Stock Report

Unichem Pharmaceuticals (USA) Issues Voluntary Recall of Buspirone Hydrochloride Tablets

Posted On : 2026-04-13 08:35:44( TIMEZONE : IST )

Unichem Laboratories Limited has announced that its wholly-owned subsidiary, Unichem Pharmaceuticals (USA), Inc., is initiating a voluntary recall of a specific batch of Buspirone Hydrochloride Tablets, USP. The recall affects products distributed across the United States market.

Recall Details

The recall is focused on a specific strength and packaging configuration:

Product: Buspirone Hydrochloride Tablets, USP

Strength: 5 mg

Pack Size: 500-count bottles

Reason for Recall: Stability Concerns

The action was prompted by an Out-of-Specification (OOS) assay result. This discrepancy was identified during routine quality testing at the 12-month long-term stability time point. An OOS assay result typically indicates that the potency or purity of the active ingredient does not meet the strict regulatory standards required for the product's shelf life.

Unichem has emphasized that as of the date of the announcement, the company has not received any reports of adverse events or health complications related to this recall.

Wholesalers and retailers who have the affected lots in their inventory are expected to stop distribution immediately. Patients currently taking Buspirone Hydrochloride (5 mg) from 500-count bottles should consult their healthcare provider or pharmacist to determine if their specific medication is part of the recalled batch and to arrange for a replacement.

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration (FDA).

Shares of Unichem Laboratories Limited was last trading in BSE at Rs. 339.35 as compared to the previous close of Rs. 334.85. The total number of shares traded during the day was 7474 in over 481 trades.

The stock hit an intraday high of Rs. 353.10 and intraday low of 331.25. The net turnover during the day was Rs. 2536046.00.