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

Glenmark Pravastatin Sodium Tablets ,40 mg bottle recalled

Glenmark Generics Inc. USA is recalling Glenmark Pravastatin Sodium Tablets ,40 mg 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 codesLot # 02121059 Exp 03/15 Lot # 02121484 Exp 04/15 Lot # 02121530 Exp 04/15 Lot# 02121665 Exp 05/15 Lot# 02121669 Exp 05/15 Lot# 02121689 Exp 05/15 Lot# 02121705 Exp 05/15 Lot# 02123434 Exp 10/15 Lot# 02123446 Exp 10/15 Lot# 02123633 Exp 11/15 Lot# 02123677 Exp 11/15 Lot# 02123685 Exp 11/15 Lot# 02123695 Exp 11/15 Lot# 02123823 Exp 11/15 Lot# 02123833 Exp 11/15 Lot# 02123836 Exp 11/15 Lot# 02123853 Exp 11/15 Lot# 02123859 Exp 11/15 Lot# 02130021 Exp 12/15 Lot# 02130059 Exp 12/15 Lot# 02130079 Exp 12/15

NDC68462-195, 68462-196, 68462-197, 68462-198

UPC0368462195901, 0368462198902

Quantity recalled246,528 bottles

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-330-2013
FDA event ID: 64995
Recalling firm: Glenmark Generics Inc. USA, Mahwah, NJ
Brand: Pravastatin Sodium
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: Cholesterol 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: Pravastatin Sodium Tablets isbeing recalled due to complaints related to an off-odor described as moldy, musty or fishy in nature.

Product as listed by the FDA

Glenmark Pravastatin Sodium Tablets ,40 mg, 90-count bottle (NDC 68462-197-90), 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: Pravastatin Sodium Tablets isbeing recalled due to complaints related to an off-odor described as moldy, musty or fishy in nature.

Which lots are affected?

Lot # 02121059 Exp 03/15 Lot # 02121484 Exp 04/15 Lot # 02121530 Exp 04/15 Lot# 02121665 Exp 05/15 Lot# 02121669 Exp 05/15 Lot# 02121689 Exp 05/15 Lot# 02121705 Exp 05/15 Lot# 02123434 Exp 10/15 Lot# 02123446 Exp 10/15 Lot# 02123633 Exp 11/15 Lot# 02123677 Exp 11/15 Lot# 02123685 Exp 11/15 Lot# 02123695 Exp 11/15 Lot# 02123823 Exp 11/15 Lot# 02123833 Exp 11/15 Lot# 02123836 Exp 11/15 Lot# 02123853 Exp 11/15 Lot# 02123859 Exp 11/15 Lot# 02130021 Exp 12/15 Lot# 02130059 Exp 12/15 Lot# 02130079 Exp 12/15

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

This product is part of a recall event; the main page for the event is Glenmark Gabapentin Tablets, a) 600mg bottle recalled.

Reported	Class	Recall	Company	Reason	Where
22 May 2013	CLASS III	Glenmark Gabapentin Tablets, a) 600mg bottle recalledGabapentin	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 Gabapentin Tablets, a) 600mg bottle recalledGabapentin	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 Pravastatin recalls

All 17

Reported	Class	Recall	Company	Reason	Where
16 Apr 2025Drug	CLASS II	Pravastatin Sodium Tablets 80mg recalled by Glenmark PharmaceuticalsPravastatin Sodium	Glenmark Pharmaceuticals Inc., USA	Manufacturing (CGMP) Deviations	Nationwide
16 Apr 2025Drug	CLASS II	Pravastatin Sodium Tablets, USP, 20mg, a) recalled	Glenmark Pharmaceuticals Inc., USA	Manufacturing (CGMP) Deviations	Nationwide
16 Apr 2025Drug	CLASS II	Pravastatin Sodium Tablets, 20mg, a) recalledPravastatin Sodium	Glenmark Pharmaceuticals Inc., USA	Manufacturing (CGMP) Deviations	Nationwide
16 Apr 2025Drug	CLASS II	Pravastatin Sodium Tablets, USP, 80mg, a) recalled	Glenmark Pharmaceuticals Inc., USA	Manufacturing (CGMP) Deviations	Nationwide
24 Jul 2024Drug	CLASS II	Pravastatin Sodium Tablets, USP 80mg recalledPravastatin Sodium	Glenmark Pharmaceuticals Inc., USA	Potency & Assay	Nationwide