MHRA Class 2 Medicines recall: Nitrofurantoin 100 mg Prolonged-Release capsules (CNX Therapeutics)

Drug alert number: EL (25)A/05

Date issued: 5 February 2025

CNX Therapeutics is recalling the batches listed in this notification as a precautionary measure due to a small number of packs that contain an additional tablet of Nitrofurantoin. The registered product is a capsule containing powder and two yellow tablets.

Nitrofurantoin 100 mg Prolonged-Release capsules (CNX Therapeutics), PL 19635/0006

SNOMED Code: 44125511000001105

Batch No Expiry Date Pack Size First Distributed
24849001 31/07/2026 14 capsules 13/12/2024
24849002 31/07/2026 14 capsules 13/12/2024

Active Pharmaceutical Ingredient: nitrofurantoin

Brief description of the problem

CNX Therapeutics is recalling the above batches as a precautionary measure due to a small number of packs that contain an additional tablet of Nitrofurantoin. The registered product is a capsule containing powder and two yellow tablets. A small percentage of blister pockets have been found to contain an additional yellow tablet alongside the capsule, these are from the manufacturing process and not from broken capsules.

Picture of the extra tablet in a blister of a nitrofurantoin capsule:

Advice for healthcare professionals

Stop supplying the above listed batches immediately. Quarantine all remaining stock and return it to your supplier using your supplier’s approved process.

Should a patient present a pack containing an extra tablet, the tablet may be removed and the patient assured that the capsule is safe to take stating the extra tablet did not come from the capsule.

Full drug alert can be viewed here.

Advice for patients

If you find a pack containing an additional tablet, please take the medication to the dispensing pharmacy you obtained the medicine from. Patients may continue to take capsules from non-impacted packs as prescribed by your healthcare professional.

A small percentage of blister pockets have been found to contain an additional yellow tablet alongside the capsule, these are from the manufacturing process and not from broken capsules.

Patients that have taken the additional tablet with the capsule have ingested a higher dose of nitrofurantoin than was intended, however, the effects are understood and this should not have caused harm.

Patients who experience adverse reactions or have any questions about the medication should seek medical attention. Any suspected adverse reactions should also be reported via the MHRA Yellow Card scheme.

Further Information

For medical information enquiries please contact 0207 821 2840 or medinfo@cnx-therapeutics.com

For stock control enquiries please contact 0207 821 2840 or supplychain@cnx-therapeutics.com