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Unrated Drug recall · FDA · Published January 4, 2024

Zenzedi 30mg Tablets Recall: Label Mix-Up Hazard

Azurity Pharmaceuticals recalls Zenzedi (Dextroamphetamine Sulfate) 30mg tablets due to potential label mix-up. This CII prescription drug, sold by Arbor Pharmaceuticals, requires immediate attention for safety.

🇺🇸 FDA recall #D-0323-2024DrugAzurity ›
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Contact the company

Recalling firmAzurity Pharmaceuticals, Inc.841 Woburn St · Wilmington, MA 01887-3414
✎ GovInfoNow plain-language explainer

Azurity Pharmaceuticals is recalling Zenzedi (Dextroamphetamine Sulfate) 30mg tablets because of a potential label mix-up. This could lead to confusion about which medication a patient is taking, especially since it's a controlled substance (CII) that requires a prescription. Read more at govinfonow.com/recall/32891-zenzedi-30mg-tablets-recall-label-mix-up-hazard.

Source Summary by GovInfoNow · govinfonow.com/recall/32891-zenzedi-30mg-tablets-recall-label-mix-up-hazard · Updated August 17, 2026 · FDA enforcement record: FDA #D-0323-2024

Cite this page

“Zenzedi 30mg Tablets Recall: Label Mix-Up Hazard.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/32891-zenzedi-30mg-tablets-recall-label-mix-up-hazard. Based on FDA recall #D-0323-2024 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0323-2024%22&limit=1).

The FDA announced on Jan. 4, 2024, that Azurity Pharmaceuticals voluntarily recalled Zenzedi tablets due to a labeling mix-up hazard. The recall involves 4,662 bottles distributed nationwide.

How to tell if you have it

  • Brand: Azurity
  • Product: Zenzedi (Dextroamphetamine Sulfate) CII Tablets, USP, 30 mg, 30-count bottle
  • NDC: 24338-856-03
  • Lot #: F230169A
  • Expiration: 06/30/2025

The hazard

The recall was issued because of a labeling mix-up involving Zenzedi tablets manufactured for Arbor Pharmaceuticals, LLC. The FDA classified the recall as Class I.

Context

GovInfoNow's records show Azurity has 3 other recalls on record since Aug. 24, 2021. Other recent recalls of similar products include American Health Packaging Buprenorphine Tablets Recall (Aug. 19, 2026), Zydus Mirabegron 25mg Tablets Recall (Aug. 5, 2026), and Annora Pharma Lacosamide Tablets Recall (June 4, 2026).

How to tell if you have this one

Check for Zenzedi (Dextroamphetamine Sulfate) 30mg tablets with NDC 24338-856-03 and lot number F230169A. The product was manufactured for Arbor Pharmaceuticals and sold in the U.S. by prescription.

  • Brand
    Azurity
  • Category
    Drug
Based on the official FDA remedy

What to do — step by step

  1. Check Your Medication

    Verify the product label matches the specific NDC 24338-856-03 and lot number F230169A.

Where it went and when

Where it was distributed

Distributed nationwide.

Alaska: yesAKMaine: yesMEVermont: yesVTNew Hampshire: yesNHWashington: yesWAIdaho: yesIDMontana: yesMTNorth Dakota: yesNDMinnesota: yesMNIllinois: yesILWisconsin: yesWIMichigan: yesMINew York: yesNYRhode Island: yesRIMassachusetts: yesMAOregon: yesORNevada: yesNVWyoming: yesWYSouth Dakota: yesSDIowa: yesIAIndiana: yesINOhio: yesOHPennsylvania: yesPANew Jersey: yesNJConnecticut: yesCTCalifornia: yesCAUtah: yesUTColorado: yesCONebraska: yesNEMissouri: yesMOKentucky: yesKYWest Virginia: yesWVVirginia: yesVAMaryland: yesMDDelaware: yesDEArizona: yesAZNew Mexico: yesNMKansas: yesKSArkansas: yesARTennessee: yesTNNorth Carolina: yesNCSouth Carolina: yesSCDistrict of Columbia: yesDCOklahoma: yesOKLouisiana: yesLAMississippi: yesMSAlabama: yesALGeorgia: yesGAHawaii: yesHITexas: yesTXFlorida: yesFL

FDA distribution: “USA nationwide” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide.

Recall timeline

FDA terminated this recall 8 months after the firm started it.

1. Firm started the recall: Jan 4, 202412. Published in FDA’s Enforcement Report: Feb 7, 202423. FDA classified it Class I: Feb 12, 202434. FDA terminated the recall: Sep 18, 202442024
  1. Firm started the recall
  2. Published in FDA’s Enforcement Report
  3. FDA classified it Class I
  4. FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

✎ GovInfoNow

Questions people ask

Is this product available over the counter?

No, Zenzedi is a prescription-only medication (CII) and requires a valid prescription from a healthcare provider.

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Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

  • Official source: FDA Recall #D-0323-2024 (January 4, 2024) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0323-2024 to see it in context.
  • Plain-language summary written by qwen3:4b on August 17, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
  • GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA