---
title: "Atorvastatin Calcium Tablets USP 80 mg* Rx Only, Packaged as a) 90 Tablets ND... — FDA record D-0374-2023 | Is It on Recall"
description: "CGMP Deviations: recalling drug products following an FDA inspection."
url: https://isitonrecall.com/recall/fda-drug-d-0374-2023-atorvastatin-calcium-tablets-usp-80-mg-rx-only-packaged-as-a-90-tablets-ndc-16729-047-15-upc-3-16729/
updated: 2026-10-01
site: "Is It on Recall"
language: en
---

[Recall archive](https://isitonrecall.com/archives/) / FDA drug enforcement

# Atorvastatin Calcium Tablets USP 80 mg\* Rx Only, Packaged as a) 90 Tablets NDC 16729-047-15 UPC 3 16729 04715 9; b) 5... — FDA record D-0374-2023

Reported terminated

Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.

Source date Feb 7, 2023. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.

Archive changed Oct 1, 2026. USDA FSIS records are unavailable; [check FSIS directly](https://www.fsis.usda.gov/recalls). [Source coverage and dates](https://isitonrecall.com/sources/).

## What the record says

- **Product**: 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 27703 Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213, INDIA
- **Reason**: CGMP Deviations: recalling drug products following an FDA inspection.
- **Classification**: Class II
- **Recalling firm**: Accord Healthcare, Inc.
- **Quantity**: 72,376 bottles
- **Agency-reported status**: Terminated
- **Source record identifier**: D-0374-2023

[Open the official record](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0374-2023%22)

[What the recall classes mean](https://isitonrecall.com/guides/recall-classes/). Classification is an agency assessment, not individual medical advice.

## Lot and product identifiers

| Label field | Details supplied by the agency |
| --- | --- |
| Lot, code or applicability | Batches: a)R2100283, R2100288, R2100289, Exp. Date 2/28/2023; R2200235, Exp. Date 1/31/2024; R2201037, R2200952, Exp. Date 6/30/2024; b) R2100291, R2100281, R2100282, R2100292, R2100293, R2100294, R2100290, R2100306, R2100348, R2100349, R2100347, R2100350, R2100356, R2100355, Exp. Date 2/28/2023; R2100461, R2100463, R2100464, Exp. Date 3/31/2023; R2101214, R2101215, R2101216, Exp. Date 9/30/2023; R2101572, R2101573, R2101577, R2101578, R2101585, R2101579, R2101584, R2101587, R2101597, Exp. Date 11/30/2023; R2200801, Exp. Date 6/30/2024; |

Match all identifying details in the current notice. A brand name alone is not enough.

## Distribution

United States including Puerto Rico and Canada

No US distribution state could be established from this record. Check the official notice.

## Dates in the source

- **Report date**: Mar 8, 2023
- **Recall initiation date**: Feb 7, 2023
- **Center classification date**: Mar 2, 2023
- **Termination date**: Apr 22, 2024

FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.

## What to do next

Read the official notice for the action that applies to your exact product.

[Read the current instructions](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0374-2023%22)

## Before changing a medicine

Follow urgent instructions in the current official recall notice. Speak to your pharmacist or prescriber before stopping or changing a prescribed medicine.

Talk to your doctor or pharmacist if you have questions or concerns about your medicine. [FDA medication recall guidance](https://www.fda.gov/drugs/drug-recalls/understanding-drug-recalls-what-know-and-what-do)

## Related records

[Atorvastatin records](https://isitonrecall.com/drug/atorvastatin/) [Medications records](https://isitonrecall.com/category/medications/) [Accord Healthcare, Inc. records](https://isitonrecall.com/brand/accord-healthcare-inc/)