that anything not returned to us, or notified to us, within 3 months of this notification, cannot be reimbursed by way of a credit.

Class 3 recall-Emylif 50mg orodispersible film

Zambon SpA is recalling an affected batch as a precautionary measure due to out of specification results for unknown impurities during ongoing stability testing.

MHRA drug alert link https://www.gov.uk/drug-device-alerts/class-3-medicines-recall-zambon-spa-emylif-50mg-orodispersible-film-el-25-a-slash-47

MHRA drug alert date 10/11/25

Further Information

For all medical information enquiries and information on this product, please email infoUK@zambongroup.com, or telephone + 44 (0)800 0288 942.

For stock control enquiries please email infoUK@zambongroup.com, or telephone + 44 (0)800 0288 942.

Please return all affected stock to your original supplier for credit. Unfortunately we can only accept stock purchased from us (Alliance Healthcare Distribution Limited). Any other stock will be returned to your stores/Pharmacies.

Please note that anything not returned to us, or notified to us, within 3 months of this notification, cannot be reimbursed by way of a credit.

Class 2 recall- Compound Sodium Lactate Solution for Infusion BP (Hartmann's Solution for infusion) in Viaflo 1000ml

Baxter Healthcare is recalling one batch of Compound Sodium Lactate (Hartmann’s Solution) 1000mL. This is due to a packaging error where some cartons labelled as Hartmann’s Solution may contain Ringer’s Solution 1000mL.

MHRA drug alert linkhttps://www.gov.uk/drug-device-alerts/class-2-medicines-recall-baxter-healthcare-limited-compound-sodium-lactate-solution-for-infusion-bp-hartmanns-solution-for-infusion-in-viaflo-1000ml-el-25-a-slash-46?utm_medium=email&utm_campaign=govuk-notifications-topic&utm_source=4134130c-5221-48d2-8fe8-bc296bb64f23&utm_content=immediately

MHRA drug alert date 28/10/25

Further Information

For all medical information enquiries and information on this product, please email Medinfo_UKI@baxter.com, or telephone 0800 0260514. 

For stock control enquiries please email victoria_franklin@baxter.com, or telephone +44 07825 374866. 

Please return all affected stock to your original supplier for credit. Unfortunately we can only accept stock purchased from us (Alliance Healthcare Distribution Limited). Any other stock will be returned to your stores/Pharmacies.

Please note that anything not returned to us, or notified to us, within 3 months of this notification, cannot be reimbursed by way of a credit.