Alprazolam recalls: 7 FDA reports
Recalls involving Alprazolam. What was wrong with each batch, and how the FDA graded the risk.
7Reports
0Class I
1Ongoing
2026-04-15Most recent
What the classes mean
The FDA sorts every recall into one of three classes. The class is the whole story. It is also the part people skip.
Class II is the bulk of every list here. That matters. A long list of Class II says something different from one Class I.
By class
By year reported
Checking whether it affects you
The lot or code number is what matters. Not the product name. A recall covers
specific lots. Yours may not be one of them.
Check the code on your package against the report. The FDA keeps the current
list at fda.gov/safety/recalls.
The reports
The text below is quoted from the FDA record word for word.
Xanax XR, alprazolam, extended-release tablets, 3 mg, 60 Tablets bottles, Rx only, Distributed by: Viatris Spe
D-0444-2026 · Class II · reported 2026-04-15 · Ongoing
- Why it was recalled
- Failed Dissolution Specifications
- Product
- Xanax XR, alprazolam, extended-release tablets, 3 mg, 60 Tablets bottles, Rx only, Distributed by: Viatris Specialty LLC, Morgantown, WV 06506, U.S.A, Made in Ireland, NDC 58151-506-91
- Where it went
- US Nationwide.
alprazolam XR extended-release tablets, 3 mg, 60-count bottle, Rx only, Distributed by: Greenstone LLC, Peapac
D-0844-2022 · Class II · reported 2022-05-11 · Terminated
- Why it was recalled
- Failed Dissolution Specifications: low out-of-specification dissolution test results observed.
- Product
- alprazolam XR extended-release tablets, 3 mg, 60-count bottle, Rx only, Distributed by: Greenstone LLC, Peapack, NJ 07977, NDC 59762-0068-1.
- Where it went
- Product was distributed nationwide in the USA
- How much
- 6,789 bottles
Xanax (alprazolam) tablets, 0.25 mg, 100-count bottle, Rx only, Distributed by Pharmacia & Upjohn Co. Division
D-0161-2016 · Class II · reported 2015-11-04 · Terminated
- Why it was recalled
- Subpotent Drug
- Product
- Xanax (alprazolam) tablets, 0.25 mg, 100-count bottle, Rx only, Distributed by Pharmacia & Upjohn Co. Division of Pfizer Inc, NY, NY 10017, NDC 0009-0029-01
- Where it went
- Nationwide
- How much
- 21,120 HDPE bottles
Alprazolam tablets, USP, CIV, 0.25 mg, Rx Only, a) 500 count bottle, b) 1000 count bottle, Distributed by: Gre
D-0326-2015 · Class II · reported 2014-12-31 · Terminated
- Why it was recalled
- Subpotent Drug
- Product
- Alprazolam tablets, USP, CIV, 0.25 mg, Rx Only, a) 500 count bottle, b) 1000 count bottle, Distributed by: Greenstone LLC, Peapack, NJ, 07977, a) NDC 59762-3719-3, b) NDC 59762-3719-4.
- Where it went
- Nationwide
- How much
- 12,310 bottles
Alprazolam Tablets, USP, 0.25mg, Rx only, 1000 tablets, Sandoz Inc., Princeton, NJ --- NDC 0781-1061-10
D-1509-2014 · Class II · reported 2014-08-06 · Terminated
- Why it was recalled
- Presence of Foreign Substance; tablets may contain stainless steel metal particulates
- Product
- Alprazolam Tablets, USP, 0.25mg, Rx only, 1000 tablets, Sandoz Inc., Princeton, NJ --- NDC 0781-1061-10
- Where it went
- Nationwide
- How much
- 1,332 bottles
Alprazolam 1 mg Tablets, USP, 500 count Bottle, Rx Only , C IV, Manufactured by: Actavis Elizabeth LLC 200 Elm
D-1153-2014 · Class II · reported 2014-03-19 · Terminated
- Why it was recalled
- Failed Tablet/Capsule Specifications: Complaints were received for significant tablet erosion for Alprazolam 1 mg.
- Product
- Alprazolam 1 mg Tablets, USP, 500 count Bottle, Rx Only , C IV, Manufactured by: Actavis Elizabeth LLC 200 Elmora Avenue Elizabeth, NJ 07207 USA, NDC 0228-2031-50
- Where it went
- Nationwide
- How much
- 9447 Bottles
Alprazolam Orally Disintegrating Tablets, USP 2 mg, 100 count bottles, Rx Only, MFG. BY ACTAVIS ELIZABETH LLC.
D-018-2014 · Class II · reported 2013-12-04 · Terminated
- Why it was recalled
- Failed Tablet/Capsule Specifications; partial tablet erosion resulting in tablet weights below specification in some tablets
- Product
- Alprazolam Orally Disintegrating Tablets, USP 2 mg, 100 count bottles, Rx Only, MFG. BY ACTAVIS ELIZABETH LLC., Elizabeth, NJ, NDC 0228-4025-11
- Where it went
- Nationwide
- How much
- 756 bottles
Read these counts with three things in mind
A firm with more recalls usually makes more products. A contract packer runs
hundreds of lines. It will out-recall a company with one product whatever either
does. This is not a safety ranking.
Most recalls here are voluntary. A firm found its own fault and pulled the stock.
That is the system working. It lands in this database looking the same as a recall
the FDA had to push for.
Terminated means the FDA considers the recall finished. It is not a verdict.
It does not mean anyone was harmed.
Source: openFDA enforcement reports, retrieved 2026-08-05. FDA dataset last updated 2026-07-29.
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