Cholesterol Medication recalls

The FDA has published 149 recalls involving cholesterol medication since 2012. The latest was reported on 1 Jul 2026. Most were for manufacturing (cgmp) deviations. Dr. Reddy's Laboratories 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 recalls149since 2012

Last 12 months6reported

Class I11% of total

Ongoing25latest 1 Jul 2026

Recalls per month, last 24 months

click a bar for that month

0Nov '24 0 0 0Feb 0 7 0May 1 0 0Aug 0 4 0Nov 0 1 0Feb 0 0 0May 0 1 0Aug 0 0

Severity split

Class I 1 1%Class II 109 73%Class III 39 26%

Why cholesterol medication is recalled

Companies

Brands

By year

202621%
2025128%
202432%
20234329%
202211%
2021128%
202032%
201975%
2018149%
201796%

Ongoing cholesterol medication recalls

25 active

Reported	Class	Recall	Company	Reason	Where
1 Jul 2026Drug	CLASS II	Fenofibrate Capsules, USP 200 mg recalled by Ajanta Pharma USAFenofibrate	Ajanta Pharma USA	Manufacturing (CGMP) Deviations	Nationwide
14 Jan 2026Drug	CLASS II	Rosuvastatin Tablets, USP, 10 mg recalled by AvKARERosuvastatin	AvKARE	Potency & Assay	Nationwide
22 Oct 2025Drug	CLASS II	Atorvastatin Calcium Tablets USP, 40 mg recalled by Ascend LaboratoriesAtorvastatin Calcium	Ascend Laboratories	Potency & Assay	Nationwide
22 Oct 2025Drug	CLASS II	Atorvastatin Calcium Tablets USP, 10 mg recalled by Ascend LaboratoriesAtorvastatin Calcium	Ascend Laboratories	Potency & Assay	Nationwide
22 Oct 2025Drug	CLASS II	Atorvastatin Calcium Tablets USP, 20 mg recalled by Ascend LaboratoriesAtorvastatin Calcium	Ascend Laboratories	Potency & Assay	Nationwide
22 Oct 2025Drug	CLASS II	Atorvastatin Calcium Tablets USP, 80 mg recalled by Ascend LaboratoriesAtorvastatin Calcium	Ascend Laboratories	Potency & Assay	Nationwide

