Cholesterol medication (statins) recalls
FDA drug recall list
Statins such as atorvastatin are recalled for failed quality tests like dissolution. Keep taking your medicine and ask your pharmacist whether your lot is affected.
FDA data updated Last synced
- Reports mentioning it
- 145
- Class I (serious)
- 1
- Class II
- 102
- Class III
- 42
Key facts: cholesterol medication (statins) recalls
- The FDA has published 145 drug enforcement reports mentioning cholesterol medication (statins) since 2012, as of October 7, 2026.
- 1 of them were Class I, the most serious category, where a product could cause serious health problems or death.
- The most recent was reported on Jan 14, 2026: Rosuvastatin Tablets, USP, 10 mg, Rx Only, 50 Tablets (5 x 10) Unit Dose per carton, Ma… (AvKARE), Class II.
- Source: U.S. Food and Drug Administration enforcement reports via openFDA. See our sources policy.
Latest 145 cholesterol medication (statins) recalls
- Jan 14, 2026Rosuvastatin Tablets, USP, 10 mg, Rx Only, 50 Tablets (5 x 10) Unit Dose per carton, Ma…Drug · AvKAREOut of specification for dissolution.Class II
- Oct 22, 2025Atorvastatin Calcium Tablets USP, 80 mg, Rx Only, a)Drug · Ascend Laboratories, LLCFailed Dissolution SpecificationsClass II
- Oct 22, 2025Atorvastatin Calcium Tablets USP, 20 mg, Rx Only, a)Drug · Ascend Laboratories, LLCFailed Dissolution SpecificationsClass II
- Oct 22, 2025Atorvastatin Calcium Tablets USP, 10 mg, Rx Only a) 90-count bottle (NDC 67877-511-90), b)Drug · Ascend Laboratories, LLCFailed Dissolution SpecificationsClass II
- Oct 22, 2025Atorvastatin Calcium Tablets USP, 40 mg, Rx Only, a)Drug · Ascend Laboratories, LLCFailed Dissolution SpecificationsClass II
- Jun 18, 2025Ezetimibe and Simvastatin Tablets, 10mg/40mg, 90-count bottle, Rx only, Manufactured by…Drug · Glenmark Pharmaceuticals Inc., USAFailed 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.Class III
- Apr 16, 2025Pravastatin Sodium Tablets, USP, 80mg, a)Drug · Glenmark Pharmaceuticals Inc., USACGMP DeviationsClass II
- Apr 16, 2025Pravastatin Sodium Tablets, 20mg, a)Drug · Glenmark Pharmaceuticals Inc., USACGMP DeviationsClass II
- Apr 16, 2025Pravastatin Sodium Tablets, USP, 20mg, a)Drug · Glenmark Pharmaceuticals Inc., USACGMP DeviationsClass II
- Apr 16, 2025Pravastatin Sodium Tablets 80mg, 90-count bottle, Rx Only, Manufactured by: Glenmark Ph…Drug · Glenmark Pharmaceuticals Inc., USACGMP DeviationsClass II
- Rosuvastatin Tablets 40mg, 30-count bottle, Rx Only, Manufactured by: Glenmark Pharmace…
- Atorvastatin Calcium Tablets USP 40 mg, 1000-count bottle, Rx Only, Manufactured for: B…
- Atorvastatin Calcium Tablets, USP, 40mg, Rx only, 1000 Tablets per bottle, Manufactured…
- Pravastatin Sodium Tablets, USP 80mg, packaged in a) 90-count bottle
- NEXLIZET (bempedoic acid and ezetimibe) tablets, 180 mg/10 mg, 30-count bottle, Rx only…
- Nexlizet (bempedoic acid and ezetimibe), 180ng/18mg, 30 tablets, Rx only, Manufactured…
- Simvastatin USP, 10 mg, Rx only, Intas Pharm, Limited Ahmedabad 380 054 India Pkg By: P…
