Dr. Reddy's Laboratories Atorvastatin Calcium Tablets Recall

Why it was recalled

Failed Impurities/Degradation Specifications: due to presence of ATV cyclo IP and FP impurities

Product description

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.

Lot numbers, UPCs & expiration codes

Lot #: C905064, C905065, Exp. Date 07/2021

Where it was sold

Nationwide within the United States

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-0629-2021
Classification: Class III
Status: Terminated
Recall initiated: Jun 4, 2021
FDA report date: Jun 23, 2021
Quantity: 5984 bottles
Recall type: Voluntary: Firm initiated
Recalling firm: Dr. Reddy's Laboratories, Inc.

Original FDA data

Every field from FDA enforcement report D-0629-2021, exactly as published.

Show all FDA fields

City: Princeton
State: NJ
Status: Terminated
Country: United States
Event ID: 88041
Address: 107 College Rd E
Code information: Lot #: C905064, C905065, Exp. Date 07/2021
Postal code: 08540-6623
Report date: Jun 23, 2021
Product type: Drugs
Recall number: D-0629-2021
Classification: Class III
Recalling firm: Dr. Reddy's Laboratories, Inc.
Product quantity: 5984 bottles
Termination date: Feb 16, 2023
Reason for recall: Failed Impurities/Degradation Specifications: due to presence of ATV cyclo IP and FP impurities
Voluntary / mandated: Voluntary: Firm initiated
Product description: 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.
Distribution pattern: Nationwide within the United States
Recall initiation date: Jun 4, 2021
Initial firm notification: Letter
Center classification date: Jun 11, 2021

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-0629-2021, published Jun 23, 2021. View the source record (openFDA) · FDA enforcement reports

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

FindMyRecall is an independent service and is not affiliated with or endorsed by the FDA. This page simplifies the official record; the FDA or manufacturer notice is authoritative, so follow its instructions. Medication information here is not individualized medical advice.