Dr. Reddy's Laboratories Atorvstatin Calcium Tablets Recall

Why it was recalled

Failed Impurities/Degradation Specifications: Out of Specification results for related substance.

Product description

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

Lot numbers, UPCs & expiration codes

Lot: T000707, T000756, T000758, T000759, Exp 03/2022; T2100600, T2101075, Exp. 1/2023; T2102802, Exp. 07/2023

Where it was sold

Nationwide in the USA.

What to do if you have this product

Compare the lot number and expiration date on your package with the codes above.
Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
If you have symptoms you think are related, contact your doctor. In an emergency call 911.
Report side effects to FDA MedWatch at 1-800-FDA-1088.

Recall details

Recall number: D-0726-2022
Classification: Class III
Status: Terminated
Recall initiated: Mar 16, 2022
FDA report date: Apr 6, 2022
Quantity: 28,068 bottles
Recall type: Voluntary: Firm initiated
Recalling firm: Dr. Reddy's Laboratories, Inc.

Original FDA data

Every field from FDA enforcement report D-0726-2022, exactly as published.

Show all FDA fields

City: Princeton
State: NJ
Status: Terminated
Country: United States
Event ID: 89833
Address: 107 College Rd E
Code information: Lot: T000707, T000756, T000758, T000759, Exp 03/2022; T2100600, T2101075, Exp. 1/2023; T2102802, Exp. 07/2023
Postal code: 08540-6623
Report date: Apr 6, 2022
Product type: Drugs
Recall number: D-0726-2022
Classification: Class III
Recalling firm: Dr. Reddy's Laboratories, Inc.
Product quantity: 28,068 bottles
Termination date: Nov 13, 2023
Reason for recall: Failed Impurities/Degradation Specifications: Out of Specification results for related substance.
Voluntary / mandated: Voluntary: Firm initiated
Product description: 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
Distribution pattern: Nationwide in the USA.
Recall initiation date: Mar 16, 2022
Initial firm notification: Letter
Center classification date: Mar 29, 2022

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-0726-2022, published Apr 6, 2022. View the source record (openFDA) · FDA enforcement reports

Last checked against FDA data: Oct 2, 2026. Content last changed: Oct 2, 2026.

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