- Simvastatin USP 20 mg, Rx only, Intas Pharm
- Simvastatin USP 40 mg, Rx only, Intas Pharm
- Atorvastatin Calcium Tablets, USP, 10 mg, 30-count bottles, Rx Only, Repackaged By: Nor…
- Simvastatin 10 mg tablets, packaged in a) 30-count bottles (NDC 70518-0064-01) and b) 9…
- Atorvastatin Calcium Tablets, USP, 10 mg, 90-count bottle, Rx only, Manufactured: Accor…
- Simvastatin Tablets, USP, 80 mg, 90-count bottle, Rx only, Manufactured for: Accord Hea…
- Rosuvastatin Tablets, USP, 5mg, 30-count bottle, Rx only, Manufactured: Accord Healthca…
- Simvastatin 40 mg tablets, packaged in a) 30-count bottles (NDC 70518-0060-01) and b) 9…
- Atorvastatin Calcium Tablets, USP, 20 mg, packaged in: a) 90-count bottle (NDC 68788-76…
- Atorvastatin 10 mg tablets, packaged in a) 30-count bottles (NDC 70518-1946-00) and b)…
- Pravastatin Sodium Tablets, USP, 20 mg, 90-count bottle, Rx only, Manufactured for: Acc…
- Simvastatin Tablets, USP, 10 mg, 90-count bottle, Rx only, Manufactured for: Accord Hea…
- Simvastatin Tablets, USP, 20 mg, Packaged as: a) 90-count bottle (NDC 68788-9869-9)
- Atorvastatin 20 mg tablets, packaged in a) 30-count bottles (NDC 70518-1977-00) and b)9…
- Simvastatin Tablets, USP, 40 mg, Packaged as: a) 90-count bottle (NDC 68788-9868-9)
- Rosuvastatin 40mg tablets, packaged in a) 45-count bottles (NDC 70518-1311-01), and b)…
- Rosuvastatin 5mg tablets, 30-count bottles, Rx only, Repackaged by: RemedyRepack Inc
- Rosuvastatin Tablets, USP, 10 mg, Packaged as: a) 30-count bottle (NDC 68788-7086-3)
- Rosuvastatin 5mg tablets, 30-count bottles, Rx only, Repackaged by: RemedyRepack Inc
- Rosuvastatin 10mg tablets, packaged in a) 30-count bottles (NDC 70518-0375-03 and 70518…
- Simvastatin, USP, 5 mg Tablets, Rx Only, Packaged as a 90-count bottle
- Simvastatin, USP, 40 mg, Rx Only, Packaged as a 90-count bottle
- Simvastatin, USP, 10 mg Tablets, Rx Only, Packaged as a a) 30-count bottle
- Simvastatin, USP, 20 mg Tablets, Rx Only, Packaged as a a) 30-count bottle
- Atorvastatin Calcium Tablets USP 80 mg* Rx Only, Packaged as a) 90 Tablets NDC 16729-04…
- Atorvastatin Calcium Tablets USP 40 mg* Rx Only, Packaged as a) 90 Tablets NDC 16729-04…
- Atorvastatin Calcium Tablets USP, 10 mg* Rx Only, Packaged as a) 90 Tablets NDC 16729-…
- Pravastatin Sodium Tablets USP, 80 mg, Rx Only, 90- count bottle, Manufactured for: Acc…
- Simvastatin Tablets USP 40 mg Rx Only, Packaged as: a) 90-count tablets NDC 16729-006-1…
- Pravastatin Sodium Tablets USP, 40 mg, Rx Only, 1,000-count bottle Manufactured for: Ac…
- Rosuvastatin Tablets, USP 20 mg* Rx Only, Packaged as: a) 90-count bottle NDC 16729-28…
- Simvastatin Tablets USP 20 mg Rx Only, Packaged as: a) 90-count bottle NDC 16729-005-15
- Simvastatin Tablets USP 5 mg Rx Only, Packaged as: a) 90-count bottle NDC 16729-156-15
- Simvastatin Tablets USP 80 mg Rx Only, Packaged as: a) 90-count bottle NDC 16729-007-15
- Simvastatin Tablets, USP, 10 mg, Rx Only, Packaged as: a) 90-count bottle NDC 16729-004-15
- Rosuvastatin Tablets, USP 40 mg* Rx Only, Packaged as: a) 30-count bottle NDC 16729-287-10
