Actavis Recalls Alprazolam 1 mg Tablets Due to Significant Tablet Erosion
Actavis Elizabeth LLC is recalling 9,447 bottles of Alprazolam 1 mg tablets because complaints reported significant tablet erosion.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
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 II, and the source text describes a quality defect (tablet erosion) without reporting any illnesses, injuries, or hospitalizations, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Actavis Elizabeth LLC is voluntarily recalling 9,447 bottles of Alprazolam 1 mg Tablets, USP, 500 count. The recall affects Lot # 1826E131 with an expiration date of 04/2015. The product was distributed nationwide.
The recall was initiated after complaints were received regarding significant tablet erosion for the Alprazolam 1 mg tablets. The agency has classified this recall as Class II.
Consumers who have this specific lot of medication should contact their healthcare provider or pharmacist for guidance on how to proceed. The product is a prescription-only medication classified as a Schedule IV controlled substance.
The recalled product
- Product
- ALPRAZOLAM (ALPRAZOLAM)
- Brand
- ALPRAZOLAM
- Manufacturer
- Actavis Elizabeth LLC
- Category
- Drug — Prescription Medication
- Affected units
- 9,447
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 # 1826E131
- Exp 04/2015
Distribution
Distributed nationwide across the United States.
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