Information
Unichem Pharmaceuticals USA Inc. Recalls busPIRone Hydrochloride Tablets
This is a Class III recall. This product is unlikely to cause adverse health reactions but violates FDA regulations.
Source: FDA
InfoRecall #D-0511-2026Drug / Pharmaceutical
Unichem Pharmaceuticals USA Inc. Recalls busPIRone Hydrochloride Tablets
Unichem Pharmaceuticals USA Inc. · Class III — Regulatory
Product Description
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.
Reason for Recall
Subpotent drug
FDA Classification
Class III — Regulatory
A situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Distribution
USA Nationwide
Remedy
Consumers should stop using this product. Contact the recalling firm for further instructions regarding this product.
411 Press Analysis
The FDA has classified this as a Class III recall — the lowest severity level — for a pharmaceutical product recalled by Unichem Pharmaceuticals USA Inc. on April 13, 2026. Subpotent drug. This recall covers 10,875 Bottles, distributed in USA Nationwide. Class III recalls typically involve products unlikely to cause health problems but that violate FDA manufacturing or labeling regulations.
Sources: FDA openFDA Enforcement Database
This recall appears in: Drug & Medication Defects.