CLASS II Drug recall · Reported 8 Mar 2023 · FDA Enforcement Report

Atorvastatin Calcium Tablets USP 20 mg* recalled by Accord Healthcare

Accord Healthcare is recalling Atorvastatin Calcium Tablets USP 20 mg*, distributed in Puerto Rico. The recall was initiated on 7 Feb 2023 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesBatches: a)R2100305, Exp. Date 2/28/2023; R2200227, Exp. Date 1/31/2024; R2200797, Exp. Date 6/30/2024; b) R2101423, R2101438, R2101447, R2101446, Exp. Date 10/31/2023; R2200040, R2200041, R2200052, R2200043, R2200044, R2200051, R2200060, R2200061, R2200062, R2200077, R2200078, Exp. Date 12/31/2023; R2200228, R2200480, Exp. Date 1/31/2024; R2200266, R2200267, R2200265, R2200268, Exp. Date 2/29/2024; R2200370, Exp. Date 3/31/2024; R2201038, Exp. Date 6/30/2024;

NDC16729-044, 16729-045, 16729-046, 16729-047

UPC316729045155, 316729045179

Quantity recalled241,585 bottles

Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.

Recall details

Recall number: D-0372-2023
FDA event ID: 91657
Recalling firm: Accord Healthcare, Durham, NC
Brand: Atorvastatin Calcium
Manufacturer: Accord Healthcare Inc.
Classification: Class II
Status: Terminated
Recall initiated: 7 Feb 2023
FDA classified: 2 Mar 2023
Reported: 8 Mar 2023
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Manufacturing (CGMP) Deviations
Drug class: Cholesterol Medication

Timeline

7 Feb 2023	Recall initiated by company
2 Mar 2023	Classified by FDA	+23 days
8 Mar 2023	Published in enforcement report	+6 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

CGMP Deviations: recalling drug products following an FDA inspection.

Product as listed by the FDA

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, NC 27703 Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213, INDIA

Where it was distributed

United States including Puerto Rico and Canada

Puerto Rico

Questions about this recall

Is Atorvastatin Calcium Tablets USP 20 mg* recalled?

Yes. Accord Healthcare recalled Atorvastatin Calcium Tablets USP 20 mg* on 7 Feb 2023. The recall is Class II and its status is Terminated. Recall number D-0372-2023.

Why was it recalled?

CGMP Deviations: recalling drug products following an FDA inspection.

Which lots are affected?

Batches: a)R2100305, Exp. Date 2/28/2023; R2200227, Exp. Date 1/31/2024; R2200797, Exp. Date 6/30/2024; b) R2101423, R2101438, R2101447, R2101446, Exp. Date 10/31/2023; R2200040, R2200041, R2200052, R2200043, R2200044, R2200051, R2200060, R2200061, R2200062, R2200077, R2200078, Exp. Date 12/31/2023; R2200228, R2200480, Exp. Date 1/31/2024; R2200266, R2200267, R2200265, R2200268, Exp. Date 2/29/2024; R2200370, Exp. Date 3/31/2024; R2201038, Exp. Date 6/30/2024;

Where was it sold?

United States including Puerto Rico and Canada

What should I do if I have it?

Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

More recalls from Accord Healthcare

All 106

Reported	Class	Recall	Company	Reason	Where
2 Sep 2026Drug	CLASS II	Levothyroxine Sodium Tablets, USP, 112 mcg 112 mg) recalledLevothyroxine Sodium	Accord Healthcare	Potency & Assay	Nationwide
2 Sep 2026Drug	CLASS II	Levothyroxine Sodium Tablets, USP, 88 mcg 088 mg) recalledLevothyroxine Sodium	Accord Healthcare	Potency & Assay	Nationwide
2 Sep 2026Drug	CLASS II	Levothyroxine Sodium Tablets, USP, 100 mcg 1 mg) recalledLevothyroxine Sodium	Accord Healthcare	Potency & Assay	Nationwide
2 Sep 2026Drug	CLASS II	Levothyroxine Sodium Tablets, USP, 175 mcg 175 mg) recalledLevothyroxine Sodium	Accord Healthcare	Potency & Assay	Nationwide
2 Sep 2026Drug	CLASS II	Levothyroxine Sodium Tablets, USP, 150 mcg 15 mg) recalledLevothyroxine Sodium	Accord Healthcare	Potency & Assay	Nationwide

Other Atorvastatin recalls

All 40

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