ATLANTA — Several lots of an ADHD medication has been recalled over concerns revealed by testing.
Sun Pharmaceutical Industries Inc. has initiated a voluntary recall of Lisdexamfetamine Dimesylate Capsules due to failed dissolution specifications, the Food and Drug Administration reported.
The recall affects several lots of capsules distributed nationwide in the U.S.
The recall was initiated on Oct. 28, 2025, after an out-of-specification result was observed during a dissolution test at the 12-month long-term stability station.
The capsules are manufactured by OHM Laboratories and distributed by Sun Pharmaceutical Industries Inc.
The recall is classified as Class II, indicating that the use of or exposure to the product may cause temporary or medically reversible adverse health consequences.
The recalling firm, Sun Pharmaceutical Industries Inc., is located at 2 Independence Way, Princeton, NJ.
As of now, the recall is ongoing, and the initial notification to consignees or the public was made via letter.
The following products have been recalled:
- 10 mg, lot AD42468, expires 2/28/2026
- 10 mg, lot AD48705, expires 4/30/2026
- 20 mg, lot AD42469, expires 2/28/2026
- 20 mg, lot AD48707, expires 4/30/2026
- 30 mg, lot AD42470, expires 2/28/2026
- 30 mg, lot AD48708, expires 4/30/2026
- 40 mg, lot AD48709, expires 4/30/2026
- 40 mg, lot AD50894, expires 5/31/2026
- 50 mg, lot AD48710, expires 4/30/2026
- 50 mg, lot AD50895, expires 5/31/2026
- 60 mg, lot AD48711, expires 4/30/2026
- 60 mg, lot AD50896, expires 5/31/2026
- 70 mg, lot AD48712, expires 4/30/2026
- 70 mg, lot AD50898, expires 5/31/2026
Consumers and healthcare providers are advised to check their inventory and discontinue use of the affected lots to avoid potential health risks.
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