Dextroamphetamine Saccharate recall
FDA recall D-0660-2026 · initiated Jun 26, 2026
Lannett Company Inc. recalled Dextroamphetamine Saccharate in Jun 2026 — an FDA Class II recall (D-0660-2026) because Labeling: Label Mix-up: Capsules contain only immediate-release (IR) pellets while labeled as ER capsules.
May cause temporary or medically reversible harm; low probability of serious harm.
Why it was recalled
Labeling: Label Mix-up: Capsules contain only immediate-release (IR) pellets while labeled as ER capsules.
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: 1392 bottles
Details
- Product
- Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate Extended-Release Capsules, 5 mg, Rx Only, 100 capsules, Distributed by: Lannett Company, Inc., Philadelphia, PA 19136, NDC: 0527-0790-37.
- Recalling company
- Lannett Co Inc
- Classification
- Class II
- Status
- Ongoing
- Type
- Voluntary: Firm initiated
- Distribution
- US Nationwide.
- Initiated
- Jun 26, 2026
- FDA report date
- Jul 8, 2026
Frequently asked
- Was Dextroamphetamine Saccharate recalled?
- Lannett Company Inc. recalled Dextroamphetamine Saccharate in Jun 2026 — an FDA Class II recall (D-0660-2026) because Labeling: Label Mix-up: Capsules contain only immediate-release (IR) pellets while labeled as ER capsules. May cause temporary or medically reversible harm; low probability of serious harm.
- Why was Dextroamphetamine Saccharate recalled?
- Per the FDA enforcement record, the reason for recall D-0660-2026 was: Labeling: Label Mix-up: Capsules contain only immediate-release (IR) pellets while labeled as ER capsules.
- Is a recalled Dextroamphetamine Saccharate 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. May cause temporary or medically reversible harm; low probability of serious harm. 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 Dextroamphetamine Saccharate are affected?
- Distributed: US Nationwide.. The recall covers these lots — Lot#: 25285401A, Exp. Date: 04/2027. 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-0660-2026.