Independent register of U.S. FDA drug recalls · updated Oct 10, 2026
RxRecalls Get alerts
Class II · Moderate risk Terminated Initiated Jun 10, 2022 (4 years ago)

Zileuton Extended-Release Tablets

Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.

Why it was recalled

Failed Dissolution Specifications: Out of specification test results observed in dissolution testing during long term stability study.

Cause type: Dissolution failure

The tablet or capsule did not dissolve within specification. Dissolution controls how much drug the body absorbs; a failure can change the effective dose. All dissolution failure recalls.

What was recalled

Zileuton Extended-Release Tablets, 600 mg, 120-count bottle, Rx only, Manufactured for Lupin Pharmaceuticals, Inc., Baltimore, MD 21202 by Lupin Limited, Nagpur-441108, India, NDC 68180-169-16

Affected NDC 68180-0169-16

Compare with the code on your package — it is the most precise check available.

Drug: Zileuton

Recalling firm
Lupin Pharmaceuticals Inc.
NDC code
68180-169-16
Origin
MD, United States
Initiated by
Voluntary: Firm initiated
FDA recall number
D-1150-2022 · FDA notice

Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.

Other Zileuton recalls

See all
Class II · Moderate risk

ZYFLO CR (zileuton)

Failed Dissolution Specifications: Out of specification result for dissolution.

Terminated Dissolution failure Chiesi USA, Inc. NDC 10122-902-12 D-1341-2019

Other recalls by Lupin Pharmaceuticals Inc.

All 2022 recalls