- Atorvastatin Calcium Tablets USP 20 mg* Rx Only, Packaged as a) 90 Tablets NDC 16729-0…
- Rosuvastatin Tablets, USP, 10 mg*, Rx Only, Packaged as: a) 90-count bottle
- Rosuvastatin Tablets, USP, 5 mg*, Rx Only, Packaged as: a) 90-count bottle
- Pravastatin Sodium Tablets USP, 10 mg, Rx Only, Packaged as: a) 90-count bottle NDC 167…
- Pravastatin Sodium Tablets USP 20 mg, Rx Only, 90-count bottle, Manufactured for: Accor…
- Ezetimibe and Simvastatin Tablets, 10 mg/40mg, a) 90 Tablets, b) 500 tablets, Rx only,…
- Ezetimibe and Simvastatin Tablets, 10 mg/80mg, 500 tablet bottles, Rx only, Manufacture…
- Dr. Reddy's Ezetimibe and Simvastatin Tablets, 10 mg/40 mg, a) 30 count (NDC 43598-743-…
- Dr. Reddy's Ezetimibe and Simvastatin Tablets, 10 mg/20 mg, a) 30 count (NDC 43598-744-…
- Dr. Reddy's Ezetimibe and Simvastatin Tablets, 10 mg/80 mg, a) 30 count (NDC 43598-745-…
- Dr. Reddy's Ezetimibe and Simvastatin Tablets, 10 mg/40 mg, 500 count bottles, Rx Only…
- Dr. Reddy's Ezetimibe and Simvastatin Tablets, 10 mg/10 mg, a) 90 count (NDC 43598-742-…
- Atorvastatin Calcium Tablets, USP 10 mg, 500-count bottles, Rx Only, Dr
- EZETIMIBE AND SIMVASTATIN TABLETS 10-10MG 30
- Atorvastatin Calcium Tablets, USP 10 mg*, Rx Only, 500 count bottle, Mfd By: Dr
- Atorvastatin Calcium Tablets, 40mg, packaged in a) 90-count bottles
- Simvastatin Tablets, USP 40mg 90-count bottles, Rx Only, Distributed by: Aurobindo Phar…
- Atorvastatin Calcium Tablets, USP 40 mg, Rx only, 500-count bottle, Manufactured by: Su…
- Caduet (amlodipine besylate/atorvastatin calcium) Tablets, 10 mg/20 mg*, 30-count bottl…
- Caduet (amlodipine besylate/atorvastatin calcium) Tablets, 10 mg/10 mg*, 30-count bottl…
- Atorvastatin Calcium Tablets, USP, 10 mg*, 90-count bottle, Rx Only, Manufactured for:…
- Atorvastatin Calcium Tablets, USP 40 mg*, 1,000 count bottles, Rx Only, Manufactured by…
- Simvastatin Tablets, USP 40 mg
- Atorvastatin Calcium Tablet USP 80 mg, a) 90 count (NDC 67877-0514-90) and b) 500 count…
- Pravastatin Sodium Tablets USP, 20 mg, 500-count bottle, Rx Only, Manufactured by: Glen…
- Ezetimibe and Simvastatin Tablets 10mg/80 mg, 1000-count bottles, Rx only, Manufacture…
- Atorvastatin Calcium tablets, 40 mg, 500-count bottle, Rx only, Mfd By: Dr
- Atorvastatin Calcium Tablets, 40 mg*, packaged as a) 90-count bottle (NDC 55111-123-90…
- Atorvastatin Calcium Tablets, 20 mg*, 90-count bottle, Rx Only, Mfd
- Atorvastatin Calcium Tablets, 80 mg*, 90-count bottles, Rx Only, Mfd
- Atorvastatin Calcium Tablets, 10 mg*, 90-count bottle, Rx Only, Mfd
- Atorvastatin Calcium Tablets 10 mg, a) 90 count and b) 500 count bottles, Rx only, Mfd…
- Atorvastatin Calcium Tablets 40 mg, 90 count bottles, Rx only, Mfd by: Dr
- Atorvastatin Calcium Tablets 20 mg, a) 90 count and b) 500 count bottles, Rx only, Mfd…
- Pravastatin Sodium Tablets, USP, 10 mg, 30-count bottles, packaged in 12 x 30 tablets f…
- Pravastatin Sodium Tablets, USP, 20 mg, 30-count bottles, packaged in 12 x 30 tablets f…
