Quick answers
- What is Atorvastatin used for?
- The FDA-approved label (Lipitor, Viatris Specialty LLC, April 15, 2024) says: “LIPITOR is indicated: • To reduce the risk of: o Myocardial infarction (MI), stroke, revascularization procedures, and angina in adults with multiple risk factors for coronary heart disease (CHD) but without clinically evident CHD o MI and stroke in adults with type 2 diabetes mellitus with multiple risk factors for CHD but without clinically evident CHD o Non-fatal MI, fatal and non-fatal stroke, revascularization …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Atorvastatin have a boxed warning?
- No. None of the 238 FDA labels we found for this medicine has a boxed warning.
- Is there a shortage of Atorvastatin?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Atorvastatin been recalled?
- FDA enforcement reports list 29 recalls of products of this medicine; the newest started September 19, 2025 (Class II). A recall usually concerns specific lots, not every product.
- Who makes Atorvastatin?
- 57 companies list prescription products of Atorvastatin in the FDA NDC Directory, including A-S Medication Solutions, NuCare Pharmaceuticals, Inc. and Bryant Ranch Prepack.
What Atorvastatin is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
LIPITOR is indicated: • To reduce the risk of: o Myocardial infarction (MI), stroke, revascularization procedures, and angina in adults with multiple risk factors for coronary heart disease (CHD) but without clinically evident CHD o MI and stroke in adults with type 2 diabetes mellitus with multiple risk factors for CHD but without clinically evident CHD o Non-fatal MI, fatal and non-fatal stroke, revascularization …
— FDA label: Lipitor, Viatris Specialty LLC, effective April 15, 2024. Read the full label on DailyMed →
The FDA has 238 labels for products of this medicine (different makers and forms); uses can differ between them. Check the label that comes with your own medicine.
This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Conditions named on the label
These condition names appear word for word in the label’s “Indications and Usage” text (matched with a reviewed table). Each page lists hospitals whose own websites name the condition.
Related medical specialties
Boxed warning
A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.
The label quoted above has no boxed warning.
0 of 238 FDA labels for this medicine have a boxed warning.
Forms and how it is given
| Dosage forms | Tablet, film coated · Tablet · Tablet, coated · Suspension |
|---|---|
| Route | Oral |
| Prescription products | 394 in the FDA NDC Directory |
| Brand names | Lipitor |
What pharmacies pay (NADAC)
The National Average Drug Acquisition Cost (NADAC) is the average price U.S. retail pharmacies paid to buy one unit of a medicine (one tablet, one mL or one gram), from a monthly survey of pharmacy invoices by the Centers for Medicare & Medicaid Services (CMS). State Medicaid programs use it to pay pharmacies.
This is not the price you pay. What you pay depends on your insurance (copay or coinsurance), your pharmacy and any discounts, and pharmacies also charge for filling a prescription. Ask your pharmacist or your health plan what your price will be.
| Strength and form | Generic or brand | Pharmacies pay |
|---|---|---|
| atorvastatin 10 mg tablet | Generic | $0.0230 per tablet |
| atorvastatin 20 mg tablet | Generic | $0.0286 per tablet |
| atorvastatin 40 mg tablet | Generic | $0.0369 per tablet |
| atorvastatin 80 mg tablet | Generic | $0.0680 per tablet |
| atorvastatin calcium propylene glycol solvate 10 mg tablet, film coated | Generic | $0.0230 per tablet |
| atorvastatin calcium propylene glycol solvate 20 mg tablet, film coated | Generic | $0.0286 per tablet |
| atorvastatin calcium propylene glycol solvate 40 mg tablet, film coated | Generic | $0.0369 per tablet |
| atorvastatin calcium propylene glycol solvate 80 mg tablet, film coated | Generic | $0.0680 per tablet |
| atorvastatin calcium trihydrate 10 mg tablet | Generic | $0.0230 per tablet |
| atorvastatin calcium trihydrate 10 mg tablet, film coated | Generic | $0.0230 per tablet |
| atorvastatin calcium trihydrate 10 mg tablet, film coated | Brand: Lipitor | $13.42 per tablet |
| atorvastatin calcium trihydrate 20 mg tablet | Generic | $0.0286 per tablet |
| atorvastatin calcium trihydrate 20 mg tablet, film coated | Generic | $0.0286 per tablet |
| atorvastatin calcium trihydrate 20 mg tablet, film coated | Brand: Lipitor | $19.06 per tablet |
| atorvastatin calcium trihydrate 20 mg/5 mL suspension | Brand: Atorvaliq | $1.23 per mL |
| atorvastatin calcium trihydrate 40 mg tablet | Generic | $0.0369 per tablet |
| atorvastatin calcium trihydrate 40 mg tablet, film coated | Generic | $0.0369 per tablet |
| atorvastatin calcium trihydrate 40 mg tablet, film coated | Brand: Lipitor | $19.12 per tablet |
| atorvastatin calcium trihydrate 80 mg tablet | Generic | $0.0680 per tablet |
| atorvastatin calcium trihydrate 80 mg tablet, film coated | Generic | $0.0680 per tablet |
| atorvastatin calcium trihydrate 80 mg tablet, film coated | Brand: Lipitor | $19.04 per tablet |
NADAC list of November 4, 2026; these prices took effect between October 1, 2026 and October 21, 2026. Shown only where a package’s NDC code matches the NADAC list exactly, and only for that exact strength and form: nothing is averaged across strengths. Strengths and forms not listed here have no NADAC price.
