Agency classClass IIOur severity:High FDA (Drugs)·D-1150-2022·Announced 2022-06-22

Zileuton Extended-Release Tablets recalled for failed dissolution specifications

Lupin Pharmaceuticals is recalling Zileuton Extended-Release Tablets, 600 mg, due to failed dissolution specifications found during stability testing that may affect medication efficacy.

The agency’s classification

FDA (Drugs): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: FDA Class II recall with no reported illnesses or injuries. Failed dissolution specifications represent a risk to drug efficacy. Per rubric, when no injuries are reported and the hazard is theoretical, the maximum score is 3.

Plain-English summary

Lupin Pharmaceuticals Inc. is recalling Zileuton Extended-Release Tablets, 600 mg, 120-count bottles (NDC 68180-169-16) due to failed dissolution specifications. Out-of-specification test results were observed during dissolution testing in a long-term stability study, indicating the tablets may not dissolve properly.

The affected lots are M100070, M100239 (expiring 06/22), M100312 (expiring 09/22), and M100366 (expiring 10/22). Approximately 3,216 bottles were distributed to 10 wholesalers and distributors and one mail order account, with potential nationwide distribution.

Consumers who have received tablets from the affected lots should contact their healthcare provider or pharmacist. Do not stop taking your medication without consulting your healthcare provider.

The recalled product

Product: 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
Manufacturer: Lupin Pharmaceuticals Inc.
Category: Drug
Hazard: dissolution-failure
efficacy-risk
Affected units: 3,216

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 (7)

Lots: M100070
M100239
Exp. 06/22
M100312
Exp.09/22
M100366
Exp.10/22

Distribution

Distributed nationwide across the United States.

Same manufacturer · Lupin Pharmaceuticals Inc.

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