The South African Health Products Regulatory Authority (SAHPRA) has announced a Class II Type B recall of two batches of Levoneptin (gabapentin) capsules.
The affected batches are Levoneptin 100 mg, batch 24142840, and Levoneptin 400 mg, batch 24142842. Both carry expiry dates of 06/2027 and were first distributed in December 2024.
The marketing authorisation holder, Ascend Laboratories Pty Ltd of Sandton City Office Towers, 83 Rivonia Road and 5th Street, 7th Floor, Sandton 2196, initiated the recall after routine evaluation and testing of retained control samples identified an out-of-specification result for individual impurity. The impurity level exceeded established acceptance criteria, indicating potential deterioration in product quality over the shelf life.
Health professionals and distributors must immediately identify, isolate and remove all affected units from inventory. The stock should be returned to DP World Healthcare Logistics. No remaining units of the affected batches may be supplied, distributed or dispensed.
Ascend Laboratories may be contacted on 010 276 0037 for queries. A SAHPRA-approved recall letter has been distributed to all distribution points.
Source: South African Health Products Regulatory Authority (SAHPRA), “Levoneptin 100 and Levoneptin 400 (Gabapentin)”, updated 22 October 2026: https://www.sahpra.org.za/document/levoneptin-100-and-levoneptin-400-gabapentin/
