Medications & Supplements/Prescription Drugs

Dr. Reddy's Laboratories, Inc.: Atorvastatin Calcium Tablets Recalled for Impurities and Degradation

Agency Publication Date: June 21, 2018

Summary

Dr. Reddy's Laboratories is recalling approximately 230,101 bottles of Lipitor (atorvastatin calcium) tablets because the medicine failed to meet quality specifications for impurities and degradation. This recall affects the 10 mg, 20 mg, and 40 mg strength tablets distributed in 90-count and 500-count bottles throughout the United States and Puerto Rico. Because this is a medication for high cholesterol, patients should speak with their doctor or pharmacist before stopping use.

Risk

The tablets may contain higher than allowed levels of impurities or may have degraded over time, which can reduce the effectiveness of the medication or potentially expose consumers to unintended substances.

What You Should Do

Check your prescription bottle's label for Atorvastatin Calcium Tablets (10 mg, 20 mg, or 40 mg) and verify if the NDC number matches 55111-121-90, 55111-122-90, 55111-123-90, or 55111-123-05.
Identify if your bottle is from the affected lots: For 10 mg tablets, look for T600327 (Exp 07/18), T700213 (Exp 04/19), or T700215 (Exp 04/19). For 20 mg tablets, look for T600328 (Exp 07/18), T700214 (Exp 04/19), or T700216 (Exp 04/19).
For 40 mg tablets (90-count), check for lots T600392, T600384, T600353 (Exp 08/18); T600427 (Exp 09/18); T600435 (Exp 10/18); T600492 (Exp 11/18); or T700006, T700014, T700033, T700035, T700036 (Exp 12/18). For 40 mg (500-count), check for lot T600407 (Exp 09/18).
Contact your healthcare provider or pharmacist immediately to discuss if you should continue your current dose or switch to a replacement medication.
Return any unused tablets from the affected lots to the pharmacy where you purchased them for a refund.
For additional questions or to report adverse events, contact the FDA Consumer Complaint line at 1-888-723-3332 or visit www.fda.gov/safety/recalls.

Your Remedy Options

Full Refund

Contact your healthcare provider or pharmacist for guidance. Return any unused product to the pharmacy for a refund

How to: Contact your healthcare provider or pharmacist for guidance. Return any unused product to the pharmacy for a refund

Affected Products

Product: Atorvastatin Calcium Tablets, 10 mg (90-count bottle)

Model:

NDC 55111-121-90

Lot Numbers:

T600327 (Exp 07/18)

T700213 (Exp 04/19)

T700215 (Exp 04/19)

Date Ranges: Exp 07/18, Exp 04/19

Product: Atorvastatin Calcium Tablets, 20 mg (90-count bottle)

Model:

NDC 55111-122-90

Lot Numbers:

T600328 (Exp 07/18)

T700214 (Exp 04/19)

T700216 (Exp 04/19)

Date Ranges: Exp 07/18, Exp 04/19

Product: Atorvastatin Calcium Tablets, 40 mg (90-count bottle)

Model:

NDC 55111-123-90

Lot Numbers:

T600392 (Exp 08/18)

T600384 (Exp 08/18)

T600353 (Exp 08/18)

T600427 (Exp 09/18)

T600435 (Exp 10/18)

T600492 (Exp 11/18)

T700006 (Exp 12/18)

T700014 (Exp 12/18)

T700033 (Exp 12/18)

T700035 (Exp 12/18)

T700036 (Exp 12/18)

Date Ranges: Exp 08/18, Exp 09/18, Exp 10/18, Exp 11/18, Exp 12/18

Product: Atorvastatin Calcium Tablets, 40 mg (500-count bottle)

Model:

NDC 55111-123-05

Lot Numbers:

T600407 (Exp 09/18)

Date Ranges: Exp 09/18

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 80275

Status: Resolved

Manufacturer: Dr. Reddy's Laboratories, Inc.

Sold By: Pharmacies

Manufactured In: India, United States

Units Affected: 3 products (55,126 bottles; 44,894 bottles; 130,081 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

Check your prescription bottle's label for Atorvastatin Calcium Tablets (10 mg, 20 mg, or 40 mg) and verify if the NDC number matches 55111-121-90, 55111-122-90, 55111-123-90, or 55111-123-05.

Identify if your bottle is from the affected lots: For 10 mg tablets, look for T600327 (Exp 07/18), T700213 (Exp 04/19), or T700215 (Exp 04/19). For 20 mg tablets, look for T600328 (Exp 07/18), T700214 (Exp 04/19), or T700216 (Exp 04/19).

For 40 mg tablets (90-count), check for lots T600392, T600384, T600353 (Exp 08/18); T600427 (Exp 09/18); T600435 (Exp 10/18); T600492 (Exp 11/18); or T700006, T700014, T700033, T700035, T700036 (Exp 12/18). For 40 mg (500-count), check for lot T600407 (Exp 09/18).

Contact your healthcare provider or pharmacist immediately to discuss if you should continue your current dose or switch to a replacement medication.

Return any unused tablets from the affected lots to the pharmacy where you purchased them for a refund.

For additional questions or to report adverse events, contact the FDA Consumer Complaint line at 1-888-723-3332 or visit www.fda.gov/safety/recalls.

Affected Products

Product: Atorvastatin Calcium Tablets, 10 mg (90-count bottle)

Model:

NDC 55111-121-90

Lot Numbers:

T600327 (Exp 07/18)

T700213 (Exp 04/19)

T700215 (Exp 04/19)

Date Ranges: Exp 07/18, Exp 04/19

Product: Atorvastatin Calcium Tablets, 20 mg (90-count bottle)

Model:

NDC 55111-122-90

Lot Numbers:

T600328 (Exp 07/18)

T700214 (Exp 04/19)

T700216 (Exp 04/19)

Date Ranges: Exp 07/18, Exp 04/19

Product: Atorvastatin Calcium Tablets, 40 mg (90-count bottle)

Model:

NDC 55111-123-90

Lot Numbers:

T600392 (Exp 08/18)

T600384 (Exp 08/18)

T600353 (Exp 08/18)

T600427 (Exp 09/18)

T600435 (Exp 10/18)

T600492 (Exp 11/18)

T700006 (Exp 12/18)

T700014 (Exp 12/18)

T700033 (Exp 12/18)

T700035 (Exp 12/18)

T700036 (Exp 12/18)

Date Ranges: Exp 08/18, Exp 09/18, Exp 10/18, Exp 11/18, Exp 12/18

Product: Atorvastatin Calcium Tablets, 40 mg (500-count bottle)

Model:

NDC 55111-123-05

Lot Numbers:

T600407 (Exp 09/18)

Date Ranges: Exp 09/18