- Simvastatin Tablets, USP, 40 mg, 1000-count bottle, Rx only, Manufactured for: Camber P…
- FOR EXPORT ONLY Atorvastatin calcium Film-Coated Tablets a) 80 mg SMT Tabs Bulk, b) 40…
- Pravastatin Sodium Tablets, USP, 40 mg, 30-count bottle, Rx only, Packaged for: Interna…
- Pravastatin Sodium USP, tablets, 40 mg, 90-count bottle, Rx only, Manufactured for: Lup…
- Pravastatin Sodium Tablets, USP, 10 mg, packaged in a) 90-count bottles (NDC 55111-229-…
- Atorvastatin Calcium 40mg Tablet, 30-count bottles, Rx only, Pk By Safecor Health Wobur…
- Atorvastatin Calcium Tablets, 10 mg*, packaged in a) 90-count bottles (NDC 0378-3950-77)
- Atorvastatin Calcium Tablets, 40 mg*, packaged in a) 90-count bottles (NDC 0378-3952-09…
- Atorvastatin Calcium Tablets, 10 mg*, 100-count Unit Dose Tablets (10 x 10) per carton,…
- Atorvastatin Calcium Tablets, 20 mg*, packaged in a) 90-count bottles (NDC 0378-3951-09…
- Atorvastatin Calcium Tablets, 80 mg*, packaged in a) 90-count bottles (NDC 0378-3953-09…
- Simvastatin Tablets, USP 5 mg Rx only, a) 90 count (NDC 24658-0300-90) and b) 1000 coun…
- Atorvastatin Calcium 40 mg, 10 tablets per blister,100-count package, Rx Only Manufact…
- Atorvastatin Calcium 10 mg, 10 tablets per blister,100-count package, Rx Only Manufact…
- Atorvastatin Calcium 20 mg, 10 tablets per blister,100-count package, Rx Only Manufact…
- Atorvastatin Calcium 80 mg, 10 tablets per blister,100-count package, Rx Only Manufact…
- Vytorin (ezetimibe and simvastatin) tablets, 10 mg/20 mg, each tablet contains 10 mg ez…
- Amlodipine besylate and Atorvastatin calcium Tablets, 10 mg/80 mg, 30 Count Bottles, Rx…
- Amlodipine besylate and Atorvastatin calcium Tablets,2
- Amlodipine besylate and Atorvastatin calcium Tablets, 10 mg/20 mg, Packaged in a) 30 Co…
- Amlodipine besylate and Atorvastatin calcium Tablets, 5 mg/20 mg, Packaged in a) 30 Cou…
- Amlodipine besylate and Atorvastatin calcium Tablets,10 mg/40 mg, Packaged in a) 30 Cou…
- Amlodipine besylate and Atorvastatin calcium Tablets, 2
- Amlodipine besylate and Atorvastatin calcium Tablets, 2
- Amlodipine besylate and Atorvastatin calcium tablets, 5mg/10mg, packaged in a)30-count…
- Amlodipine besylate and Atorvastatin calcium tablets, 10mg/10mg, packaged in a)30-count…
- Amlodipine besylate and Atorvastatin calcium tablets, 10mg/40mg, 90-count bottle, Rx On…
- Amlodipine besylate and Atorvastatin calcium tablets, 5mg/40mg packaged in a)30-count b…
- Simvastatin active pharmaceutical ingredient packaged in varying grams or kg in bags or…
- Ezetimibe active pharmaceutical ingredient packaged in varying grams or kg in bags or d…
- Simvastatin Tablets, USP, 40mg, Rx Only, 90 count bottles, Manufactured by: Micro Labs…
- Simvastatin Tablets, USP, 20mg a) 90- count bottle (42517-0020-10), b) 1000-count-bottl…
- Simvastatin Tablets, USP, 80mg, Rx Only, 90 count bottles, Manufactured by: Micro Labs…
- Simvastatin Tablets, USP, 10 mg, Rx Only, 90 count bottles, Manufactured by: Micro Labs…
- Atorvastatin Calcium 40 MG Tablet, MFG: Apotex NDC# 6050525808
