Indomethacin Capsule
FDA Recall NDC 68462-302

FDA Enforcement Report: View Recall Date, Reasons, and Safety Status

Active & Historical Enforcement Reports

The FDA has identified 2 recorded enforcement report(s) associated with Indomethacin (NDC 68462-302). A significant event, classified as Class II, was initiated on Nov 07, 2023 by Glenmark Pharmaceuticals Inc., Usa. The reported reason for this action was: "Labeling: Label Mix-Up-Indomethacin bottles may be labeled as Naproxen"

This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.

Reported Recall Events

D-0123-2024ONGOINGD-0606-2018TERMINATED

November 2023 Class II Recall: Labeling

Recall Number
D-0123-2024
Class II Ongoing
Reason for Recall
Labeling: Label Mix-Up-Indomethacin bottles may be labeled as Naproxen
Initiated
Nov 07, 2023
Reported
Dec 06, 2023
Quantity
37,200 bottles

Recall Profile & Regulatory Data

Event ID
93368
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
Glenmark Pharmaceuticals Inc., USA
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide
Product Description
Indomethacin 25mg Capsules, USP, 100-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Ltd. Colvale-Bardez, Goa 403513, India, Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430, NDC 68462-406-01
Batch or Lot Expiration Information
Lot# 19231903; Exp 4/2025
Lot# 19231858; Exp 4/2025
Lot# 19231881; Exp 4/2025
Lot# 19233484; Exp 8/2025
Lot# 19233490; Exp 8/2025
Affected Packages Involved in this Recall
68462-406-01Product
68462-406-10Product
68462-302-01Product
68462-302-05Product

March 2018 Class III Recall: Labeling

Recall Number
D-0606-2018
Class III Terminated
Reason for Recall
Labeling: Incorrect Instructions: bottles incorrectly labeled with the usual adult dosage of "One or two capsules 2 or 3 times a day." rather than the correct usual adult dosage of "One capsule 2 or 3 times a day.
Initiated
Mar 19, 2018
Reported
Apr 04, 2018
Quantity
109,080 Bottles

Recall Profile & Regulatory Data

Event ID
79570
Classification
Class III
Enforcement Status
Terminated
Recalling Firm
Glenmark Pharmaceuticals Inc., USA
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the United States.
Termination Date
Dec 16, 2019
Product Description
Indomethacin Capsules USP, 50 mg, 100-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Ltd., Colvale-Bardez, Goa 403513, India; Manufactured for: Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ 07430, NDC 68462-302-01.
Batch or Lot Expiration Information
Lot# : 19172776, 19172794, Exp 07/19; 19173111, 19173186, 19173188, 19173189, Exp 08/19; 19173852, 19173878, 19173893, Exp 10/19; 19174318, 19174341, Exp 11/19.
Affected Packages Involved in this Recall
68462-406-01Product
68462-406-10Product
68462-302-01Product
68462-302-05Product

About FDA Recall Enforcement Reports

FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.

If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.