Lisdexamfetamine Dimesylate Capsules recall
FDA recall D-0112-2025 · initiated Oct 25, 2024
Lannett Company Inc. recalled Lisdexamfetamine Dimesylate Capsules in Oct 2024 — an FDA Class II recall (D-0112-2025) because Failed Content Uniformity Specifications: Product failed to meet the action limits for stratified content uniformity.
May cause temporary or medically reversible harm; low probability of serious harm.
Why it was recalled
Failed Content Uniformity Specifications: Product failed to meet the action limits for stratified content uniformity.
Wrong strength, or it did not keep
The product did not contain what the label promised, or stopped meeting specification before its expiry date. Under-strength medicine can mean an untreated condition.
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: 1608 bottles
Details
- Product
- Lisdexamfetamine Dimesylate Capsules, 10 mg, 100 Capsules per bottle, Rx only, Distributed by: Lannet Company, Philadelphia, PA 19136, NDC: 0527-4661-37
- Recalling company
- Lannett
- Classification
- Class II
- Status
- Terminated
- Type
- Voluntary: Firm initiated
- Distribution
- Nationwide in the USA
- Initiated
- Oct 25, 2024
- FDA report date
- Dec 11, 2024
Frequently asked
- Was Lisdexamfetamine Dimesylate Capsules recalled?
- Lannett Company Inc. recalled Lisdexamfetamine Dimesylate Capsules in Oct 2024 — an FDA Class II recall (D-0112-2025) because Failed Content Uniformity Specifications: Product failed to meet the action limits for stratified content uniformity. May cause temporary or medically reversible harm; low probability of serious harm.
- Why was Lisdexamfetamine Dimesylate Capsules recalled?
- Per the FDA enforcement record, the reason for recall D-0112-2025 was: Failed Content Uniformity Specifications: Product failed to meet the action limits for stratified content uniformity.
- Is a recalled Lisdexamfetamine Dimesylate Capsules 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 Lisdexamfetamine Dimesylate Capsules are affected?
- Distributed: Nationwide in the USA. The recall covers these lots — Lot: 23274856A, Exp 04/30/2025. 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-0112-2025.