Gabapentin Relonchem 50mg/ml Oral Solution
What this means
The MHRA has issued a medicines recall or defect notification. Class 1: risk to life, immediate recall. Class 2: may cause mistreatment or harm, recall within 48 hours. Class 3: unlikely to cause harm, recall within 5 days. Class 4 (defect notification): no recall, caution in use. The medicine remains licensed; only the listed batches are affected. Do not stop treatment without speaking to your doctor or pharmacist.
Class 4 defect notification · DMRC-38460232
| Product | Licence | Active ingredient | GTIN |
|---|---|---|---|
| Gabapentin Relonchem 50mg/ml Oral Solution | PL: 20395/0360 | gabapentin | 5055144203362 |
Batches (expiry): 09E1 (01/10/2026), 150ML (12/11/2025), 11E1 (01/10/2026), 12E1 (01/12/2026), 150ML (02/01/2026), 13E1 (01/12/2026), 14E1 (01/12/2026), 150ML (20/01/2026), 19F1 (01/03/2027), 150ML (08/04/2026), 21F1 (01/04/2027), 150ML (12/05/2026)
Background: Relonchem Limited have informed the MHRA that particles have been observed inside some bottles of Gabapentin Relonchem Oral Solution, identified through a customer complaint. The product storage instructions state: “Do not refrigerate or freeze. Do not store above 25°C.” The investigation by Relonchem Limited has confirmed that these particles are formed due to crystallisation of the preservatives present in the product. The particles may develop if the product is stored at lower temperatures. These particles do not affect the potency of the formulation and the preservative levels remain sufficient in tested samples. Relonchem Limited consider the specific batches remain safe to administer to the patients. Due to this product being critical to supply, the product batches are not being recalled.