Source: NADAC (National Average Drug Acquisition Cost) 2026, data.medicaid.gov (CMS) →
Companies that list this medicine
Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.
- A-S Medication Solutions42 products
- NuCare Pharmaceuticals, Inc.37 products
- Bryant Ranch Prepack36 products
- Remedyrepack Inc.19 products
- Proficient Rx LP16 products
- Coupler LLC12 products
- Cardinal Health 107, LLC10 products
- Preferred Pharmaceuticals Inc.10 products
- Northwind Health Company, LLC9 products
- NorthStar RxLLC8 products
- QPharma, Inc.8 products
- Dr. Reddy's Laboratories Inc.8 products
- Cipla USA Inc.8 products
- Direct_Rx7 products
- Aphena Pharma Solutions - Tennessee, LLC7 products
- St. Mary's Medical Park Pharmacy6 products
- PD-Rx Pharmaceuticals, Inc.6 products
- Novadoz Pharmaceuticals LLC4 products
- Quallent Pharmaceuticals Health LLC4 products
- Accord Healthcare Inc.4 products
- Camber Pharmaceuticals, Inc.4 products
- Macleods Pharmaceuticals Limited4 products
- Laurus Labs Limited4 products
- Safecor Health LLC4 products
- ScieGen Pharmaceuticals, Inc.4 products
- Mylan Institutional Inc.4 products
- Dr. Reddy's Laboratories Limited4 products
- Lupin Pharmaceuticals, Inc.4 products
- Zydus Pharmaceuticals USA Inc.4 products
- Asclemed USA, Inc.4 products
- Rising Pharma Holdings, Inc.4 products
- Ascend Laboratories, LLC4 products
- Biocon Pharma Inc.4 products
- Lifestar Pharma LLC4 products
- Aurobindo Pharma Limited4 products
- Zydus Lifesciences Limited4 products
- Radha Pharmaceuticals, Inc.4 products
- Lepu Pharmaceutical Technology Co., Ltd.4 products
- Teva Pharmaceuticals USA, Inc.4 products
- Viatris Specialty LLC4 products
- Teva Pharmaceuticals, Inc.4 products
- Cadila Pharmaceuticals Limited4 products
- Mylan Pharmaceuticals Inc.4 products
- NCS HealthCare of KY, LLC dba Vangard Labs4 products
- Apotex Corp.4 products
- American Health Packaging4 products
- Major Pharmaceuticals4 products
- AvPAK4 products
- Quallent4 products
- Umedica Laboratories USA Inc.4 products
- Nivagen Pharmaceuticals, Inc.4 products
- NorthStar Rx LLC3 products
- Kesin Pharma Corporation2 products
- CMP Pharma, Inc.1 product
- Redpharm Drug1 product
- Unit Dose Solutions, Inc.1 product
- DirectRx1 product
FDA approval history
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
- ANDA: Abbreviated New Drug Application: how a generic version is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| NDA020702 LIPITOR | Upjohn | December 17, 1996 | 55, latest April 2, 2024 2024: Labeling · 2022: Labeling · 2020: Labeling |
| NDA213260 ATORVALIQ | Cmp Dev LLC | February 1, 2023 | 1, latest April 23, 2024 2024: Labeling |
Generic approvals (25)
- ANDA076477Sun Pharm Inds Ltd · November 30, 2011
- ANDA090548Apotex Inc · May 29, 2012
- ANDA091226Mylan Pharms Inc · May 29, 2012
- ANDA091650DR Reddys Labs Ltd · July 17, 2012
- ANDA202357DR Reddys Labs Ltd · July 17, 2012
- ANDA205519Sciegen Pharms · May 19, 2016
- ANDA205300Teva Pharms USA · March 27, 2017
- ANDA207687Accord Hlthcare · March 30, 2018
- ANDA209912Graviti Pharms · June 18, 2018
- ANDA206536Zydus Pharms · November 20, 2018
- ANDA209288Alkem Labs Ltd · December 21, 2018
- ANDA211933Msn · February 8, 2019
- ANDA204991Lupin · March 6, 2019
- ANDA205945Micro Labs Ltd India · November 7, 2019
- ANDA213853Umedica · August 19, 2020
- ANDA214659DR Reddys · July 14, 2021
- ANDA216848Lepu Pharm · November 3, 2022
- ANDA216436Biocon Pharma · November 23, 2022