All cholesterol medication recalls, newest first

149 total

Reported	Class	Recall	Company	Reason	Where
1 Jul 2026Drug	CLASS II	Fenofibrate Capsules, USP 200 mg recalled by Ajanta Pharma USAFenofibrate	Ajanta Pharma USA	Manufacturing (CGMP) Deviations	Nationwide
14 Jan 2026Drug	CLASS II	Rosuvastatin Tablets, USP, 10 mg recalled by AvKARERosuvastatin	AvKARE	Potency & Assay	Nationwide
22 Oct 2025Drug	CLASS II	Atorvastatin Calcium Tablets USP, 40 mg recalled by Ascend LaboratoriesAtorvastatin Calcium	Ascend Laboratories	Potency & Assay	Nationwide
22 Oct 2025Drug	CLASS II	Atorvastatin Calcium Tablets USP, 10 mg recalled by Ascend LaboratoriesAtorvastatin Calcium	Ascend Laboratories	Potency & Assay	Nationwide
22 Oct 2025Drug	CLASS II	Atorvastatin Calcium Tablets USP, 20 mg recalled by Ascend LaboratoriesAtorvastatin Calcium	Ascend Laboratories	Potency & Assay	Nationwide
22 Oct 2025Drug	CLASS II	Atorvastatin Calcium Tablets USP, 80 mg recalled by Ascend LaboratoriesAtorvastatin Calcium	Ascend Laboratories	Potency & Assay	Nationwide
18 Jun 2025Drug	CLASS III	Ezetimibe and Simvastatin Tablets, 10mg/40mg recalledEzetimibe And Simvastatin	Glenmark Pharmaceuticals Inc., USA	Potency & Assay	Nationwide
16 Apr 2025Drug	CLASS II	Rosuvastatin Tablets 40mg recalled by Glenmark PharmaceuticalsRosuvastatin Calcium	Glenmark Pharmaceuticals Inc., USA	Manufacturing (CGMP) Deviations	Nationwide
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) recalledPravastatin 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
16 Apr 2025Drug	CLASS II	Fenofibrate Capsules 67 mg recalled by Glenmark PharmaceuticalsFenofibrate	Glenmark Pharmaceuticals Inc., USA	Manufacturing (CGMP) Deviations	Nationwide
16 Apr 2025Drug	CLASS II	Pravastatin Sodium Tablets, USP, 80mg, a) recalledPravastatin Sodium	Glenmark Pharmaceuticals Inc., USA	Manufacturing (CGMP) Deviations	Nationwide
9 Apr 2025Drug	CLASS II	Atorvastatin Calcium Tablets USP 40 mg recalled by Biocon PharmaAtorvastatin Calcium	Biocon Pharma	Potency & Assay	Nationwide
9 Oct 2024Drug	CLASS II	Atorvastatin Calcium Tablets, USP, 40mg recalledAtorvastatin Calcium	Nivagen Pharmaceuticals	Other	Nationwide
24 Jul 2024Drug	CLASS II	Pravastatin Sodium Tablets, USP 80mg recalledPravastatin Sodium	Glenmark Pharmaceuticals Inc., USA	Potency & Assay	Nationwide
24 Apr 2024Drug	CLASS III	Nexlizet (bempedoic acid and ezetimibe) tablets, 180 mg/10 mg recalledNexlizet	Esperion	Potency & Assay	Nationwide
13 Sep 2023Drug	CLASS III	Nexlizet (bempedoic acid and ezetimibe), 180ng/18mg recalled by EsperionNexlizet	Esperion	Potency & Assay	Nationwide
10 May 2023Drug	CLASS II	Simvastatin USP 40 mg recalled by PD-Rx Pharmaceuticals	PD-Rx Pharmaceuticals	Manufacturing (CGMP) Deviations	Nationwide
10 May 2023Drug	CLASS II	Simvastatin USP 20 mg recalled by PD-Rx Pharmaceuticals	PD-Rx Pharmaceuticals	Manufacturing (CGMP) Deviations	Nationwide
10 May 2023Drug	CLASS II	Simvastatin USP, 10 mg recalled by PD-Rx Pharmaceuticals	PD-Rx Pharmaceuticals	Manufacturing (CGMP) Deviations	Nationwide
3 May 2023Drug	CLASS II	Atorvastatin Calcium Tablets, USP, 10 mg recalledAtorvastatin Calcium	Northwind Pharmaceuticals	Manufacturing (CGMP) Deviations	Nationwide
12 Apr 2023Drug	CLASS II	Rosuvastatin 10mg tablets recalled by RemedyRepack	RemedyRepack	Manufacturing (CGMP) Deviations	Nationwide
12 Apr 2023Drug	CLASS II	Rosuvastatin 5mg tablets recalled by RemedyRepack	RemedyRepack	Manufacturing (CGMP) Deviations	Nationwide
12 Apr 2023Drug	CLASS II	Rosuvastatin Tablets, USP, 10 mg, Packaged as: a) bottle recalled	Preferred Pharmaceuticals	Manufacturing (CGMP) Deviations	Nationwide
12 Apr 2023Drug	CLASS II	Rosuvastatin 5mg tablets recalled by RemedyRepack	RemedyRepack	Manufacturing (CGMP) Deviations	Nationwide
12 Apr 2023Drug	CLASS II	Rosuvastatin 40mg tablets recalled by RemedyRepack	RemedyRepack	Manufacturing (CGMP) Deviations	Nationwide
12 Apr 2023Drug	CLASS II	Simvastatin Tablets, USP, 40 mg, Packaged as: a) bottle recalled	Preferred Pharmaceuticals	Manufacturing (CGMP) Deviations	Nationwide
12 Apr 2023Drug	CLASS II	Atorvastatin 20 mg tablets, packaged in a) 30-count bottles recalled	RemedyRepack	Manufacturing (CGMP) Deviations	Nationwide
12 Apr 2023Drug	CLASS II	Simvastatin Tablets, USP, 20 mg, Packaged as: a) bottle recalled	Preferred Pharmaceuticals	Manufacturing (CGMP) Deviations	Nationwide

Should you stop taking Cholesterol Medication?

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.

Alert me about Cholesterol Medication

One email the day a new recall is posted for Cholesterol Medication. Unsubscribe any time.

At a glance

Latest recall: 1 Jul 2026
First on record: 27 Jun 2012
Class I share: 1%
Ongoing: 25

Drug classes

Injectable & IV Drugs 4,623Pain Medication 1,518Creams, Ointments & Gels 928Blood Pressure Medication 837Compounded Drugs 721Eye Drops 600Hormones & Birth Control 494Antibiotics 492Allergy Medication 348Stomach & Acid Reflux Medication 313Cold & Cough Medicine 312Diabetes Medication 242

Recall classes

CLASS ISerious harm or death possible.

CLASS IITemporary or reversible harm.

CLASS IIIUnlikely to cause harm.