FDA Recalls Zenzedi Dextroamphetamine Sulfate Due to Label Mix-up
The FDA has recalled Zenzedi (Dextroamphetamine Sulfate) 30 mg tablets due to a labeling error. The recall affects 4,662 bottles distributed nationwide.
What this means for you
Highest-severity recall. Risk of serious injury or death is documented or strongly suspected. Stop using the product now and follow the agency's instructions.
Our severity reasoning: This is an FDA Class I recall. The severity rubric specifies that FDA Class I recalls warrant a Critical severity score (5).
Plain-English summary
Azurity Pharmaceuticals, Inc. is recalling Zenzedi (Dextroamphetamine Sulfate) 30 mg tablets due to a labeling error involving a label mix-up.
The recall affects 4,662 bottles with lot number F230169A, expiration 06/30/2025, and NDC 24338-856-03, distributed nationwide. The product is manufactured for Arbor Pharmaceuticals, LLC.
This is an FDA Class I recall. Patients and healthcare providers with product from this lot should contact Azurity Pharmaceuticals, Inc. or the FDA for further information.
The recalled product
- Product
- ZENZEDI (DEXTROAMPHETAMINE SULFATE)
- Brand
- ZENZEDI
- Manufacturer
- Azurity Pharmaceuticals, Inc.
- Category
- Drug — Controlled Substance
- Hazard
- label-mix-up
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot # F230169A
- Exp. 06/30/2025
UPCs (7)
- 0324338854037
- 0324338855034
- 0324338851036
- 0324338850039
- 0324338852033
- 0324338853030
- 0324338856031
Distribution
Distributed nationwide across the United States.
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