Amphetamine prescription tablets recalled for strength mislabeling error
Lannett Company recalls amphetamine tablets for strength labeling errors. Two bottles in Ohio were found to contain 5mg tablets instead of the labeled 10mg.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: FDA Class II recall involving a pharmaceutical labeling error where incorrect tablet strength was found in affected bottles. No illnesses or injuries have been reported. The hazard is limited to a small number of bottles within the lot, and the mislabeling issue constitutes a minor labeling defect without reported adverse events.
Plain-English summary
Lannett Company Inc. is recalling Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets, 10mg. The affected product is lot 25283185A (expiration February 28, 2027) distributed in Ohio.
Two bottles were found to contain one tablet of the 5mg formulation mixed with the labeled 10mg tablets. This mislabeling could result in patients receiving an incorrect medication dose.
A total of 4,848 bottles of this lot number are included in the recall.
Consumers who have received this medication should stop using it and contact their pharmacy or Lannett Company for return instructions.
The recalled product
- Product
- DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE (DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE)
- Brand
- DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE
- Manufacturer
- Lannett Company Inc.
- Category
- Drug — Prescription Stimulant
- Hazard
- wrong-strength
- mislabeling
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 (1)
- Lot#: 25283185A. Expiry: 02/28/2027
Distribution
Distributed in 1 state:
- OH
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