The Recall Desk
ModerateFDA (Drugs)·D-1153-2014·Announced 2014-03-19

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.

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: 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
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.