Actavis Recalls Amphetamine Extended-Release Capsules for Dissolution Failure
Actavis Elizabeth LLC is recalling 9,264 bottles of amphetamine extended-release capsules because the product failed to meet dissolution specifications.
The agency’s classification
FDA (Drugs): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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: The recall is classified as FDA Class III, which indicates the violation is not likely to cause adverse health consequences. The hazard is a failure to meet dissolution specifications, which is a quality control issue rather than a direct safety hazard like contamination or mislabeling.
Plain-English summary
Actavis Elizabeth LLC is recalling 9,264 bottles of Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate Extended-Release Capsules, 15 mg. The affected product is identified by Lot # 50077231 and NDC 0228-3063-11. The recall is limited to this specific lot.
The recall was initiated because the product lot exceeded dissolution specifications, meaning the capsules may not release the medication at the intended rate. All other test specifications for the product were met. The product was distributed nationwide.
Consumers who have this specific lot of medication should stop using it and contact their healthcare provider or pharmacist for guidance. The product is a prescription-only medication (C II).
The recalled product
- Product
- DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE, AMPHETAMINE SULFATE (DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE, AMPHETAMINE SULFATE)
- Brand
- DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE, AMPHETAMINE SULFATE
- Manufacturer
- Actavis Elizabeth LLC
- Category
- Drug — Prescription Medication
- Hazard
- Affected units
- 9,264
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 #: 50077231
UPCs (3)
- 0302283059110
- 0302283064114
- 0302283063117
Distribution
Distributed nationwide across the United States.
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