- ANDA214344Hetero Labs Ltd V · September 12, 2023
- ANDA212103Cadila Pharms Ltd · October 16, 2023
- ANDA217081Mankind Pharma · January 5, 2024
- ANDA214513Laurus · January 22, 2024
- ANDA217118Aurobindo Pharma Ltd · February 13, 2024
- ANDA208480Macleods Pharms · June 3, 2024
- ANDA220276Teva Pharms Inc · November 13, 2025
Shortage status
The FDA drug shortage list does not show these products.
Recalls
From FDA enforcement reports, matched by the product’s NDC code. A recall usually covers specific lots only: check the lot number on your package and ask your pharmacist. Do not stop a medicine on your own.
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September 19, 2025 · Class II · Ongoing · D-0020-2026
Failed Dissolution Specifications
Atorvastatin Calcium Tablets USP, 80 mg, Rx Only, a). 90-count(NDC 67877-514-90), b). 500-count(NDC 67877-514-05), Manufactured by: Alkem Laboratories, Ltd. India, Distributed by: Ascend Laboratories, LLC, Parsippany, NJ — Ascend Laboratories, LLC
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September 19, 2025 · Class II · Ongoing · D-0017-2026
Failed Dissolution Specifications
Atorvastatin Calcium Tablets USP, 10 mg, Rx Only a) 90-count bottle (NDC 67877-511-90), b). 500-count bottle (NDC 67877-511-05), c). 1000-count bottle (NDC 67877-511-10) Manufactured by: Alkem Laboratories, Ltd. India, D — Ascend Laboratories, LLC
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September 19, 2025 · Class II · Ongoing · D-0018-2026
Failed Dissolution Specifications
Atorvastatin Calcium Tablets USP, 40 mg, Rx Only, a). 90-count (NDC 67877-513-90), b). 500-count (NDC 67877-513-05), c). 1000-count (NDC 67877-513-10), Manufactured by: Alkem Laboratories, Ltd. India, Distributed by: Asc — Ascend Laboratories, LLC
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September 19, 2025 · Class II · Ongoing · D-0019-2026
Failed Dissolution Specifications
Atorvastatin Calcium Tablets USP, 20 mg, Rx Only, a). 90-count(NDC 67877-512-90), b). 500-count (NDC 67877-512-05), c). 1000-count(NDC 67877-512-10),Manufactured by: Alkem Laboratories, Ltd. India, Distributed by: Ascend — Ascend Laboratories, LLC
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March 17, 2025 · Class II · Ongoing · D-0306-2025
Failed dissolution specifications: lower than specifications
Atorvastatin Calcium Tablets USP 40 mg, 1000-count bottle, Rx Only, Manufactured for: Biocon Pharma Inc., Iselin, NJ 08830-3009 USA, Manufactured by: Recipharm Pharmaservices PVT, Ltd Bengaluru, INDIA -562-123, NDC 70377 — BIOCON PHARMA INC
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September 24, 2024 · Class II · Terminated · D-0001-2025
Presence 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.
Atorvastatin Calcium Tablets, USP, 40mg, Rx only, 1000 Tablets per bottle, Manufactured for: Nivagen Pharmaceuticals, Inc. Sacramento, CA 95827, USA, Manufactured by: Umedica Laboratories Pvt Ltd., Vapi Gujarat 396195, I — Nivagen Pharmaceuticals Inc
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March 16, 2023 · Class II · Ongoing · D-0548-2023
CGMP Deviations
Atorvastatin Calcium Tablets, USP, 10 mg, 30-count bottles, Rx Only, Repackaged By: Northwind Pharmaceuticals, Indianapolis, IN 46203. NDC 51655-946-52 — Northwind Pharmaceuticals LLC
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February 7, 2023 · Class II · Terminated · D-0371-2023
CGMP Deviations: recalling drug products following an FDA inspection.
