Sabril (Vigabatrin) recall

14 July 2023

The Medicines and Healthcare products Regulatory Agency (MHRA) has issued a medicines recall affecting some Sabril tablets and granules. Sabril is the brand name for the epilepsy medicine, vigabatrin.

This measure is being taken is as a precaution due to traces of another medicine called tiapride being detected in some batches of the ingredients used to make Sabril. The MHRA highlight that Tiapride is currently not licensed for use in the UK, and it’s use in children has not been thoroughly investigated.

It’s important not to stop taking Sabril tablets or granules without speaking to a doctor. The MHRA say that the risks of suddenly stopping epilepsy medicine are higher than the potential risk from tiapride.

Advice for adults

The MHRA say that people over 18 with batches of the affected medicine do not need to return them for a replacement and can continue to take their medicine as normal. The trace amounts of tiapride are significantly lower than the safe limits for adults.

Advice for children and parents

People aged 17 or below with batches of the affected medicine, or their parents, should return them to their pharmacy for replacement. If medicine from an affected batch has been used, the MHRA advises that you should contact your doctor but keep taking your medication until you have an alternative batch, where possible.

Batches affected:

Sabril 500mg film coated tablets (product code: PL 04425/0171)

• Batch number 2989A with expiry date of April 2025
• Batch number 2988D with expiry date of April 2025
• Batch number 2006B with expiry date of November 2025

Sabril 500mg granules for oral solution (product code: PL 04425/0170)

• Batch number 1994A with expiry date of May 2024
• Batch number 2028B with expiry date of March 2025

Where to get further advice

If you’re unsure if your medicine is affected, experience side-effects or have any other concerns, please speak to your GP or pharmacist for further advice.