Medications & Supplements/Prescription Drugs

Dr. Reddy's Atorvastatin Calcium Tablets Recalled for Failed Impurities

Agency Publication Date: March 29, 2022

Summary

Dr. Reddy's Laboratories, Inc. is recalling 28,068 bottles of Atorvastatin Calcium Tablets (80 mg), the generic equivalent of the cholesterol medication Lipitor. The recall was issued because testing revealed that some lots did not meet impurity and degradation specifications. No injuries or adverse health incidents have been reported to date.

Risk

The tablets may contain impurities or related substances that exceed approved safety limits. This defect could potentially impact the medication's quality and safety over time.

What You Should Do

The recalled products are 90-count bottles of Atorvastatin Calcium Tablets, USP 80 mg, sold under the Dr. Reddy's Laboratories brand (NDC 55111-124-90).
To identify if your medication is affected, check the lot number printed on the bottle. The affected lot numbers are T000707, T000756, T000758, T000759, T2100600, T2101075, and T2102802. See the Affected Products section below for the full list of affected codes.
If you have health concerns, contact your healthcare provider or pharmacist. Return any unused product to the place of purchase for a refund, throw it away, or contact Dr. Reddy's Laboratories, Inc. for further instructions.
Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional questions.

Your Remedy Options

You have 2 options:

Option 1: Full Refund

How to: Contact your healthcare provider or pharmacist for guidance, or return any unused product to the place of purchase for a refund

Option 2: Dispose of Product

How to: Throw the product away. For prescription medications, a DEA take-back location or pharmacy mail-back program is preferred when available.

Affected Products

Product: Atorvastatin Calcium Tablets, USP (80 mg)

Variants: 80 mg, 90 Tablets, Rx Only

Lot Numbers:

T000707 (Exp 03/2022)

T000756 (Exp 03/2022)

T000758 (Exp 03/2022)

T000759 (Exp 03/2022)

T2100600 (Exp 01/2023)

T2101075 (Exp 01/2023)

T2102802 (Exp 07/2023)

NDC:

55111-124-90

Recall #: D-0726-2022

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 89833

Status: Resolved

Manufacturer: Dr. Reddy's Laboratories, Inc.

Sold By: Pharmacies

Manufactured In: India, United States

Units Affected: 28,068 bottles

Distributed To: Nationwide

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Summary

What You Should Do

The recalled products are 90-count bottles of Atorvastatin Calcium Tablets, USP 80 mg, sold under the Dr. Reddy's Laboratories brand (NDC 55111-124-90).

To identify if your medication is affected, check the lot number printed on the bottle. The affected lot numbers are T000707, T000756, T000758, T000759, T2100600, T2101075, and T2102802. See the Affected Products section below for the full list of affected codes.

If you have health concerns, contact your healthcare provider or pharmacist. Return any unused product to the place of purchase for a refund, throw it away, or contact Dr. Reddy's Laboratories, Inc. for further instructions.

Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional questions.