Lisdexamfetamine Dimesylate recalls
The FDA has published 11 recalls involving Lisdexamfetamine Dimesylate since 2016. The latest was reported on 5 Nov 2025. Most were for potency & assay. SUN Pharmaceutical Industries has the most recalls in this group. Recalls usually affect specific lots, not every bottle on the market. Check the lot number on each recall page before acting.
Total recalls11since 2016
Last 12 months7reported
Class I00% of total
Ongoing8latest 5 Nov 2025
Recalls per month, last 24 months
click a bar for that monthSeverity split
Class I 0 0%Class II 10 91%Class III 1 9%
Why lisdexamfetamine dimesylate is recalled
Companies
Brands
By year
Ongoing lisdexamfetamine dimesylate recalls
8 active| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Lisdexamfetamine Dimesylate Capsules, 30 mg, CII recalledLisdexamfetamine Dimesylate | SUN Pharmaceutical Industries | Potency & Assay | Nationwide |
| Drug | CLASS II | Lisdexamfetamine Dimesylate Capsules, 40 mg, CII recalledLisdexamfetamine Dimesylate | SUN Pharmaceutical Industries | Potency & Assay | Nationwide |
| Drug | CLASS II | Lisdexamfetamine Dimesylate Capsules, 10 mg, CII recalledLisdexamfetamine Dimesylate | SUN Pharmaceutical Industries | Potency & Assay | Nationwide |
| Drug | CLASS II | Lisdexamfetamine Dimesylate Capsules, 20 mg, CII recalledLisdexamfetamine Dimesylate | SUN Pharmaceutical Industries | Potency & Assay | Nationwide |
| Drug | CLASS II | Lisdexamfetamine Dimesylate Capsules, 70 mg, CII recalledLisdexamfetamine Dimesylate | SUN Pharmaceutical Industries | Potency & Assay | Nationwide |
| Drug | CLASS II | Lisdexamfetamine Dimesylate Capsules, 50 mg, CII recalledLisdexamfetamine Dimesylate | SUN Pharmaceutical Industries | Potency & Assay | Nationwide |
All lisdexamfetamine dimesylate recalls, newest first
11 totalShould you stop taking Lisdexamfetamine Dimesylate?
Not on your own. Most recalls affect specific lots from one manufacturer, and stopping a prescription suddenly can be riskier than the defect. Check your lot number and NDC against the recall, then call the pharmacy that dispensed it for a replacement.