Lisdexamfetamine 40 mg bottles recalled after being filled with 30 mg capsules
Lisdexamfetamine Dimesylate Capsules 40 mg, lot 25280726A, distributed by Lannett, are recalled because a bottle labeled 40 mg contained 30 mg capsules. 8,544 bottles are affected.
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: Rubric level 3 covers risk-of-harm products where injury has not yet been reported; a bottle labeled at one strength containing another could lead to a patient taking the wrong dose, and no injuries are reported.
Plain-English summary
Lisdexamfetamine Dimesylate Capsules, 40 mg, in 100-count bottles and available on prescription only, distributed by Lannett Company, Inc. of Philadelphia, Pennsylvania, NDC 0527-4664-37, are being recalled. The affected product is lot 25280726A with an expiry of 03/2027, and the recall covers 8,544 bottles distributed nationwide.
The recall was issued because of a label mix-up: a bottle labeled as Lisdexamfetamine Dimesylate Capsules 40 mg contained Lisdexamfetamine Dimesylate Capsules 30 mg. The FDA classified the action as Class II.
Patients should check the lot number on their bottle against the recall and speak to their pharmacist about a replacement supply. Anyone unsure whether their capsules match the labeled strength should ask their pharmacist before taking them.
The recalled product
- Product
- LISDEXAMFETAMINE DIMESYLATE (LISDEXAMFETAMINE DIMESYLATE)
- Brand
- LISDEXAMFETAMINE DIMESYLATE
- Manufacturer
- Lannett Company Inc.
- Category
- Drug — Central Nervous System
- Affected units
- 8,544
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 #: 25280726A
- Exp. Date 03/2027
UPCs (6)
- 0305274664379
- 0305274666373
- 0305274661378
- 0305274665376
- 0305274667370
- 0305274663372
Distribution
Distributed nationwide across the United States.
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