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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Critical RiskFDA Drug
Medications & Supplements/Prescription Drugs

Zenzedi (Dextroamphetamine Sulfate) Recalled Due to Labeling Mix-up

Agency Publication Date: February 1, 2024
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Summary

Azurity Pharmaceuticals, Inc. is recalling 4,662 bottles of Zenzedi (dextroamphetamine sulfate) 30 mg tablets because the bottles may contain a different medication due to a labeling mix-up. Taking the wrong medication could cause unintended side effects or prevent a patient's condition from being properly treated. If you believe you have this product, you should contact your healthcare provider or pharmacist for guidance immediately.

Risk

Taking an incorrect medication in place of the prescribed dextroamphetamine sulfate poses a serious health risk, as the patient may experience adverse reactions from the wrong drug or see their existing medical condition worsen due to a lack of proper treatment.

What You Should Do

  1. The recalled product is Zenzedi (dextroamphetamine sulfate) 30 mg tablets sold in 30-count bottles with NDC 24338-856-03 and lot number F230169A (Exp. 06/30/2025).
  2. Identify your medication by checking the side of the 30-count white plastic bottle for lot number F230169A and the expiration date 06/30/2025.
  3. If you have health concerns, contact your healthcare provider or pharmacist. Return any unused product to the place of purchase for a refund, throw it away, or contact Azurity Pharmaceuticals, Inc. for further instructions.
  4. Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional questions.

Your Remedy Options

You have 2 options:

πŸ’°Option 1: Full Refund
How to: Contact your healthcare provider or pharmacist for guidance, or return any unused product to the place of purchase for a refund
πŸ—‘οΈOption 2: Dispose of Product
How to: Throw the product away. For prescription medications, a DEA take-back location or pharmacy mail-back program is preferred when available.

Affected Products

Product: Zenzedi (Dextroamphetamine Sulfate) (30 mg)
Variants: 30 mg, Tablets
Lot Numbers:
F230169A (Exp. 06/30/2025)
NDC:
24338-856-03

Mfd. for: Arbor Pharmaceuticals, LLC., Atlanta, Georgia, 30328

Product Images

Image of bottle with label, Zenzedi Rx only 30 mg

Image of bottle with label, Zenzedi Rx only 30 mg

Image of tablets of Zenzedi 30 mg, light yellow hexagonal tablet debossed with β€œ30” on one side and β€œMIA” on the other side

Image of tablets of Zenzedi 30 mg, light yellow hexagonal tablet debossed with β€œ30” on one side and β€œMIA” on the other side

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 93786
Status: Resolved
Manufacturer: Azurity Pharmaceuticals, Inc.
Sold By: Pharmacies
Manufactured In: United States
Units Affected: 4,662 bottles
Distributed To: Nationwide
Agency Last Updated: February 12, 2024

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES Β· FDA Press Release Β· Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.