MHRA Class 2 Medicines Recall: Paliperidone Mercury Pharma prolonged-release suspension for injection in pre-filled syringes

MHRA Class 2 Medicines Recall: Paliperidone Mercury Pharma prolonged-release suspension for injection in pre-filled syringes

Drug alert number: EL(26)A/01

Date issued: 20 January 2026

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.

DMRC reference number: DMRC-37923982

Company name: Mercury Pharmaceuticals Ltd

Medicine Details

Paliperidone Mercury Pharma 50 mg prolonged-release suspension for injection in pre-filled syringe (PLGB: 12762/0671)

Active ingredient: paliperidone palmitate

SNOMED code: 41440511000001105

GTIN: 05021691003700

Affected Lot Batch Numbers:

Paliperidone Mercury Pharma 75 mg prolonged-release suspension for injection in pre-filled syringe (PLGB: 12762/0672)

Active Ingredient: paliperidone palmitate

SNOMED code: 41440711000001100

GTIN: 05021691003717

Affected Lot Batch Numbers:

Paliperidone Mercury Pharma 100 mg prolonged-release suspension for injection in pre-filled syringe (PLGB: 12762/0673)

Active Ingredient: paliperidone palmitate

SNOMED code: 41440911000001103

GTIN: 05021691003724

Affected Lot Batch Numbers:

Paliperidone Mercury Pharma 150 mg prolonged-release suspension for injection in pre-filled syringe (PLGB: 12762/0674)

Active Ingredient: paliperidone palmitate

SNOMED code: 41441111000001107

GTIN: 05021691003731

Affected Lot Batch Numbers:

Background

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. Mercury Pharmaceuticals Ltd has confirmed that due to the ongoing remedial actions at the finished product manufacturing site, there may be delays in the manufacture of future batches.

Advice for Healthcare Professionals

Stop supplying the above batches immediately. Quarantine all stock and return it to your supplier using your supplier’s approved process.

Where appropriate, healthcare professionals involved in dispensing practices (pharmacy teams, homecare teams etc), should contact patients to advise them to contact their prescriber for a review to ensure that an alternative product is available, without delaying their treatment.

Where Paliperidone Mercury Pharma prolonged-release injections are unavailable, clinicians should ensure continuity of treatment and consider appropriate alternative licensed treatment options. These may include an alternative paliperidone palmitate product, another long-acting injectable antipsychotic, or, where clinically appropriate, an oral antipsychotic (including oral paliperidone or risperidone), in line with local formularies, NICE guidance, and individual patient needs. For some patients, oral treatment may be considered as a temporary bridging option until long-acting injectable therapy can be resumed. Switching between treatments should be planned to avoid missed doses and minimise the risk of relapse, with appropriate clinical monitoring for efficacy and tolerability, particularly during the initial period following a change in treatment.

No specific safety concerns have been identified with the affected batches, and a review of the company safety database has not identified any increase in adverse events associated with this issue.

View the full alert here.

Advice for Patients

This recall is precautionary and relates to manufacturing standards rather than a confirmed problem with the medicine itself.

Patients are advised to contact their prescriber as soon as possible to arrange treatment without interruption. Patients should continue to take the medication until they have arranged alternative treatment.

Mercury Pharmaceuticals Ltd has not identified any adverse events related to this issue. A review of the company’s safety data has not identified any safety concerns associated with the affected batches. Patients who have already received injections from the affected batches do not require any additional monitoring beyond routine clinical care unless they have concerns or experience new symptoms.

Patients who experience adverse reactions or have any questions about their medication should seek medical attention. Any suspected adverse reactions should also be reported via the MHRA Yellow Card scheme.

Additional information

The final date for recalled stock to be received for credit is 06 March 2026. For stock enquiries please contact Advanz Pharma Customer Care Services on +44 (0) 208 588 9441 or email customercare@advanzpharma.com

For medical information enquiries please contact Advanz Pharma Medical Information on +44 (0) 208 588 9131 or email medicalinformation@advanzpharma.com