KidNaps Melatonin Recall EL(26)A/09: All Batches Withdrawn Due to Stability Failure

What Has Been Recalled and Why

Sterling Pharmaceuticals Ltd, operating as a licensed specials manufacturer (MS 32515), and Veriton Pharma Ltd have recalled all batches of KidNaps (Melatonin) 1mg in 1ml Oral Solution. The recall reference is EL(26)A/09 and the reason is out-of-specification stability results.

An out-of-specification stability result means that during routine stability testing, the melatonin content of the product was found to fall below the acceptable specification range before the product's stated expiry date. This indicates the product is degrading faster than intended under normal storage conditions, meaning patients may receive less melatonin per dose than they are prescribed as the product ages in storage.

Because all batches are affected, this is a total product recall rather than a targeted batch-specific action. Any pharmacy or healthcare setting holding KidNaps Melatonin 1mg/1ml Oral Solution from this manufacturer is affected, regardless of the batch number or expiry date on the bottle.

Who Uses KidNaps Melatonin Oral Solution

Melatonin oral solution is primarily prescribed for paediatric patients with sleep disorders, particularly children with neurodevelopmental conditions such as autism spectrum disorder, ADHD, learning disabilities, and visual impairment. These children often have disrupted circadian rhythms that make sleep onset extremely difficult, and melatonin prescribed as a specials product is frequently the clinical treatment of choice.

KidNaps Melatonin is an unlicensed specials product, meaning it does not hold a marketing authorisation but is manufactured under a specials manufacturers licence for named patient supply. The total recall of all batches means that families and carers who rely on this specific product for a child's sleep management will need a prompt alternative source.

For families of children who depend on a consistent nightly melatonin dose to achieve adequate sleep, an abrupt supply disruption carries real consequences. Sleep deprivation affects not only the child but the entire household, and in children with complex neurodevelopmental needs, sleep disruption can also worsen daytime behaviour, school performance, and clinical stability.

Immediate Steps for Pharmacies and Prescribers

1. Quarantine all KidNaps Melatonin 1mg/1ml Oral Solution stock from Sterling Pharmaceuticals / Veriton Pharma immediately. All batches are recalled.
2. Identify all patients currently receiving this product from your dispensing records and notify their prescribers without delay.
3. Arrange alternative supply urgently. Other MHRA-licensed specials manufacturers produce melatonin oral solution in strengths suitable for paediatric use. Contact your specials supplier or a licensed wholesale dealer to identify available alternatives.
4. Do not allow paediatric patients to run out of supply. While melatonin is not associated with severe withdrawal effects, abrupt cessation in a child whose sleep is melatonin-dependent can cause significant disruption and distress.
5. Follow the manufacturers' return instructions for recalled stock.

Sourcing Alternative Melatonin Oral Solution

Melatonin oral solution is manufactured by several MHRA-licensed specials manufacturers in the UK. This recall is specific to Sterling Pharmaceuticals Ltd and Veriton Pharma Ltd's KidNaps product. Melatonin oral solution from other licensed specials manufacturers is not affected by this recall and should be obtainable through the specials supply network.

Prescribers and pharmacies sourcing alternative melatonin oral solution will need to ensure the replacement product is supplied in a strength appropriate for the patient's prescribed dose, and that the new manufacturer's product information and stability data are consistent with the clinical requirement. Melatonin is also available as a licensed product (Slenyto) for children aged 2 to 18 years with autism spectrum disorder and learning disabilities, which may be an appropriate alternative for some patients where the licensed product is suitable.