- Liptruzet (ezetimibe and atorvastin) tablets,10 mg/40 mg, a) 30 count blister (NDC 6…
- Liptruzet (ezetimibe and atorvastin) tablets,10 mg/20 mg, a) 30 count blister (NDC 6…
- Liptruzet (ezetimibe and atorvastin) tablets,10 mg/10 mg, a) 30 count blister (NDC 6…
- Liptruzet (ezetimibe and atorvastin) tablets,10 mg/80 mg, a) 30 count blister (NDC 6…
- Atorvastatin Calcium Tablets, 10 mg, 90-count tablets per bottle, Rx only, Manufactured…
- ATORVASTATIN CALCIUM, Tablet, 10 mg, Rx only, Distributed by: AidaPak Service, LLC
- ATORVASTATIN CALCIUM, Tablet, 20 mg, Rx only, Distributed by: AidaPak Service, LLC
- SIMVASTATIN, Tablet, 40 mg, Rx only, Distributed by: AidaPak Service, LLC
- ATORVASTATIN CALCIUM, Tablet, 80 mg, Rx only, Distributed by: AidaPak Service, LLC
- ROSUVASTATIN CALCIUM, Tablet, 5 mg, Rx only, Distributed by: AidaPak Service, LLC
- ATORVASTATIN CALCIUM, Tablet, 40 mg, Rx only, Distributed by: AidaPak Service, LLC
- SIMVASTATIN, Tablet, 5 mg, Rx only, Distributed by: AidaPak Service, LLC
- ATORVASTATIN CALCIUM Tablet, 20 mg, Rx only, Distributed by: AidaPak Service, LLC
- SIMVASTATIN Tablet, 20 mg, Rx only, Distributed by: AidaPak Service, LLC
- ATORVASTATIN CALCIUM, Tablet, 80 mg, Rx only, Distributed by: AidaPak Service, LLC
- Glenmark Pravastatin Sodium Tablets ,40 mg, 90-count bottle (NDC 68462-197-90), Rx only…
- Atorvastatin Calcium Tablets, 10 mg, 90 tablets per bottle, Rx only, Manufactured for:…
- Atorvastatin Calcium Tablets, 20 mg, 90 tablets per bottle, Rx only, Manufactured for:…
- Atorvastatin Calcium Tablets, 40 mg, a) 90 tablets per bottle, b) 500 tablets per bottl…
- Atorvastatin Calcium Tablets, 10 mg, 90-count tablets per bottle, Rx only, Manufactured…
- Lipitor (Atorvastatin calcium)
Questions about cholesterol medication (statins) recalls
Is there a cholesterol medication (statins) recall right now?
There are no new FDA cholesterol medication (statins) recall reports in the last 90 days as of October 7, 2026. The most recent was “Rosuvastatin Tablets, USP, 10 mg, Rx Only, 50 Tablets (5 x 10) Unit Dose per carton, Ma…” from AvKARE (Class II), reported Jan 14, 2026. FDA reports can appear weeks after a recall starts, so also check the FDA's official recall notices.
What should I do with a recalled cholesterol medication (statins) product?
If you have a recalled cholesterol medication (statins) product, compare the lot number and expiration date with the recall. Don't stop taking a prescription medicine on your own: call your pharmacist or doctor, who can confirm whether your supply is affected and arrange a replacement. In an emergency, call 911 or Poison Control at 1-800-222-1222.
How do I know if my cholesterol medication (statins) product is part of the recall?
Open the recall in the list on this page and compare the brand, product size, lot or UPC code, and best-by or expiration date with your package. A match on the product name alone doesn't mean your item is affected. You can also search by lot number on the FindMyRecall homepage.
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