Naproxen Sodium Tablet
FDA Recall NDC 68462-178
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 5 recorded enforcement report(s) associated with Naproxen Sodium (NDC 68462-178). A significant event, classified as Class II, was initiated on Mar 13, 2025 by Glenmark Pharmaceuticals Inc., Usa. The reported reason for this action was: "CGMP Deviations"
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
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
Class II Ongoing
CGMP Deviations
Mar 13, 2025
Apr 16, 2025
N/A
Recall Profile & Regulatory Data
Event ID
96474
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
Glenmark Pharmaceuticals Inc., USA
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
U.S. Nationwide
Product Description
Naproxen Sodium Tablets, USP, 550mg, 100-count bottles, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc. USA, Mahwah, NJ 07430. NDC# 68462-179-01
Batch or Lot Expiration Information
Lot# 17231956, exp. date Aug-25
Affected Packages Involved in this Recall
68462-188-01Product
68462-188-05Product
68462-189-01Product
68462-189-05Product
68462-190-30Product
68462-190-50Product
68462-190-01Product
68462-190-05Product
68462-178-01Product
68462-178-05Product
68462-179-01Product
68462-179-05Product
Class II Ongoing
Labeling: Label Mix-Up-Indomethacin bottles may be labeled as Naproxen
Nov 07, 2023
Dec 06, 2023
N/A
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
Naproxen Tablets, USP 250mg, 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 68462-188-01.
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
68462-188-01Product
68462-188-05Product
68462-189-01Product
68462-189-05Product
68462-190-30Product
68462-190-50Product
68462-190-01Product
68462-190-05Product
68462-178-01Product
68462-178-05Product
68462-179-01Product
68462-179-05Product
Class II Terminated
CGMP Deviations
Aug 27, 2021
Sep 29, 2021
a) 31248 bottles; b) 300 bottles
Recall Profile & Regulatory Data
Event ID
88591
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Glenmark Pharmaceuticals Inc., USA
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide.
Termination Date
Oct 04, 2023
Product Description
Naproxen Sodium Tablets, USP 550 mg Rx Only Manufactured by: Glenmark Pharmaceuticals Inc., USA 4147 Goldmine Road Monroe, NC 28110 Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430 a) 100 Tablets NDC 68462-179-01; b) 500 Tablets NDC 68462-179-05
Batch or Lot Expiration Information
Lot# Lots: a) 29190082 Exp. 09/30/2021; 29190083 Exp. 09/30/2021; 29190084 Exp. 10/31/2021; 29190085 Exp. 10/31/2021; 29200001 Exp. 12/31/2021; 29200003 Exp. 01/31/2022; 29200004 Exp. 01/31/2022; 29200005 Exp. 01/31/2022; 29200012 Exp. 02/28/2022; 29200013 Exp. 02/28/2022; b) 29200010 Exp. 02/28/2022
Affected Packages Involved in this Recall
68462-188-01Product
68462-188-05Product
68462-189-01Product
68462-189-05Product
68462-190-30Product
68462-190-50Product
68462-190-01Product
68462-190-05Product
68462-178-01Product
68462-178-05Product
68462-179-01Product
68462-179-05Product
Class II Terminated
CGMP Deviations
Aug 27, 2021
Sep 29, 2021
9552 bottles
Recall Profile & Regulatory Data
Event ID
88591
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Glenmark Pharmaceuticals Inc., USA
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide.
Termination Date
Oct 04, 2023
Product Description
Naproxen Sodium Tablets, USP 275 mg 100 Tablets Rx Only NDC 68462-178-01 Manufactured by: Glenmark Pharmaceuticals Inc., USA 4147 Goldmine Road Monroe, NC 28110 Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430
Batch or Lot Expiration Information
Lot# Lots: 29190087 Exp. 10/31/2021; 29190088 Exp. 10/31/2021; 29190089 Exp. 10/31/2021; 29200077 Exp. 11/30/2022; 29200078 Exo, 11/30/2022
Affected Packages Involved in this Recall
68462-188-01Product
68462-188-05Product
68462-189-01Product
68462-189-05Product
68462-190-30Product
68462-190-50Product
68462-190-01Product
68462-190-05Product
68462-178-01Product
68462-178-05Product
68462-179-01Product
68462-179-05Product
Class II Terminated
Labeling: Label Mix-Up: Bottles labeled as Naproxen Tablets USP, 500 mg, 100-count may contain 90-count Pravastatin Sodium Tablets, 40 mg.
Jul 06, 2012
Oct 03, 2012
unknown
Recall Profile & Regulatory Data
Event ID
63264
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Glenmark Generics Inc., USA
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide
Termination Date
Aug 13, 2015
Product Description
NAPROXEN TABLETS USP, 500 mg, 100-count Tablets per bottle, Rx only, Manufactured by: Glenmark Generics Ltd., Colvale-Bardez, Goa 403513, India; Manufactured for: Glenmark Generics Inc., USA, Mahwah, NJ 07430; NDC 68462-190-01.
Batch or Lot Expiration Information
Lot# : 02112930, 02112934, 02112941, Exp 09/14; 2112985, 02112986, 02113334, Exp 10/14; 02113360, 02113372, 02113420, 02113606, 02113663, 02113664, Exp 11/14.
Affected Packages Involved in this Recall
68462-188-01Product
68462-188-05Product
68462-189-01Product
68462-189-05Product
68462-190-30Product
68462-190-50Product
68462-190-01Product
68462-190-05Product
68462-178-01Product
68462-178-05Product
68462-179-01Product
68462-179-05Product
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.
