Lisdexamfetamine Dimesylate capsules recalled nationwide for dosage strength label error
Lannett Company Inc. is recalling 8544 bottles of Lisdexamfetamine Dimesylate 40mg capsules distributed nationwide. Bottles labeled as 40mg capsules actually contain 30mg 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 involving a dosage strength discrepancy on a controlled prescription drug. While no illnesses or injuries have been reported, the mismatch between labeled strength (40mg) and actual contents (30mg) represents a risk of harm through medication errors, meeting the criterion for Score 3: risk-of-harm products where injury has not yet been reported.
Plain-English summary
Lannett Company Inc. is recalling Lisdexamfetamine Dimesylate Capsules labeled as 40mg and distributed nationwide in 100-count bottles. The recall affects 8544 bottles. This is a prescription-only medication (NDC 0527-4664-37, Lot #25280726A, Exp. 03/2027).
A label mix-up was discovered: bottles labeled as 40mg capsules actually contain 30mg capsules. This dosage discrepancy creates a risk of medication errors if patients or healthcare providers rely on the label for dosing decisions.
Patients and healthcare providers who may have received affected bottles should not rely on the label dosage. Contact your pharmacy or prescribing physician immediately if you believe you have received bottles from this recall lot. Bring the bottle to your healthcare provider or pharmacist for verification and guidance on proper dosing.
The recalled product
- Product
- LISDEXAMFETAMINE DIMESYLATE (LISDEXAMFETAMINE DIMESYLATE)
- Brand
- LISDEXAMFETAMINE DIMESYLATE
- Manufacturer
- Lannett Company Inc.
- Category
- Drug
- Hazard
- dosage-mismatch
- mis-labeling
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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