Pravastatin Sodium recalls

Pravastatin Sodium products have been recalled 11 times, most recently on 16 Apr 2025. The recalling company is usually Accord Healthcare. The most common reason is manufacturing (cgmp) deviations.

Total recalls11since 2013

Last 12 months0reported

Class I00% of total

Ongoing3latest 16 Apr 2025

Recalls per month, last 24 months

click a bar for that month

0Dec '24 0 0 0Mar 2 0 0Jun 0 0 0Sep 0 0 0Dec 0 0 0Mar 0 0 0Jun 0 0 0Sep 0 0

Severity split

Class I 0 0%Class II 9 82%Class III 2 18%

Why pravastatin sodium is recalled

Companies

Product types

Cholesterol Medication11100%

By year

2025218%
202419%
2023436%
201919%
2017218%
201319%

Ongoing pravastatin sodium recalls

3 active

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, 20mg, a) recalledPravastatin Sodium	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

All pravastatin sodium recalls, newest first

11 total

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, 20mg, a) recalledPravastatin Sodium	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
8 Mar 2023Drug	CLASS II	Pravastatin Sodium Tablets USP 20 mg recalled by Accord HealthcarePravastatin Sodium	Accord Healthcare	Manufacturing (CGMP) Deviations	PR
8 Mar 2023Drug	CLASS II	Pravastatin Sodium Tablets USP, 10 mg recalled by Accord HealthcarePravastatin Sodium	Accord Healthcare	Manufacturing (CGMP) Deviations	PR
8 Mar 2023Drug	CLASS II	Pravastatin Sodium Tablets USP, 40 mg recalled by Accord HealthcarePravastatin Sodium	Accord Healthcare	Manufacturing (CGMP) Deviations	PR
8 Mar 2023Drug	CLASS II	Pravastatin Sodium Tablets USP, 80 mg recalled by Accord HealthcarePravastatin Sodium	Accord Healthcare	Manufacturing (CGMP) Deviations	PR
17 Apr 2019Drug	CLASS II	Pravastatin Sodium Tablets USP, 20 mg recalledPravastatin Sodium	Glenmark Pharmaceuticals Inc., USA	Other	Nationwide
29 Nov 2017Drug	CLASS II	Pravastatin Sodium USP, tablets, 40 mg recalled by LupinPravastatin Sodium	Lupin	Other	Nationwide
9 Aug 2017Drug	CLASS III	Pravastatin Sodium Tablets, USP, 10 mg recalledPravastatin Sodium	Dr. Reddy's Laboratories	Potency & Assay	Nationwide
22 May 2013Drug	CLASS III	Glenmark Pravastatin Sodium Tablets ,40 mg bottle recalledPravastatin Sodium	Glenmark Generics Inc. USA	Other	Nationwide

About this list

Records come from FDA enforcement reports and USDA FSIS notices, grouped by normalised name. A company operating under several names may appear more than once.