Nitrofurantoin recall as extra tablet found in packs of UTI antibiotics

Two batches of nitrofurantoin 100mg prolonged-release capsules have been recalled after a small number of packs were found to contain an additional tablet of nitrofurantoin.

Nitrofurantoin is used to treat Urinary Tract Infections (UTIs), and six 100mg modified release capsules can be supplied under the NHS England Pharmacy First Patient Group Direction (PGD) for uncomplicated UTIs in women under 65.

In some packs of 14, a small percentage of blister pockets have been found to contain an additional yellow tablet alongside the antibiotics capsule, the Medicines and Healthcare Products Regulatory Agency (MHRA) has said.

This is in addition to the registered product - a capsule containing powder and two yellow tablets.

It added that these extra tablets had come from the manufacturing process, not from broken capsules.

Picture of the extra tablet in a blister of a nitrofurantoin capsule. Image provided by MHRA.

The issue affects two batches of nitrofurantoin 100mg prolonged-release capsules in pack sizes of 14 capsules, manufactured by CNX Therapeutics.

Pharmacists must stop supplying the batches listed below immediately, quarantine all remaining stock and return it to the supplier.

If patients find a pack containing an extra tablet, they may take the capsules as normal and remove the additional tablet.

And pharmacists can assure patients that the capsule is safe to take, and the extra tablet did not come from the capsule.

If they patients have already taken the additional tablet with the capsule, they will have ingested a higher dose of nitrofurantoin than was intended.

But the MHRA said that the effects of this 'are understood' and this should not have caused harm.

If patients do experience adverse reactions, they should seek medical attention, while any suspected adverse reactions should be reported via the MHRA Yellow Card scheme.