Reported Feb 23, 2022 · Terminated

Alprazolam Tablets, USP 0.5 mg, packaged in a) 100-count bottles (NDC 67253-901-10), b) 500-count bottles (NDC…

ANI Pharmaceuticals, Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: ANI Pharmaceuticals, Inc. · 210 W Main St · Baudette, MN · 56623-2467

Is this the product you have?

3 of 3 products

Products covered by this recall
#Product as published
1100-count bottles (NDC 67253-901-10)
2500-count bottles (NDC 67253-901-50), and
31000-count bottles (NDC 67253-901-11), Rx only, Distributed by: Par Pharmaceutical Chestnut Ridge, NY 10977
Lot codes and dates

3 of 3 products

Products covered by this recall
#Product as published
119B029A, Exp. Date 02/2022; 19D021A, Exp. Date 04/2022.
219A087B, 19A088B, 19A089B, 19A090B, Exp. Date 02/2022; 19A086B, 19A091B, 19B019B, Exp. Date 02/2022.
319B020C, 19B021C, 19B027C, 19B028C, Exp. Date 02/2022, 19E056C, 19E057C, Exp. Date 05/2022; 19E059C, Exp. Date 06/2022 19G072C, Exp. Date 07/2022
Amount recalled
205,662 bottles

This recall covers 5 products

The agency filed one notice per product. You are reading one of them; the other 4 are below.

Where it was sold

  • Nationwide

Why it was recalled

cGMP Deviations

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA drug enforcement) notice

Notice updated Oct 25, 2022 · Data as of Sep 19, 5:05 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.