Atorvastatin Calcium recalls

Atorvastatin Calcium products have been recalled 35 times, most recently on 22 Oct 2025. The recalling company is usually Dr. Reddy's Laboratories. The most common reason is potency & assay.

Total recalls35since 2012

Last 12 months4reported

Class I00% of total

Ongoing6latest 22 Oct 2025

Recalls per month, last 24 months

click a bar for that month

1Oct '24 0 0 0Jan '25 0 0 1Apr 0 0 0Jul 0 0 4Oct 0 0 0Jan '26 0 0 0Apr 0 0 0Jul 0 0

Severity split

Class I 0 0%Class II 23 66%Class III 12 34%

Why atorvastatin calcium is recalled

Companies

Dr. Reddy's Laboratories1234%
Ranbaxy514%
Mylan Pharmaceuticals411%
Ascend Laboratories411%
Accord Healthcare411%
Sun Pharmaceutical Industries13%
Apotex13%
Mylan Institutional, Inc. (d.b.a. UDL Laboratories)13%

Product types

Cholesterol Medication35100%

By year

2025514%
202413%
2023514%
202213%
202139%
202013%
201913%
2018823%
2017514%
201413%

Ongoing atorvastatin calcium recalls

6 active

Reported	Class	Recall	Company	Reason	Where
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
9 Apr 2025Drug	CLASS II	Atorvastatin Calcium Tablets USP 40 mg recalled by Biocon PharmaAtorvastatin Calcium	Biocon Pharma	Potency & Assay	Nationwide
3 May 2023Drug	CLASS II	Atorvastatin Calcium Tablets, USP, 10 mg recalledAtorvastatin Calcium	Northwind Pharmaceuticals	Manufacturing (CGMP) Deviations	Nationwide

All atorvastatin calcium recalls, newest first

35 total

Reported	Class	Recall	Company	Reason	Where
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
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
3 May 2023Drug	CLASS II	Atorvastatin Calcium Tablets, USP, 10 mg recalledAtorvastatin Calcium	Northwind Pharmaceuticals	Manufacturing (CGMP) Deviations	Nationwide
8 Mar 2023Drug	CLASS II	Atorvastatin Calcium Tablets USP 20 mg* recalled by Accord HealthcareAtorvastatin Calcium	Accord Healthcare	Manufacturing (CGMP) Deviations	PR
8 Mar 2023Drug	CLASS II	Atorvastatin Calcium Tablets USP, 10 mg* recalled by Accord HealthcareAtorvastatin Calcium	Accord Healthcare	Manufacturing (CGMP) Deviations	PR
8 Mar 2023Drug	CLASS II	Atorvastatin Calcium Tablets USP 40 mg* recalled by Accord HealthcareAtorvastatin Calcium	Accord Healthcare	Manufacturing (CGMP) Deviations	PR
8 Mar 2023Drug	CLASS II	Atorvastatin Calcium Tablets USP 80 mg* recalled by Accord HealthcareAtorvastatin Calcium	Accord Healthcare	Manufacturing (CGMP) Deviations	PR
6 Apr 2022Drug	CLASS III	Atorvstatin Calcium Tablets, USP 80 mg* recalledAtorvastatin Calcium	Dr. Reddy's Laboratories	Potency & Assay	Nationwide
23 Jun 2021Drug	CLASS III	Atorvastatin Calcium Tablets, USP 10 mg recalledAtorvastatin Calcium	Dr. Reddy's Laboratories	Potency & Assay	Nationwide
2 Jun 2021Drug	CLASS III	Atorvastatin Calcium Tablets, USP 10 mg* recalledAtorvastatin Calcium	Dr. Reddy's Laboratories	Potency & Assay	Nationwide
10 Mar 2021Drug	CLASS III	Atorvastatin Calcium Tablets, 40mg recalled by Dr. Reddy's LaboratoriesAtorvastatin Calcium	Dr. Reddy's Laboratories	Potency & Assay	Nationwide
25 Mar 2020Drug	CLASS II	Atorvastatin Calcium Tablets, USP 40 mg recalledAtorvastatin Calcium	Sun Pharmaceutical Industries	Foreign Material	Nationwide
6 Nov 2019Drug	CLASS III	Atorvastatin Calcium Tablets, USP 40 mg* recalled by ApotexAtorvastatin Calcium	Apotex	Other	5 states
22 Aug 2018Drug	CLASS III	Atorvastatin Calcium tablets, 40 mg recalled by Dr. Reddy's LaboratoriesAtorvastatin Calcium	Dr. Reddy's Laboratories	Potency & Assay	Nationwide
27 Jun 2018Drug	CLASS III	Atorvastatin Calcium Tablets, 10 mg* recalledAtorvastatin Calcium	Dr. Reddy's Laboratories	Potency & Assay	Nationwide
27 Jun 2018Drug	CLASS II	Atorvastatin Calcium Tablets, 80 mg* recalledAtorvastatin Calcium	Dr. Reddy's Laboratories	Foreign Material	Nationwide
27 Jun 2018Drug	CLASS III	Atorvastatin Calcium Tablets, 20 mg* recalledAtorvastatin Calcium	Dr. Reddy's Laboratories	Potency & Assay	Nationwide
27 Jun 2018Drug	CLASS III	Atorvastatin Calcium Tablets, 40 mg*, packaged as a) bottle recalledAtorvastatin Calcium	Dr. Reddy's Laboratories	Potency & Assay	Nationwide
7 Feb 2018Drug	CLASS III	Atorvastatin Calcium Tablets 20 mg, a) and b) recalledAtorvastatin Calcium	Dr. Reddy's Laboratories	Potency & Assay	Nationwide
7 Feb 2018Drug	CLASS III	Atorvastatin Calcium Tablets 40 mg recalled by Dr. Reddy's LaboratoriesAtorvastatin Calcium	Dr. Reddy's Laboratories	Potency & Assay	Nationwide
7 Feb 2018Drug	CLASS III	Atorvastatin Calcium Tablets 10 mg, a) and b) recalledAtorvastatin Calcium	Dr. Reddy's Laboratories	Potency & Assay	Nationwide
5 Apr 2017Drug	CLASS II	Atorvastatin Calcium Tablets, 80 mg* recalled by Mylan PharmaceuticalsAtorvastatin Calcium	Mylan Pharmaceuticals	Sterility	Nationwide
5 Apr 2017Drug	CLASS II	Atorvastatin Calcium Tablets, 20 mg* recalled by Mylan PharmaceuticalsAtorvastatin Calcium	Mylan Pharmaceuticals	Sterility	Nationwide
5 Apr 2017Drug	CLASS II	Atorvastatin Calcium Tablets, 10 mg* Unit Dose Tablets (10 recalledAtorvastatin Calcium	Mylan Institutional, Inc. (d.b.a. UDL Laboratories)	Sterility	Nationwide
5 Apr 2017Drug	CLASS II	Atorvastatin Calcium Tablets, 40 mg* recalled by Mylan PharmaceuticalsAtorvastatin Calcium	Mylan Pharmaceuticals	Sterility	Nationwide
5 Apr 2017Drug	CLASS II	Atorvastatin Calcium Tablets, 10 mg* recalled by Mylan PharmaceuticalsAtorvastatin Calcium	Mylan Pharmaceuticals	Sterility	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.