Class III · Lower riskRecall completed
Atorvastatin Calcium
Unlikely to cause harm — often a labeling or packaging issue.
Does this affect you?
Check your lot numberLot #: a) T600392, T600384, T600353, Exp 08/18; T600427, Exp 09/18; T600435, Exp 10/18; T600492, Exp 11/18; T700006, T700014, T700033, T700035, T700036 12/18; b) T600407, Exp 09/18
Where it was soldNationwide in the USA and Puerto Rico
Find the lot number printed on your box or bottle. If it matches — and you take this medicine — call your pharmacist. Don't stop a prescribed medicine on your own.
What happened
Failed Impurities/Degradation Specifications
What to do
- Check the lot number and expiry on your medicine against the recall above.
- Talk to your pharmacist or doctor before changing anything — don't stop on your own.
- Report any problems to FDA MedWatch (1-800-FDA-1088 or fda.gov/medwatch).
Who makes it
Made byDr. Reddy's Laboratories Limited
| Brand name | ATORVASTATIN CALCIUM |
| Generic name | ATORVASTATIN CALCIUM |
| Active ingredient(s) | ATORVASTATIN CALCIUM TRIHYDRATE |
| Distributed by / for | Dr. Reddy's Laboratories, Inc. |
| NDC | 55111-123-90 |
Show the full FDA record
| Full product label | Atorvastatin Calcium Tablets, 40 mg*, packaged as a) 90-count bottle (NDC 55111-123-90 and b) 500-count bottle (NDC 55111-123-05), Rx Only, Mfd. By: Dr. Reddy's Laboratories Limited, Srikakulam - 532 409 INDIA |
| Recalling firm | Dr. Reddy's Laboratories, Inc. |
| Distribution | Nationwide in the USA and Puerto Rico |
| Quantity | 130,081 bottles |
| Recall initiated | 2018-06-12 |
| Report date | 2018-06-27 |
| Recall completed | 2019-11-08 |
| Recall number | D-0888-2018 |
| Classification | Class III |
| FDA status | Terminated |
| Origin on file | Princeton NJ United States |
Source: U.S. FDA enforcement database (openFDA). Look this up on the official FDA recalls site ↗
This is public FDA recall information, not medical advice. A recall does not always mean your specific bottle is affected. Never stop a prescribed medicine without asking your pharmacist or doctor.