Teva Amphetamine Tablets Recalled Due To Incorrect Strength Labeling
Teva Pharmaceuticals is recalling 83,703 bottles of prescription amphetamine tablets nationwide because bottles labeled as 15 mg strength actually contain 20 mg tablets, creating risk of unintended overdose. Patients should contact their pharmacy or healthcare provider.
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 a FDA Class II recall of a controlled prescription drug with significant strength mislabeling (labeled 15 mg, actual 20 mg), creating risk of unintended overdose. However, no illnesses or injuries have been reported, making the hazard theoretical rather than documented.
Plain-English summary
Teva Pharmaceuticals USA Inc is recalling mixed amphetamine salts tablets (dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate, and amphetamine sulfate) due to a labeling error. The recalled product is a 100-count bottle labeled as 15 mg strength but actually containing 20 mg tablets.
The labeling error means that patients taking this medication could unknowingly receive a higher dose than prescribed. Affected bottles bear lot number 100023340 with an expiration date of October 2024.
This recall affects nationwide distribution in the United States. Approximately 83,703 bottles were distributed. Consumers taking this medication should immediately contact their pharmacy or healthcare provider to confirm whether they have received affected product.
Patients should not continue taking tablets from the recalled lot without consulting their healthcare provider about the strength discrepancy. Healthcare providers and pharmacies should identify and quarantine affected stock.
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
- Teva Pharmaceuticals USA Inc
- Category
- Drug — Prescription Amphetamine
- Hazard
- mislabeling
- overdose-risk
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 #: 100023340
- Exp 10/2024
Distribution
Distributed nationwide across the United States.
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