Lisdexamfetamine Dimesylate recalls

Lisdexamfetamine Dimesylate products have been recalled 10 times, most recently on 5 Nov 2025. The recalling company is usually Sun Pharmaceutical Industries. The most common reason is potency & assay.

Total recalls10since 2024

Last 12 months7reported

Class I00% of total

Ongoing8latest 5 Nov 2025

Recalls per month, last 24 months

click a bar for that month

0Oct '24 0 1 0Jan '25 0 0 0Apr 0 0 1Jul 0 1 0Oct 7 0 0Jan '26 0 0 0Apr 0 0 0Jul 0 0

Severity split

Class I 0 0%Class II 10 100%Class III 0 0%

Why lisdexamfetamine dimesylate is recalled

Companies

Sun Pharmaceutical Industries880%
Lannett Company220%

Product types

ADHD Medication10100%

By year

2025990%
2024110%

Ongoing lisdexamfetamine dimesylate recalls

8 active

Reported	Class	Recall	Company	Reason	Where
5 Nov 2025Drug	CLASS II	Lisdexamfetamine Dimesylate Capsules, 30 mg, CII recalledLisdexamfetamine Dimesylate	Sun Pharmaceutical Industries	Potency & Assay	Nationwide
5 Nov 2025Drug	CLASS II	Lisdexamfetamine Dimesylate Capsules, 40 mg, CII recalledLisdexamfetamine Dimesylate	Sun Pharmaceutical Industries	Potency & Assay	Nationwide
5 Nov 2025Drug	CLASS II	Lisdexamfetamine Dimesylate Capsules, 10 mg, CII recalledLisdexamfetamine Dimesylate	Sun Pharmaceutical Industries	Potency & Assay	Nationwide
5 Nov 2025Drug	CLASS II	Lisdexamfetamine Dimesylate Capsules, 20 mg, CII recalledLisdexamfetamine Dimesylate	Sun Pharmaceutical Industries	Potency & Assay	Nationwide
5 Nov 2025Drug	CLASS II	Lisdexamfetamine Dimesylate Capsules, 70 mg, CII recalledLisdexamfetamine Dimesylate	Sun Pharmaceutical Industries	Potency & Assay	Nationwide
5 Nov 2025Drug	CLASS II	Lisdexamfetamine Dimesylate Capsules, 50 mg, CII recalledLisdexamfetamine Dimesylate	Sun Pharmaceutical Industries	Potency & Assay	Nationwide

All lisdexamfetamine dimesylate recalls, newest first

10 total

Reported	Class	Recall	Company	Reason	Where
5 Nov 2025Drug	CLASS II	Lisdexamfetamine Dimesylate Capsules, 30 mg, CII recalledLisdexamfetamine Dimesylate	Sun Pharmaceutical Industries	Potency & Assay	Nationwide
5 Nov 2025Drug	CLASS II	Lisdexamfetamine Dimesylate Capsules, 40 mg, CII recalledLisdexamfetamine Dimesylate	Sun Pharmaceutical Industries	Potency & Assay	Nationwide
5 Nov 2025Drug	CLASS II	Lisdexamfetamine Dimesylate Capsules, 10 mg, CII recalledLisdexamfetamine Dimesylate	Sun Pharmaceutical Industries	Potency & Assay	Nationwide
5 Nov 2025Drug	CLASS II	Lisdexamfetamine Dimesylate Capsules, 20 mg, CII recalledLisdexamfetamine Dimesylate	Sun Pharmaceutical Industries	Potency & Assay	Nationwide
5 Nov 2025Drug	CLASS II	Lisdexamfetamine Dimesylate Capsules, 70 mg, CII recalledLisdexamfetamine Dimesylate	Sun Pharmaceutical Industries	Potency & Assay	Nationwide
5 Nov 2025Drug	CLASS II	Lisdexamfetamine Dimesylate Capsules, 50 mg, CII recalledLisdexamfetamine Dimesylate	Sun Pharmaceutical Industries	Potency & Assay	Nationwide
5 Nov 2025Drug	CLASS II	Lisdexamfetamine Dimesylate Capsules, 60 mg, CII recalledLisdexamfetamine Dimesylate	Sun Pharmaceutical Industries	Potency & Assay	Nationwide
3 Sep 2025Drug	CLASS II	Lisdexamfetamine Dimesylate Capsules, 40 mg recalled by Lannett CompanyLisdexamfetamine Dimesylate	Lannett Company	Packaging Defects	Nationwide
23 Jul 2025Drug	CLASS II	Lisdexamfetamine Dimesylate Capsules, 60 mg, CII recalledLisdexamfetamine Dimesylate	Sun Pharmaceutical Industries	Potency & Assay	Nationwide
11 Dec 2024Drug	CLASS II	Lisdexamfetamine Dimesylate Capsules, 10 mg recalled by Lannett CompanyLisdexamfetamine Dimesylate	Lannett Company	Other	Nationwide

About this list

Records come from FDA enforcement reports and USDA FSIS notices, grouped by normalised name. A company operating under several names may appear more than once.