Atorvastatin Calcium Tablets USP, 10 mg* Rx Only, Packaged as a) 90 Tablets NDC 16729-044-15 UPC 3 16729 04415 8; b) 1,000 Tablets NDC 16729-044-17 UPC 3 16729 04417 2; Manufactured for: Accord Healthcare, Inc., Durham, — Accord Healthcare, Inc.
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February 7, 2023 · Class II · Terminated · D-0373-2023
CGMP Deviations: recalling drug products following an FDA inspection.
Atorvastatin Calcium Tablets USP 40 mg* Rx Only, Packaged as a) 90 Tablets NDC 16729-046-15 UPC 3 16729 04615 2; b) 1,000 Tablets NDC 16729-046-17 UPC 3 16729 04617 6, Manufactured for: Accord Healthcare, Inc., Durham, N — Accord Healthcare, Inc.
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February 7, 2023 · Class II · Terminated · D-0372-2023
CGMP Deviations: recalling drug products following an FDA inspection.
Atorvastatin Calcium Tablets USP 20 mg* Rx Only, Packaged as a) 90 Tablets NDC 16729-045-15 UPC 3 16729 04515 5; b) 1,000 Tablets NDC 16729-045-17 UPC 3 16729 04517 9, Manufactured for: Accord Healthcare, Inc., Durham, N — Accord Healthcare, Inc.
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February 7, 2023 · Class II · Terminated · D-0374-2023
CGMP Deviations: recalling drug products following an FDA inspection.
Atorvastatin Calcium Tablets USP 80 mg* Rx Only, Packaged as a) 90 Tablets NDC 16729-047-15 UPC 3 16729 04715 9; b) 500 Tablets NDC 16729-047-16 UPC 3 16729 04716 6; Manufactured for: Accord Healthcare, Inc., Durham, NC — Accord Healthcare, Inc.
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March 16, 2022 · Class III · Terminated · D-0726-2022
Failed Impurities/Degradation Specifications: Out of Specification results for related substance.
Atorvstatin Calcium Tablets, USP 80 mg*, 90 Tablets, Rx Only, Mrd. By: Dr. Reddy's Laboratories Limited, Srikakulam - 532 409, INDIA, NDC 55111-124-90 — Dr. Reddy's Laboratories, Inc.
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June 4, 2021 · Class III · Terminated · D-0629-2021
Failed Impurities/Degradation Specifications: due to presence of ATV cyclo IP and FP impurities
Atorvastatin Calcium Tablets, USP 10 mg, 500-count bottles, Rx Only, Dr. Reddy's Mfd. By: Dr. Reddy's Laboratories Limited, Bachupally, 500-090 India, NDC 55111-121-05. — Dr. Reddy's Laboratories, Inc.
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May 4, 2021 · Class III · Terminated · D-0599-2021
Failed Impurities -Degradation Specifications:due to presence of ATV cyclo IP and FP impurities
Atorvastatin Calcium Tablets, USP 10 mg*, Rx Only, 500 count bottle, Mfd By: Dr. Reddy's Laboratories Limited, Bachupally 500 090, India, NDC 55111-121-05. — Dr. Reddy's Laboratories, Inc.
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February 19, 2021 · Class III · Terminated · D-0291-2021
Failed Impurities/Degradation Specifications:presence of ATV cyclo IP and FP, Dihydroxy epoxy and Dieto epoxy impurities
Atorvastatin Calcium Tablets, 40mg, packaged in a) 90-count bottles, NDC 55111-123-90; b) 500-count bottles, NDC 55111-123-05; Rx only, Mfd By: Dr. Reddy's Laboratories Limited Srikakulam - 532 409 INDIA — Dr. Reddy's Laboratories, Inc.
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October 22, 2019 · Class III · Terminated · D-0153-2020
Presence of Foreign Tablets/Capsules: a single tablet of Pravastatin 40 mg found in bottle of Atorvastatin Calcium 40 mg.
Atorvastatin Calcium Tablets, USP 40 mg*, 1,000 count bottles, Rx Only, Manufactured by: Apotex Inc. Toronto, Ontario Canada M9L 1T9 Manufactured for: Apotex Corp. Weston, Florida 33326 NDC 60505-2580-8 — Apotex Inc.
