Unichem Pharmaceuticals USA Inc.: Buspirone Hydrochloride Tablets, Usp, 5 Mg, 500-count Bottle

Recall Summary Unichem Pharmaceuticals is recalling buspirone hydrochloride 5 mg tablets (500-count bottles, NDC 29300-244-05) distributed nationwide because the medication is subpotent—meaning it contains less active ingredient than it should. This recall affects prescriptions filled across all U.S. states and Washington, D.C. The medication was manufactured in India for Unichem Pharmaceuticals USA Inc.

Recalling firm
Unichem Pharmaceuticals USA Inc.
Product
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
Subpotent drug
Classification
Class III
Category
drug recall
Country
United States
Agency
U.S. Food and Drug Administration
Recall date
2026-04-13
Status
Ongoing
Areas affected
AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...
Distribution
USA Nationwide

Official recall notice from U.S. Food and Drug Administration

Recall details on Nibble Recalls: https://trynibble.app/recalls/a61e28b8-7fc1-46d1-a158-33be0c8f845b