Exact FDA event identifier

Event 98728

1 recalled-product record grouped only because every row carries this exact official event ID.

Event summary

Timeline bucket: April 13, 2026
Product types: Drug
Classifications: Class III
Statuses: Ongoing
Recalling firm wording: Unichem Pharmaceuticals USA Inc.

Dossier provenance

Source snapshots represented here

openFDA Drug Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Device root-cause evidence is not applicable to this event. No grouped product has the official product type device; this is not an unavailable-enrichment finding.

Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

drug · product 1 of 1

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.

D-0511-2026

Recall number: D-0511-2026
Initiated: April 13, 2026
Classification: Class III
Status: Ongoing
Recalling firm: Unichem Pharmaceuticals USA Inc.
Quantity: 10,875 Bottles

App-derived interpretation

Potency or specification failure reason.potency_specification_failure · v1.0.0

Subpotent

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Subpotent drug

Code information

Lot: ZBUL25001, Exp 12/31/2027

Distribution pattern

USA Nationwide