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OFFICIAL-SOURCE RECALL · UNITED KINGDOM

MHRA Safety Roundup: April 2026 Recall: Assessment Committee (PRAC) issued a recommendation

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CountryUnited KingdomPublishedApril 29, 2026Last updatedApril 29, 2026Official source last checkedAugust 12, 2026 at 8:50 AM UTC

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Product
MHRA Safety Roundup: April 2026
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Why this product was recalled

Assessment Committee (PRAC) issued a recommendation that medicines containing levamisole be withdrawn from the EU market following a safety review confirming leukoencephalopathy as a rare but serious side effect. This follows an EU-wide review which concluded that the benefits of these medicines no longer outweigh their risks for the treatment of parasitic infections in adults and children. Levamisole is a medicine licenced in the EU and indicated for the treatment of mild parasitic infections in adults and children, and is also thought to be a mild immunosuppressant. Levamisole does not hold a current UK marketing authorisation however, levamisole containing medicines are used in the UK off-label in exceptional circumstances to treat children with frequently relapsing or steroid-dependent nephrotic syndrome, to help maintain remission and lower the steroid dosage. Publication of RSV vaccine factsheet The MHRA has

Hazard

Assessment Committee (PRAC) issued a recommendation that medicines containing levamisole be withdrawn from the EU market following a safety review confirming leukoencephalopathy as a rare but serious side effect. This follows an EU-wide review which concluded that the benefits of these medicines no longer outweigh their risks for the treatment of parasitic infections in adults and children. Levamisole is a medicine licenced in the EU and indicated for the treatment of mild parasitic infections in adults and children, and is also thought to be a mild immunosuppressant. Levamisole does not hold a current UK marketing authorisation however, levamisole containing medicines are used in the UK off-label in exceptional circumstances to treat children with frequently relapsing or steroid-dependent nephrotic syndrome, to help maintain remission and lower the steroid dosage. Publication of RSV vaccine factsheet The MHRA has

Official recall notice

MHRA Safety Roundup: April 2026

Agency: Medicines and Healthcare products Regulatory Agency

Official publication date: April 29, 2026

Read the official UK_MHRA recall notice →

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