Pravastatin recalls

The FDA has published 17 recalls involving Pravastatin since 2013. The latest was reported on 16 Apr 2025. Most were for manufacturing (cgmp) deviations. Glenmark Pharmaceuticals Inc., U has the most recalls in this group. Recalls usually affect specific lots, not every bottle on the market. Check the lot number on each recall page before acting.

Total recalls17since 2013

Last 12 months0reported

Class I16% of total

Ongoing6latest 16 Apr 2025

Recalls per month, last 24 months

click a bar for that month

0Oct '24 0 0 0Jan '25 0 0 4Apr 0 0 0Jul 0 0 0Oct 0 0 0Jan '26 0 0 0Apr 0 0 0Jul 0 0

Severity split

Class I 1 6%Class II 14 82%Class III 2 12%

Why pravastatin is recalled

Companies

By year

2025424%
202416%
2023529%
201916%
2018212%
2017318%
201316%

Ongoing pravastatin recalls

6 active

Reported	Class	Recall	Company	Reason	Where
16 Apr 2025Drug	CLASS II	Pravastatin Sodium Tablets 80mg recalled by Glenmark PharmaceuticalsPravastatin Sodium	Glenmark Pharmaceuticals Inc., U	Manufacturing (CGMP) Deviations	Nationwide
16 Apr 2025Drug	CLASS II	Pravastatin Sodium Tablets, USP, 20mg, a) recalledPravastatin Sodium	Glenmark Pharmaceuticals Inc., U	Manufacturing (CGMP) Deviations	Nationwide
16 Apr 2025Drug	CLASS II	Pravastatin Sodium Tablets, 20mg, a) recalledPravastatin Sodium	Glenmark Pharmaceuticals Inc., U	Manufacturing (CGMP) Deviations	Nationwide
16 Apr 2025Drug	CLASS II	Pravastatin Sodium Tablets, USP, 80mg, a) recalledPravastatin Sodium	Glenmark Pharmaceuticals Inc., U	Manufacturing (CGMP) Deviations	Nationwide
24 Jul 2024Drug	CLASS II	Pravastatin Sodium Tablets, USP 80mg recalledPravastatin Sodium	Glenmark Pharmaceuticals Inc., U	Potency & Assay	Nationwide
12 Apr 2023Drug	CLASS II	Pravastatin Sodium Tablets, USP, 20 mg recalled	Preferred Pharmaceuticals	Manufacturing (CGMP) Deviations	Nationwide

All pravastatin recalls, newest first

17 total

Reported	Class	Recall	Company	Reason	Where
16 Apr 2025Drug	CLASS II	Pravastatin Sodium Tablets 80mg recalled by Glenmark PharmaceuticalsPravastatin Sodium	Glenmark Pharmaceuticals Inc., U	Manufacturing (CGMP) Deviations	Nationwide
16 Apr 2025Drug	CLASS II	Pravastatin Sodium Tablets, USP, 20mg, a) recalledPravastatin Sodium	Glenmark Pharmaceuticals Inc., U	Manufacturing (CGMP) Deviations	Nationwide
16 Apr 2025Drug	CLASS II	Pravastatin Sodium Tablets, 20mg, a) recalledPravastatin Sodium	Glenmark Pharmaceuticals Inc., U	Manufacturing (CGMP) Deviations	Nationwide
16 Apr 2025Drug	CLASS II	Pravastatin Sodium Tablets, USP, 80mg, a) recalledPravastatin Sodium	Glenmark Pharmaceuticals Inc., U	Manufacturing (CGMP) Deviations	Nationwide
24 Jul 2024Drug	CLASS II	Pravastatin Sodium Tablets, USP 80mg recalledPravastatin Sodium	Glenmark Pharmaceuticals Inc., U	Potency & Assay	Nationwide
12 Apr 2023Drug	CLASS II	Pravastatin Sodium Tablets, USP, 20 mg recalled	Preferred Pharmaceuticals	Manufacturing (CGMP) Deviations	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

Should you stop taking Pravastatin?

Not on your own. Most recalls affect specific lots from one manufacturer, and stopping a prescription suddenly can be riskier than the defect. Check your lot number and NDC against the recall, then call the pharmacy that dispensed it for a replacement.