CLASS III Drug recall · Reported 22 May 2013 · FDA Enforcement Report

Glenmark Gabapentin Tablets, a) 600mg bottle recalled

Glenmark Generics Inc. USA is recalling Glenmark Gabapentin Tablets, a) 600mg bottle (, distributed nationwide in the US. The recall was initiated on 5 Apr 2013 and the FDA has classified it as Class III.

Check your package

Lot, batch or date codesa) 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

NDC68462-126, 68462-127

UPC0368462127018, 0368462126011

Quantity recalleda) 33,138 bottles (500ct) ; b)19,278 bottles (500 ct)

Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.

Recall details

Recall number: D-329-2013
FDA event ID: 64995
Recalling firm: Glenmark Generics Inc. USA, Mahwah, NJ
Brand: Gabapentin
Manufacturer: Glenmark Pharmaceuticals Inc., USA
Classification: Class III
Status: Terminated
Recall initiated: 5 Apr 2013
FDA classified: 16 May 2013
Reported: 22 May 2013
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Drug class: Pain Medication

Timeline

5 Apr 2013	Recall initiated by company
16 May 2013	Classified by FDA	+41 days
22 May 2013	Published in enforcement report	+6 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

Product as listed by the FDA

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.

Where it was distributed

Nationwide

Questions about this recall

Why was it recalled?

Chemical Contamination: Gabapentin Sodium tablets is recalled due to complaints related to an off - odor described as moldy, musty or fishy in nature.

Which lots are affected?

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

Where was it sold?

Nationwide

What should I do if I have it?

Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.

What does Class III mean?

Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

2 other products · FDA event 64995

Reported	Class	Recall	Company	Reason	Where
22 May 2013	CLASS III	Glenmark Pravastatin Sodium Tablets ,40 mg bottle recalledPravastatin Sodium	Glenmark Generics Inc. USA	Other	Nationwide
22 May 2013	CLASS III	Glenmark Topiramate Tablets, 200 mg recalledTopiramate	Glenmark Generics Inc. USA	Other	Nationwide

More recalls from Glenmark Generics Inc. USA

All 6

Reported	Class	Recall	Company	Reason	Where
16 Apr 2014Drug	CLASS II	Ranitidine Tablets USP, 150 mg recalled by Glenmark Generics Inc., U	Glenmark Generics Inc. USA	Foreign Material	Nationwide
22 May 2013Drug	CLASS III	Glenmark Topiramate Tablets, 200 mg recalledTopiramate	Glenmark Generics Inc. USA	Other	Nationwide
22 May 2013Drug	CLASS III	Glenmark Pravastatin Sodium Tablets ,40 mg bottle recalledPravastatin Sodium	Glenmark Generics Inc. USA	Other	Nationwide
13 Mar 2013Drug	CLASS III	Montelukast Sodium Tablets, 10 mg (base) recalled	Glenmark Generics Inc. USA	Packaging Defects	Nationwide
3 Oct 2012Drug	CLASS II	Naproxen Tablets recalled by Glenmark Generics Inc., UNaproxen Sodium	Glenmark Generics Inc. USA	Packaging Defects	Nationwide

Other Gabapentin recalls

All 22

Reported	Class	Recall	Company	Reason	Where
29 Oct 2025Drug	CLASS II	Gabapentin Capsules, USP, 100 mg ( blister packs) recalled	The Harvard Drug Group	Potency & Assay	Nationwide
29 Oct 2025Drug	CLASS II	Gabapentin Capsules, USP, 100 mg ( blister pack) recalledGabapentin	The Harvard Drug Group	Potency & Assay	Nationwide
9 Jul 2025Drug	CLASS II	Gabapentin Capsules, USP, 100 mg recalled by The Harvard Drug GroupGabapentin	The Harvard Drug Group	Packaging Defects	Nationwide
9 Jul 2025Drug	CLASS II	Gabapentin Capsules, USP, 100 mg , blister pack recalled	The Harvard Drug Group	Packaging Defects	Nationwide
16 Apr 2025Drug	CLASS III	Gabapentin Capsules, USP 300 mg recalledGabapentin	SUN Pharmaceutical Industries	Packaging Defects	Nationwide