A widely prescribed medication for attention-deficit hyperactivity disorder (ADHD) has been recalled across the United States after failing to meet laboratory dissolution standards, according to an enforcement report from the Food and Drug Administration (FDA).
Sun Pharmaceutical Industries Inc. voluntarily initiated the recall on October 28, targeting its lisdexamfetamine dimesylate capsules — a generic version of the brand-name stimulant Vyvanse. The drug is commonly used to improve focus and attention in individuals with ADHD and is also approved for the treatment of Binge Eating Disorder (BED).
FDA Classifies Recall as Class II
The FDA classified the action as a Class II recall on October 30, indicating that the affected medication could cause temporary or medically reversible adverse health effects. While the agency confirmed that certain batches failed to dissolve properly during testing, it did not release specific details about the failure.
Dosage Strengths and Affected Lot Numbers
The recall involves 100-count bottles of lisdexamfetamine dimesylate capsules in seven dosage strengths, ranging from 10 mg to 70 mg. Each dosage strength includes multiple lot numbers with expiration dates between February 2026 and May 2026.
Patients can verify if their medication is affected by checking the lot numbers printed on their bottle labels.
Affected Lots Include:
- 10 mg: AD42468 (Exp. 2/28/26), AD48705 (Exp. 4/30/26)
- 20 mg: AD42469 (Exp. 2/28/26), AD48707 (Exp. 4/30/26)
- 30 mg: AD42470 (Exp. 2/28/26), AD48708 (Exp. 4/30/26)
- 40 mg: AD48709 (Exp. 4/30/26), AD50894 (Exp. 5/31/26)
- 50 mg: AD48710 (Exp. 4/30/26), AD50895 (Exp. 5/31/26)
- 60 mg: AD48711 (Exp. 4/30/26), AD50896 (Exp. 5/31/26)
- 70 mg: AD48712 (Exp. 4/30/26), AD50898 (Exp. 5/31/26)
Patient Guidance and Next Steps
As of now, the FDA has not issued any formal instructions for patients who may still possess the recalled medication. Individuals are advised to contact their pharmacist or healthcare provider for further guidance.
ADHD specialists and therapists emphasize that patients should not discontinue their medication abruptly without medical advice, as sudden cessation may worsen ADHD symptoms or cause withdrawal effects.
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