CLASS I Drug recall · Reported 7 Feb 2024 · FDA Enforcement Report
Zenzedi (Dextroamphetamine Sulfate) CII Tablets, USP, 30 mg recalled
Azurity Pharmaceuticals is recalling Zenzedi (Dextroamphetamine Sulfate) CII Tablets, USP, 30 mg, distributed nationwide in the US. The recall was initiated on 4 Jan 2024 and the FDA has classified it as Class I.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0323-2024
- FDA event ID
- 93786
- Recalling firm
- Azurity Pharmaceuticals, Wilmington, MA
- Brand
- Zenzedi
- Manufacturer
- Azurity Pharmaceuticals, Inc.
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- 4 Jan 2024
- FDA classified
- 12 Feb 2024
- Reported
- 7 Feb 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Packaging Defects
- Drug class
- ADHD Medication
Timeline
| 4 Jan 2024 | Recall initiated by company | |
| 7 Feb 2024 | Published in enforcement report | +34 days |
| 12 Feb 2024 | Classified by FDA | +5 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Labeling: Label Mix-up
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
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
Where it was distributed
USA nationwide
Questions about this recall
Why was it recalled?
Labeling: Label Mix-up
Which lots are affected?
Lot # F230169A, Exp. 06/30/2025
Where was it sold?
USA nationwide
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class I mean?
Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Azurity Pharmaceuticals
All 4| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | Eprontia (topiramate) oral solution, 25 mg/mL recalledEprontia | Azurity Pharmaceuticals | Potency & Assay | Nationwide |
| Drug | CLASS II | Testosterone Cypionate Injection, USP, CIII, 200 mg/mL recalledTestosterone Cypionate | Azurity Pharmaceuticals | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS I | Firvanq (vancomycin hydrochloride for oral solution) recalledFirvanq | Azurity Pharmaceuticals | Packaging Defects | Nationwide |
Other Dextroamphetamine recalls
All 11| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Dextroamphetamine Saccharate recalled by Lannett CompanyDextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate And Amphetamine Sulfate | Lannett | Packaging Defects | Nationwide |
| Drug | CLASS II | Xelstrym (dextroamphetamine) transdermal system recalledXelstrym | Noven Pharmaceuticals | Packaging Defects | Nationwide |
| Drug | CLASS II | Dextroamphetamine Sulfate Extended-Release Capsules, 10 mg recalled | Actavis | Potency & Assay | Nationwide |
| Drug | CLASS II | Dextroamphetamine Sulfate Tablets USP, 5 mg recalled | Impax Laboratories | Potency & Assay | Nationwide |
| Drug | CLASS II | Dextroamphetamine Sulfate Tablets USP, 10 mg recalled | Impax Laboratories | Potency & Assay | Nationwide |