Buspirone Hydrochloride Tablet
FDA Recall NDC 29300-477
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 1 recorded enforcement report(s) associated with Buspirone Hydrochloride (NDC 29300-477). A significant event, classified as Class III, was initiated on Apr 13, 2026 by Unichem Pharmaceuticals (usa), Inc.. The reported reason for this action was: "Subpotent drug"
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
Reported Recall Events
Class III Ongoing
Subpotent drug
Apr 13, 2026
May 13, 2026
10,875 Bottles
Recall Profile & Regulatory Data
Event ID
98728
Classification
Class III
Enforcement Status
Ongoing
Recalling Firm
Unichem Pharmaceuticals USA Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
USA Nationwide
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.
Batch or Lot Expiration Information
Lot# Lot: ZBUL25001, Exp 12/31/2027
Affected Packages Involved in this Recall
29300-244-01Product
29300-244-05Product
29300-245-01Product
29300-245-05Product
29300-246-01Product
29300-246-18Product
29300-246-05Product
29300-246-16Product
29300-247-16Product
29300-247-01Product
29300-247-05Product
29300-477-16Product
29300-477-01Product
29300-477-18Product
29300-477-05Product
29300-478-16Product
29300-478-01Product
29300-478-05Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
