Home / Recalls / Azurity Pharmaceuticals, Inc. / D-0323-2024

D-0323-2024 Class I Terminated

Recalled by Azurity Pharmaceuticals, Inc. — Wilmington, MA

FDA drug recall D-0323-2024 was initiated by Azurity Pharmaceuticals, Inc. on Jan 4, 2024 and is designated Class I. Reason for recall: Labeling: Label Mix-up The recall status is terminated (terminated Sep 18, 2024). Affected quantity: 4,662 bottles.

Recall details

Product Type: Drugs
Report Date: Feb 7, 2024
Initiation Date: Jan 4, 2024
Termination Date: Sep 18, 2024
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 4,662 bottles

Product description

Zenzedi (Dextroamphetamine Sulfate) CII Tablets, USP, 30 mg, 30-count bottle, Rx only, Mfd. for: Arbor Pharmaceuticals, LLC., Atlanta, Georgia, 30328, NDC 24338-856-03

Reason for recall

Labeling: Label Mix-up

Distribution pattern

USA nationwide

Code information

Lot # F230169A, Exp. 06/30/2025

Source

Dataset: openFDA drug recall enforcement reports
FDA record: This recall in openFDA (JSON)
Enforcement Report: Search FDA's Enforcement Report for D-0323-2024
openFDA file date: Nov 10, 2026
Loaded by RegDataLab: Nov 11, 2026

These dates say when openFDA published the data file and when RegDataLab last loaded it.