Atorvastatin recalls

The FDA has published 48 recalls involving Atorvastatin since 2012. The latest was reported on 22 Oct 2025. Most were for potency & assay. 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 recalls48since 2012

Last 12 months4reported

Class I00% of total

Ongoing8latest 22 Oct 2025

Recalls per month, last 24 months

click a bar for that month

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

Severity split

Class I 0 0%Class II 36 75%Class III 12 25%

Why atorvastatin is recalled

Companies

By year

2025510%
202412%
2023919%
202212%
202136%
202024%
201924%
2018817%
2017613%
2014715%

Ongoing atorvastatin recalls

8 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 recalls, newest first

48 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 recalled	Nivagen Pharmaceuticals	Other	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	Atorvastatin 20 mg tablets, packaged in a) 30-count bottles recalled	RemedyRepack	Manufacturing (CGMP) Deviations	Nationwide
12 Apr 2023Drug	CLASS II	Atorvastatin 10 mg tablets, packaged in a) 30-count bottles recalled	RemedyRepack	Manufacturing (CGMP) Deviations	Nationwide
12 Apr 2023Drug	CLASS II	Atorvastatin Calcium Tablets, USP, 20 mg recalled	Preferred Pharmaceuticals	Manufacturing (CGMP) Deviations	Nationwide
12 Apr 2023Drug	CLASS II	Atorvastatin Calcium Tablets, USP, 10 mg recalled	Preferred 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
12 Feb 2020Drug	CLASS II	Atorvastatin Calcium Tablets, USP, 10 mg* recalled	Graviti Pharmaceuticals Private	Other	Nationwide
6 Nov 2019Drug	CLASS III	Atorvastatin Calcium Tablets, USP 40 mg* recalled by ApotexAtorvastatin Calcium	Apotex	Other	5 states
31 Jul 2019Drug	CLASS II	Atorvastatin Calcium Tablet USP 80 mg, a) recalled	Ascend Laboratories	Potency & Assay	Nationwide
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

Should you stop taking Atorvastatin?

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.