By: IPP Bureau
Last updated : April 13, 2026 7:11 am
No adverse events reported; recall involves 5 mg 500-count bottles in the US market
Unichem Laboratories has informed stock exchanges that its wholly owned subsidiary, Unichem Pharmaceuticals (USA), Inc., has voluntarily recalled Buspirone Hydrochloride Tablets USP 5 mg in the US market following an out-of-specification (OOS) assay result detected during long-term stability testing.
According to the company’s NSE filing, the recall covers 500-count bottles of the product distributed in the United States. The issue was identified at the 12-month long-term stability time point, prompting the company to initiate the voluntary market action as a quality and patient-safety measure.
Unichem said it has not received any reports of adverse events related to the recall so far, underscoring that the action is precautionary and aligned with its product quality protocols.
In the filing, the company reiterated that it places the highest priority on patient safety and product quality across every stage of manufacturing and supply chain operations.
This development highlights the continued importance of stability surveillance and post-distribution quality monitoring in regulated markets such as the US, where even isolated assay deviations can trigger swift recall action.