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TGA recalls Andrographis medicines over anaphylaxis risk; MHRA flags missing levetiracetam safety information

  • 02-10-2026
  • Posted by: Eldaniz Hasanov
  • Category: Regulatory Updates
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Two official safety updates published on 1 October 2026 require attention from pharmacovigilance teams.

TGA: Class I consumer recall of Andrographis medicines

The Therapeutic Goods Administration (TGA) announced Class I consumer recall RC-2026-RN-00747-1 for Nourex Professional Immune Defence 30/60 (batches 194576, 197886, 194828, 198848 and 201158) and Nourex Professional Immune Force 30/60 (batches 147285 and 147286).

TGA cited sustained reports of anaphylaxis associated with Andrographis, including a fatality. Consumers should not use the affected products and should return them to the place of purchase.

Official sources: TGA safety communication and DRAC recall record.

MHRA: missing safety information for Levetiracetam Neuraxpharm

The Medicines and Healthcare products Regulatory Agency (MHRA) published Class 4 Medicines Defect Notification EL(26)A/40, DMRC 40741691, for Levetiracetam Neuraxpharm 250, 500, 750, 1000 and 1500 mg granules for oral solution in sachets. Thirteen batch entries are affected.

The current PIL/SmPC materials omit reference-product information covering possible seizure worsening in SCN8A-associated epilepsy, predisposition to neuroleptic malignant syndrome, very rare obsessive-compulsive disorder, rare DRESS/multiorgan hypersensitivity, and use from one month of age. Treatment should not be stopped; dispensers should provide the supplementary letter.

Official sources: MHRA notice, notification PDF, and supplementary letter.

Why this matters for pharmacovigilance

QPPV, LQPPV and LPPV teams should assess local exposure to the affected products and batches, ensure escalation of serious hypersensitivity reports, and check that current product-information and dispensing controls reflect the regulators’ instructions.

Disclaimer. This material is provided solely for information and pharmacovigilance purposes, based on official communications issued by the Therapeutic Goods Administration and the Medicines and Healthcare products Regulatory Agency and current as of 2 October 2026. It is not medical or legal advice, does not replace the official sources, and does not imply wrongdoing by the manufacturer/marketing authorisation holder or a quality concern affecting the companies’ entire product portfolios. Company and product names are used only to identify the official materials accurately. Decisions should be based on the primary sources, the regulators’ instructions and the approved product information.