Amphetamine extended-release capsules contain immediate-release pellets after label mix-up
Mixed amphetamine salts extended-release capsules, 5 mg, from Lannett are being recalled because the capsules contain only immediate-release pellets. 1,392 bottles 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: Risk-of-harm defect where the capsule releases the full dose immediately instead of over time as labelled, with no injuries reported in the source.
Plain-English summary
Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate Extended-Release Capsules, 5 mg, 100 capsules per bottle, prescription only, distributed by Lannett Company, Inc. of Philadelphia, Pennsylvania, are being recalled. The action covers 1,392 bottles.
The stated reason is a labeling issue described as a label mix-up: the capsules contain only immediate-release pellets while labeled as extended-release capsules. The FDA classified the action as Class II.
The affected lot is 25285401A, expiring 04/2027. Distribution was USA nationwide.
Patients should not stop taking a prescribed medicine without advice. Anyone holding the affected lot should speak to their pharmacist or prescriber and follow the instructions issued by the firm.
The recalled product
- Product
- DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE (DEXTROAMPHETAMINE SULFATE, DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE SULFATE AND AMPHETAMINE ASPARTATE)
- Brand
- DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE
- Manufacturer
- Lannett Company Inc.
- Category
- Drug — Stimulant capsule
- Affected units
- 1,392
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#: 25285401A
- Exp. Date: 04/2027
UPCs (4)
- 0305270791376
- 0305870193310
- 0305270790379
- 0305270794377
Distribution
Distributed nationwide across the United States.
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