Cholesterol medication (statin) recalls
38 FDA-recorded recalls of cholesterol medications, most recent May 2026 — newest first, straight from the FDA's own database.
Statin and other cholesterol-drug recalls are usually manufacturing, potency or impurity failures rather than a problem with the medicine itself. As with every recall, it names specific lots and manufacturers, and cholesterol control matters — do not stop a statin on your own because of a recall; confirm your specific product against the FDA notice and ask your pharmacist for a replacement if needed.
GSMS Incorporated
Class IIFailed Dissolution Specifications: During 12-month long-term stability testing, subject lot was out of specification (low) for stage 3 dissolution at the 24-hour timepoint.
Golden State Medical Supply Inc. · Jun 17, 2026
Fenofibrate Capsules
Class IICGMP Deviations
Ajanta Pharma USA Inc · Jul 1, 2026
Niacin Extended-release Tablets
Class IIFailed Dissolution Specifications: during 12M LT stability testing OOS low for Stage 3 dissolution at the 24-hour timepoint.
Lannett Company Inc. · Jun 10, 2026
Icosapent Ethyl Capsules
Class IIFailed Tablet/Capsule specifications: Red dots inside capsule and melted capsule caused by oxidized Icosapent ethyl, the active ingredient.
Zydus Pharmaceuticals (USA) Inc · Mar 18, 2026
Pitavastatin Tablets
Class IIIPresence of foreign tablets/capsules: one Pitavastatin tablet 1mg found in bottle of Pitavastatin tablets 2mg
Annora Pharma Private Limited · Mar 25, 2026
Rosuvastatin Tablets
Class IIOut of specification for dissolution.
AvKARE · Jan 14, 2026
Icosapent Ethyl capsules
Class IISubpotent Drug: Due to oxidation caused by leakage of the contents of the capsules
Zydus Pharmaceuticals (USA) Inc · Jan 28, 2026
NIACIN Extended-Release Tablets
Class IIFailed Dissolution Specifications
Golden State Medical Supply Inc. · Nov 26, 2025
Niacin Extended-release Tablets
Class IIFailed Dissolution Specifications
Lannett Company Inc. · Oct 29, 2025
Atorvastatin Calcium Tablets USP
Class IIFailed Dissolution Specifications
Ascend Laboratories, LLC · Oct 22, 2025
Atorvastatin Calcium Tablets USP
Class IIFailed Dissolution Specifications
Ascend Laboratories, LLC · Oct 22, 2025
Atorvastatin Calcium Tablets USP
Class IIFailed Dissolution Specifications
Ascend Laboratories, LLC · Oct 22, 2025
Atorvastatin Calcium Tablets USP
Class IIFailed Dissolution Specifications
Ascend Laboratories, LLC · Oct 22, 2025
Tirzepatide + Niacinamide 13.2 mg + 1.0mg/0.5 mL Inj Sol
Class IILack of Processing Controls.
AEQUITA PHARMACY · Aug 13, 2025
Tirzepatide + Niacinamide 2.2 mg + 1.0mg/0.5 mL Inj Sol
Class IILack of Processing Controls.
AEQUITA PHARMACY · Aug 13, 2025
Tirzepatide + Niacinamide 11.24 mg + 1.0mg/0.5 mL Inj Sol
Class IILack of Processing Controls.
AEQUITA PHARMACY · Aug 13, 2025
Tirzepatide + Niacinamide 16.6 mg + 1.0mg/0.5 mL Inj Sol
Class IILack of Processing Controls.
AEQUITA PHARMACY · Aug 13, 2025
Tirzepatide + Niacinamide 8.8 mg + 1.0mg/0.5 ml Inj Sol
Class IILack of Processing Controls.
AEQUITA PHARMACY · Aug 13, 2025
Tirzepatide + Niacinamide 4.4 mg + 1.0mg/0.5 mL Inj Sol
Class IILack of Processing Controls.
AEQUITA PHARMACY · Aug 13, 2025
Tirzepatide + Niacinamide 6.6 mg + 1.0mg/0.5 mL Inj Sol
Class IILack of Processing Controls.