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August 2, 2018 · Class III · Terminated · D-1079-2018
Failed Impurities/Degradation Specifications - OOS was observed for ATV Cyclo FP Impurity and Total Degradation Impurities tested at the 18 month stability time point in Atorvastatin Calcium Tablets 40 mg 500 tablets.
Atorvastatin Calcium tablets, 40 mg, 500-count bottle, Rx only, Mfd By: Dr. Reddy's Laboratories Limited, Srikakulam - 532 409 India, NDC 55111-123-05 — Dr. Reddy's Laboratories, Inc.
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June 12, 2018 · Class III · Terminated · D-0887-2018
Failed Impurities/Degradation Specifications
Atorvastatin Calcium Tablets, 20 mg*, 90-count bottle, Rx Only, Mfd. By: Dr. Reddy's Laboratories Limited, Srikakulam - 532 409 INDIA, NDC 55111-122-90 — Dr. Reddy's Laboratories, Inc.
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June 12, 2018 · Class III · Terminated · D-0886-2018
Failed Impurities/Degradation Specifications
Atorvastatin Calcium Tablets, 10 mg*, 90-count bottle, Rx Only, Mfd. By: Dr. Reddy's Laboratories Limited, Srikakulam - 532 409 INDIA, NDC 55111-121-90 — Dr. Reddy's Laboratories, Inc.
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June 12, 2018 · Class III · Terminated · D-0888-2018
Failed Impurities/Degradation Specifications
Atorvastatin Calcium Tablets, 40 mg*, packaged as a) 90-count bottle (NDC 55111-123-90 and b) 500-count bottle (NDC 55111-123-05), Rx Only, Mfd. By: Dr. Reddy's Laboratories Limited, Srikakulam - 532 409 INDIA — Dr. Reddy's Laboratories, Inc.
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May 30, 2018 · Class II · Terminated · D-0878-2018
Presence of Foreign Substance: A product complaint was received for a defective tablet with an embedded foreign object observed in a bottle.
Atorvastatin Calcium Tablets, 80 mg*, 90-count bottles, Rx Only, Mfd. By: Dr. Reddy's Laboratories Limited, Srikakulam - 532 409 INDIA, NDC 55111-124-90 UPC 355111124900 — Dr. Reddy's Laboratories, Inc.
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January 29, 2018 · Class III · Terminated · D-0418-2018
Failed Impurities/Degradations Specifications; out-of-specification results observed for Total Degradation Impurities during stability
Atorvastatin Calcium Tablets 10 mg, a) 90 count and b) 500 count bottles, Rx only, Mfd by: Dr. Reddy's Laboratories, Ltd., Srikakulam, INDIA --- NDC 55111-121-05 — Dr. Reddy's Laboratories, Inc.
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January 29, 2018 · Class III · Terminated · D-0419-2018
Failed Impurities/Degradations Specifications; out-of-specification results observed for Total Degradation Impurities during stability
Atorvastatin Calcium Tablets 20 mg, a) 90 count and b) 500 count bottles, Rx only, Mfd by: Dr. Reddy's Laboratories, Ltd., Srikakulam, INDIA --- NDC 55111-122-05 — Dr. Reddy's Laboratories, Inc.
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January 29, 2018 · Class III · Terminated · D-0420-2018
Failed Impurities/Degradations Specifications; out-of-specification results observed for Total Degradation Impurities during stability
Atorvastatin Calcium Tablets 40 mg, 90 count bottles, Rx only, Mfd by: Dr. Reddy's Laboratories, Ltd., Srikakulam, INDIA --- NDC 55111-123-05 — Dr. Reddy's Laboratories, Inc.
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March 21, 2017 · Class II · Terminated · D-0622-2017
Microbial Contamination of Non-Sterile Products: potential of an elevated bioburden with identification of objectionable organisms.
Atorvastatin Calcium Tablets, 10 mg*, 100-count Unit Dose Tablets (10 x 10) per carton, Rx only, Manufactured by: Mylan Pharmaceuticals Inc., Morgantown, WV 26505 U.S.A.., NDC 51079-208-20 — Mylan Institutional, Inc. (d.b.a. UDL Laboratories)
Showing the newest 25 of 29.
What do the recall classes mean?
Class I: The most serious type: there is a reasonable chance that using the product will cause serious health problems or death.
Class II: Using the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
Class III: Using the product is not likely to cause health problems (for example a labeling or packaging issue).
Official identifiers
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Lipitor, Viatris Specialty LLC, effective April 15, 2024; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →