CLASS II ONGOING Drug recall · Reported 8 Jul 2026 · FDA Enforcement Report
Dextroamphetamine Saccharate recalled by Lannett Company
Lannett is recalling Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine, distributed nationwide in the US. The recall was initiated on 26 Jun 2026 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0660-2026
- FDA event ID
- 99319
- Recalling firm
- Lannett, Seymour, IN
- Manufacturer
- Lannett Company, Inc.
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 26 Jun 2026
- FDA classified
- 2 Jul 2026
- Reported
- 8 Jul 2026
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Packaging Defects
- Drug class
- ADHD Medication
Timeline
| 26 Jun 2026 | Recall initiated by company | |
| 2 Jul 2026 | Classified by FDA | +6 days |
| 8 Jul 2026 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Labeling: Label Mix-up: Capsules contain only immediate-release (IR) pellets while labeled as ER capsules.
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
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.
Where it was distributed
US Nationwide.
Questions about this recall
Why was it recalled?
Labeling: Label Mix-up: Capsules contain only immediate-release (IR) pellets while labeled as ER capsules.
Which lots are affected?
Lot#: 25285401A, Exp. Date: 04/2027
Where was it sold?
US Nationwide.
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Lannett
All 15| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Niacin Extended-release Tablets, USP, 1,000 mg recalledNiacin | Lannett | Potency & Assay | Nationwide |
| Drug | CLASS III | Primidone Tablets USP, 250mg recalled by Lannett CompanyPrimidone | Lannett | Other | Nationwide |
| Drug | CLASS II | Niacin Extended-release Tablets, USP, 1,000 mg recalledNiacin | Lannett | Potency & Assay | Nationwide |
| Drug | CLASS II | Dextroamphetamine Saccharate, Amphetamine Aspartate recalledDextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate And Amphetamine Sulfate | Lannett | Other | OH |
| Drug | CLASS II | Lisdexamfetamine Dimesylate Capsules, 40 mg recalled by Lannett | Lannett | Packaging Defects | Nationwide |
Other Dextroamphetamine recalls
All 11| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Xelstrym (dextroamphetamine) transdermal system recalledXelstrym | Noven Pharmaceuticals | Packaging Defects | Nationwide |
| Drug | CLASS I | Zenzedi (Dextroamphetamine Sulfate) CII Tablets, USP, 30 mg recalledZenzedi | Azurity Pharmaceuticals | Packaging Defects | Nationwide |
| Drug | CLASS II | Dextroamphetamine Sulfate Extended-Release Capsules, 10 mg recalled | Actavis | Potency & Assay | Nationwide |
| Drug | CLASS II | Dextroamphetamine Sulfate Tablets USP, 5 mg recalled | Impax Laboratories | Potency & Assay | Nationwide |
| Drug | CLASS II | Dextroamphetamine Sulfate Tablets USP, 10 mg recalled | Impax Laboratories | Potency & Assay | Nationwide |