Limited official informationFDA Drug Enforcement ReportsRecall date: May 13, 2026

busPIRone Hydrochloride Tablets, USP, 5 mg, 500-count bottle, Rx Only, Manufactured by Unichem Laboratories LTD., Ind, Area, Meerut Road,...

Full official 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.

1Is my item affected?

Compare the complete identifiers. Name similarity alone is not a confirmed match.

Identifiers to compare

NDC 29300-244-05
Lot ZBUL25001

Affected variants from the official event record
Product or model	Codes and lots	Quantity	Recall number
busPIRone Hydrochloride Tablets, USP, 5 mg, 500-count bottle, Rx Only, Manufactured by Unichem Laboratories LTD., Ind, Area, Meerut Road, Ghazibad - 201 003,...	Lot: ZBUL25001, Exp 12/31/2027	10,875 Bottles	D-0511-2026

2What is the risk?

The agency's statement is shown without a site-authored severity score.

Subpotent drug

Agency classification: Class III

3What should I do?

Only instructions associated with this recall event qualify as an action.

Consumer action is not available in the associated official record. The site does not infer or generate a replacement.

Verify on the official source

The linked agency record controls if any information differs.

Official evidence

U.S. Food and Drug Administration authoritative
openFDA Drug authoritative

Official scope

Distribution reported by the agency

USA Nationwide

Distribution is context, not a confirmed item match. Compare the model, lot, UPC, NDC, or serial number above.

Material change history

No material affected-item, risk, action, or status change has been recorded since this page entered the tracker.