Exact FDA event identifier

Event 97294

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

Event summary

Timeline bucket: July 22, 2025
Product types: Drug
Classifications: Class II
Statuses: Ongoing
Recalling firm wording: Hikma 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

Lorazepam Injection, USP, 2 mg/mL, 25 x 1mL vials/carton, Rx Only, Manufactured by: Hikma Berkeley Heights, NJ 07922, NDC# 0641-6044-25

D-0551-2025

Recall number: D-0551-2025
Initiated: July 22, 2025
Classification: Class II
Status: Ongoing
Recalling firm: Hikma Pharmaceuticals USA Inc.
Quantity: 382,775 1mL vials

App-derived interpretation

Potency or specification failure reason.potency_specification_failure · v1.0.0

out-of-Specification

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Failed Impurities/Degradation Specifications: An out-of-Specification for total related compounds

Code information

Lot # K24118, exp. date 10/31/2026

Distribution pattern

Distributed Nationwide in the USA