Xanax Recall 2019: FDA Announces Alprazolam Recall

The Food and Drug Administration announced that Mylan Pharmaceuticals Inc. is conducting a voluntary nationwide recall of one lot of Alprazolam Tablets.

Alprazolam, also known as Xanax, is used for the management of anxiety disorder, the short-term relief of symptoms of anxiety, and the treatment of panic disorder, with or without agoraphobia.

This lot is being recalled due to the potential presence of a foreign substance.

The FDA stated that clinical impact from the foreign material, if present, is expected to be rare, but the remote risk of infection to a patient cannot be ruled out.

To date, Mylan has not received any adverse events related to this batch.

Alprazolam Tablets, USP C-IV 0.5 mg, are packaged in bottles of 500. This batch was distributed in the U.S. between July 2019 and August 2019. The recalled lot is as follows:

NDC: 0378-4003-05

Product Description and Strength: Alprazolam Tablets, USP C-IV 0.5 mg

Size: Bottles of 500

Lot number: 500 8082708

Expiration Date: September 2020

Mylan has notified its distributors and customers by letter and is arranging for return of all recalled products.

Consumers who believe that they have the recalled should contact Stericycle at 1-888-843-0255 for the documentation packet to return the product to Stericycle.

Consumers with questions regarding this recall can contact Mylan Customer Relations at 800.796.9526 or [email protected], Monday through Friday from 8 a.m. – 5 p.m. EST.

Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to using this drug product.