Zenzedi (Dextroamphetamine Sulfate) CII Tablets recall
FDA recall D-0323-2024 · initiated Jan 4, 2024
Azurity Pharmaceuticals, Inc. recalled Zenzedi (Dextroamphetamine Sulfate) CII Tablets in Jan 2024 — an FDA Class I recall (D-0323-2024) because Labeling: Label Mix-up.
Most serious — a reasonable probability that use will cause serious harm or death.
Why it was recalled
Labeling: Label Mix-up
Labelling, packaging or a product mix-up
The wrong information — or the wrong medicine — ended up in the pack. A mix-up is a manufacturing failure that can still be dangerous to swallow.
This is a manufacturing or quality failure, not a finding that the medicine is unsafe to take — across every recall we hold, none was issued for that reason. It does not mean the batch was harmless.
Is your product affected? Check the lot number
A recall covers only specific lots. Find the lot number and expiration date on your package and compare them to the affected codes below — if yours is not listed, it was not part of this recall.
Quantity recalled: 4,662 bottles
Details
- Product
- 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
- Recalling company
- Azurity
- Classification
- Class I
- Status
- Terminated
- Type
- Voluntary: Firm initiated
- Distribution
- USA nationwide
- Initiated
- Jan 4, 2024
- FDA report date
- Feb 7, 2024
Frequently asked
- Was Zenzedi (Dextroamphetamine Sulfate) CII Tablets recalled?
- Azurity Pharmaceuticals, Inc. recalled Zenzedi (Dextroamphetamine Sulfate) CII Tablets in Jan 2024 — an FDA Class I recall (D-0323-2024) because Labeling: Label Mix-up. Most serious — a reasonable probability that use will cause serious harm or death.
- Why was Zenzedi (Dextroamphetamine Sulfate) CII Tablets recalled?
- Per the FDA enforcement record, the reason for recall D-0323-2024 was: Labeling: Label Mix-up
- Is a recalled Zenzedi (Dextroamphetamine Sulfate) CII Tablets dangerous to take?
- An FDA recall removes specific lots from the market for a defined reason and does not by itself mean the medicine is unsafe for everyone — your specific lot may never have been affected. Most serious — a reasonable probability that use will cause serious harm or death. Check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This reproduces public FDA data and is not medical advice.
- Which lots of Zenzedi (Dextroamphetamine Sulfate) CII Tablets are affected?
- Distributed: USA nationwide. The recall covers these lots — Lot # F230169A, Exp. 06/30/2025. Check the lot number and expiration date on your package against this list; if yours is not listed, it was not part of recall D-0323-2024.