BUSPIRONE HYDROCHLORIDE
Recalling Firm / Manufacturer: Unichem Pharmaceuticals USA Inc.
(East Brunswick, NJ, United States)
FDA Recall Number: D-0511-2026
Source Authority Disclaimer: This drug recall notice is published by Questo using official enforcement reports issued by the U.S. Food & Drug Administration (FDA). It is provided for informational, academic, and clinical research purposes only. Patients should not discontinue prescribed treatments without consulting their physician or pharmacist.
Product & Identification Information
Brand, active ingredients, NDC codes, and manufacturer details
Brand / Trade Name
BUSPIRONE HYDROCHLORIDE
Generic Name
BUSPIRONE HYDROCHLORIDE
Active Substance(s)
Buspirone Hydrochloride
Administration Route
Oral
National Drug Code (NDC)
29300-244
Total Quantity Recalled
10,875 Bottles
Official Reason for Recall
Specific hazard or quality defect cited by the FDA
According to the official FDA enforcement report:
Subpotent drug
Full Product Description
Packaging specifications and labeling details
busPIRone Hydrochloride Tablets, USP, 5 mg, 500-count bottle, Rx Only, Manufactured by Unichem Laboratories LTD., Ind, Area, Meerut Road, Ghazibad - 201 003, India Manufactured for: Unichem Pharmaceuticals (USA), Inc. East Brunswick, NJ 08816, NDC 29300-244-05.
Enforcement & Regulatory Details
FDA classification, report dates, and initiation authority
Health Hazard Classification
Class III
Current Action Status
Ongoing
FDA Enforcement Report Date
May 13, 2026
Firm Initiation Date
April 13, 2026
FDA Classification Date
May 01, 2026
Initiation Type
Voluntary: Firm initiated
Affected Lots & Batch Numbers
Product codes, lot numbers, and expiration dates
Lot: ZBUL25001, Exp 12/31/2027
Distribution Information
Geographic scope of affected shipments
USA Nationwide
Safety Guidance & Actions
Standard FDA protocol for patients and healthcare providers
Advisory Notice
This Class III recall involves technical or packaging non-conformities that are not expected to cause adverse health consequences. Consult your pharmacist if you have questions.
Official Source Provenance
Verified regulatory citation from U.S. FDA OpenFDA
Primary Data Source: U.S. Food & Drug Administration (FDA) OpenFDA API
Recall Number: D-0511-2026
Questo Retrieval Date: July 31, 2026 14:36 1785508603UTCC