Prescription Drug Lisdexamfetamine Dimesylate Recalled for Failed Content Uniformity
Lannett Company is recalling 1,608 bottles of Lisdexamfetamine Dimesylate 10 mg capsules nationwide due to failed content uniformity. The active ingredient may be unevenly distributed in some capsules.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall for failed content uniformity on a prescription medication, creating potential for improper dosing. No illnesses or injuries have been reported. Per the rubric, risk-of-harm products where no injury has yet been reported score at High (3).
Plain-English summary
Lannett Company, Inc. is recalling Lisdexamfetamine Dimesylate Capsules, 10 mg (1,608 bottles, lot 23274856A, expiration 04/30/2025) nationwide. The FDA determined that the product failed to meet action limits for stratified content uniformity, meaning the active ingredient is not evenly distributed across all capsules in the affected lot.
The recalled product is packaged as 100 capsules per bottle and carries NDC 0527-4661-37. Affected bottles can be identified by lot number 23274856A.
Consumers who have this medication should consult their prescribing healthcare provider about obtaining a replacement or alternative medication. Any affected product from lot 23274856A should be returned to the dispensing pharmacy. Do not discontinue use without medical guidance.
The recalled product
- Product
- LISDEXAMFETAMINE DIMESYLATE (LISDEXAMFETAMINE DIMESYLATE)
- Brand
- LISDEXAMFETAMINE DIMESYLATE
- Manufacturer
- Lannett Company Inc.
- Category
- Drug — Prescription Medication
- Hazard
- improper-dosing
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot: 23274856A
- Exp 04/30/2025
UPCs (6)
- 0305274664379
- 0305274666373
- 0305274661378
- 0305274665376
- 0305274667370
- 0305274663372
Distribution
Distributed nationwide across the United States.
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