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.
The agency’s classification
FDA (Drugs): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 5/5 (Critical).
Highest-severity recall. The hazard can cause serious injury or death. 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
- Affected units
- 4,662
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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