mhra
MHRA announces recall of two Pedmarqsi batches over particulate risk
Norgine is recalling two batches of Pedmarqsi 80 mg/mL solution for infusion. The pharmacy and wholesaler-level recall requires no additional action by patients.
What Changed
Norgine Pharmaceuticals Limited is recalling batches 458273 and 475287 of Pedmarqsi 80 mg/mL solution for infusion, according to an MHRA Class 2 medicines recall issued on 12 October 2026. The action follows a risk of particulate matter identified during routine stability investigations.
The notice states that users have not reported adverse reactions related to this issue. Norgine has confirmed that the issue is currently limited to the two recalled batches, but investigations concerning all other batches remain ongoing.
Who Is Affected
The recall operates at pharmacy and wholesaler level. Pharmacies, wholesalers and healthcare professionals holding the affected batches should follow the stock instructions in the notice.
Patients do not need to take additional recall action. The medicine is normally administered by healthcare professionals in hospital. Patients experiencing adverse reactions or with questions about the medicine are advised to seek medical attention. Suspected adverse reactions should also be reported through the MHRA Yellow Card scheme.
Regulatory and Technical Implications
The notice concerns a medicine containing sodium thiosulfate, with PLGB number 20011/0078. Other batches remain available for continued use.
Healthcare professionals are reminded of the Patient Information Leaflet instruction to inspect vial contents visually for particulate matter and discoloration before administration. The notice also states that inline filters may be used with this product; it does not describe their use as mandatory.
Manufacturer Actions
Norgine is recalling the two identified batches while continuing investigations into other batches. Healthcare professionals must stop supplying affected batches immediately, quarantine all remaining stock and return it using their supplier’s approved process.
Medical information enquiries can be directed to MedInfo@norgine.com and stock control enquiries to UKIsupport@norgine.com. Recipients are also asked to share a copy of the notice with relevant contacts.
Confirmed Dates
The notice was published and issued on 12 October 2026. Both affected batches have an expiry date of December 2026.
Batch 458273 was first distributed on 9 January 2025; batch 475287 was first distributed on 25 September 2025. The instruction to stop supply is immediate, but the notice provides no separate return deadline.
Official Source
Source: MHRA, “Class 2 Medicines Recall: Norgine Pharmaceuticals Limited, Pedmarqsi 80 mg/mL solution for infusion, EL(26)A/42”. DMRC reference: DMRC - 41054154.
https://www.gov.uk/drug-device-alerts/class-2-medicines-recall-norgine-pharmaceuticals-limited-pedmarqsi-80-mg-slash-ml-solution-for-infusion-el-26-a-slash-42
Source and related services
Class 2 Medicines Recall: Norgine Pharmaceuticals Limited, Pedmarqsi 80 mg/mL solution for infusion, EL(26)A/42 ↗Source date: 12/10/2026
This news provides general information and does not replace device-specific legal or conformity assessment advice.