Gabapentin Tablet
FDA Recall NDC 68462-127

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 Gabapentin (NDC 68462-127). 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.

Reported Recall Events

D-0320-2025ONGOINGD-329-2013TERMINATED

March 2025 Class II Recall: CGMP Deviations

Recall Number
D-0320-2025
Class II Ongoing
Reason for Recall
CGMP Deviations
Initiated
Mar 13, 2025
Reported
Apr 16, 2025
Quantity
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
Gabapentin Tablets 600mg, 500-count bottles, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc. USA, Mahwah, NJ 07430. NDC# 68462-126-05.
Batch or Lot Expiration Information
Lot# 17231015, exp. date Apr-25 17231128, exp. date Apr-25 17231138, exp. date Apr-25 17231139, exp. date Apr-25 17231143, exp. date Apr-25 17231144, exp. date Apr-25 17231848, exp. date Aug-25 17231898, exp. date Aug-25 17231977, exp. date Aug-25 17231978, exp. date Aug-25 17232015, exp. date Aug-25 17232016, exp. date Aug-25 17232017, exp. date Aug-25 17232034, exp. date Aug-25 17232041, exp. date Aug-25 17232396, exp. date Nov-25 17232406, exp. date Nov-25 17232410, exp. date Nov-25 17232490, exp. date Nov-25 17240326, exp. date Jan-26 17240327, exp. date Jan-26 17240383, exp. date Feb-26 17240395, exp. date Feb-26 17241863, exp. date Oct-26 17241869, exp. date Oct-26 17241870, exp. date Oct-26 17231256, exp. date May-25 17231386, exp. date May-25 17231387, exp. date May-25 17231407, exp. date May-25 17231417, exp. date May-25 17231418, exp. date May-25 17231754, exp. date Jul-25 17240085, exp. date Dec-25 17240117, exp. date Dec-25 17240131, exp. date Dec-25
Affected Packages Involved in this Recall
68462-126-01Product
68462-126-05Product
68462-127-01Product
68462-127-05Product

April 2013 Class III Recall: Chemical Contamination

Recall Number
D-329-2013
Class III Terminated
Reason for Recall
Chemical Contamination: Gabapentin Sodium tablets is recalled due to complaints related to an off - odor described as moldy, musty or fishy in nature.
Initiated
Apr 05, 2013
Reported
May 22, 2013
Quantity
a) 33,138 bottles (500ct) ; b)19,278 bottles (500 ct)

Recall Profile & Regulatory Data

Event ID
64995
Classification
Class III
Enforcement Status
Terminated
Recalling Firm
Glenmark Generics Inc., USA
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide
Termination Date
Oct 09, 2014
Product Description
Glenmark Gabapentin Tablets, a) 600mg, 500- count bottle (NDC 68462-126-05), b) 800 mg, 500- count bottle (NDC 68462-127-05), Rx only, Manufactured by Glenmark Generics Ltd.Colvale- Bardez Ltd 403513, India, Manufactured for : Glenmark Generics USA Mahwah, NJ 07430.
Batch or Lot Expiration Information
Lot# a) 600mg:
Lot# 02123419, Exp 10/14
Lot# 02123424, Exp 10/14
Lot# 02123430, Exp 10/14
Lot# 02123492, Exp 10/14
Lot# 02123523, Exp 10/14
Lot# 02123527, Exp 10/14
Lot# 02123532, Exp 10/14
Lot# 02123542, Exp 10/14
Lot# 02123546, Exp 10/14
Lot# 02123551, Exp 10/14
Lot# 02123555, Exp 10/14
Lot# 02123560, Exp 11/14
Lot# 02123566, Exp 11/14
Lot# 02123569, Exp 11/14 b) 800 mg
Lot# 02123440 Exp 10/14
Lot# 02123445 Exp 10/14
Lot# 02123454 Exp 10/14
Lot# 02123465 Exp 10/14
Lot# 02123789 Exp 11/14
Lot# 02123804 Exp 11/14
Lot# 02123821 Exp 11/14
Lot# 02123829 Exp 11/14
Lot# 02123834 Exp 11/14
Lot# 02123841 Exp 11/14
Lot# 02123845 Exp 11/14
Affected Packages Involved in this Recall
68462-126-01Product
68462-126-05Product
68462-127-01Product
68462-127-05Product

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.