AEQUITA PHARMACY · Aug 13, 2025
Pitavastatin Tablets
Class IIIFailed Impurity/Degradation Specifications
AvKARE · Jul 9, 2025
Pitavastatin Tablets
Class IIIFailed Impurity/Degradation Specifications
AvKARE · Jul 9, 2025
Pitavastatin Tablets
Class IIIFailed Impurities/Degradation Specifications.
Orient Pharma Co., Ltd. Yunlin Plant · Jul 9, 2025
Pitavastatin Tablets
Class IIIFailed Impurities/Degradation Specifications.
Orient Pharma Co., Ltd. Yunlin Plant · Jul 9, 2025
Icosapent Ethyl Capsules 1 gram
Class IIFailed Tablet/Capsule specifications; a product complaint was reported for burnt or melted capsules. This was determined to be a result of oxidation by leakage of capsule contents.
Zydus Pharmaceuticals (USA) Inc · Jun 18, 2025
Ezetimibe and Simvastatin Tablets
Class IIIFailed Impurities/Degradation Specifications: Out of Specification (OOS) for related substances test for Anhydro Simvastatin at the 06-month time point during long-term stability study.
Glenmark Pharmaceuticals Inc., USA · Jun 18, 2025
Atorvastatin Calcium Tablets USP 40 mg
Class IIFailed dissolution specifications: lower than specifications
BIOCON PHARMA INC · Apr 9, 2025
Fenofibrate Capsules 67 mg
Class IICGMP Deviations
Glenmark Pharmaceuticals Inc., USA · Apr 16, 2025
Pravastatin Sodium Tablets
Class IICGMP Deviations
Glenmark Pharmaceuticals Inc., USA · Apr 16, 2025
Pravastatin Sodium Tablets
Class IICGMP Deviations
Glenmark Pharmaceuticals Inc., USA · Apr 16, 2025
Pravastatin Sodium Tablets
Class IICGMP Deviations
Glenmark Pharmaceuticals Inc., USA · Apr 16, 2025
Pravastatin Sodium Tablets 80mg
Class IICGMP Deviations
Glenmark Pharmaceuticals Inc., USA · Apr 16, 2025
Rosuvastatin Tablets 40mg
Class IICGMP Deviations
Glenmark Pharmaceuticals Inc., USA · Apr 16, 2025
Atorvastatin Calcium Tablets
Class IIPresence of Foreign Tablets/Capsules: A Carbamazepine Extended-Release 400 mg tablet was found in a 1000-count bottle of Atorvastatin Calcium Tablets, USP 40 mg.
Nivagen Pharmaceuticals Inc · Oct 9, 2024
Pravastatin Sodium Tablets
Class IIFailed Dissolution Specifications: results below specifications
Glenmark Pharmaceuticals Inc., USA · Jul 24, 2024
NEXLIZET (bempedoic acid and ezetimibe) tablets
Class IIIFailed dissolution specifications: out-of-specification bempedoic acid dissolution at the 0-month timepoint.
Esperion · Apr 24, 2024
Niacin Extended-Release Tablets
Class IICGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.
SUN PHARMACEUTICAL INDUSTRIES INC · Jan 31, 2024
Niacin Extended-Release Tablets
Class IICGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.
SUN PHARMACEUTICAL INDUSTRIES INC · Jan 31, 2024
How to use this page
A drug appearing here does not mean your prescription is unsafe. Recalls name specific lots and manufacturers — open the recall to see the affected lot numbers, and match them against your bottle. Never stop a blood-pressure, cholesterol, diabetes, antidepressant or antibiotic medicine on your own because of a recall; confirm your lot, then ask your pharmacist for a replacement if it is affected.
Other categories: Blood pressure medication · Eye drop and ophthalmic · Diabetes medication · Antidepressant · Antibiotic. See also the full recalls tracker and the recall report.
Source: the openFDA drug Enforcement (recall) database. Recalls are matched to this category by the drug names in the FDA’s product description; a small number of category recalls may be missed if the description omits the ingredient. Figures are recall events, not units, and reflect our copy of the FDA data, refreshed daily. This is public regulatory data, not medical advice.