FDA Recall Atorvastatin Calcium
View Recall Number, Date, Reasons, Quantity
FDA Recall Enforcement Reports
The most recent Recall Enforcement Report that covers this product was initiated on March 9th, 2020 and classified as a Class II recall due to presence of foreign substance: foreign matter has been identified as latex glove in one lot of atorvastatin calcium tablets usp 40 mg. This recall is currently terminated, and the associated recall number is recall number is D-1047-2020. It pertains to Atorvastatin Calcium identified by 63304-827 as of 02-09-2021 .
| Recall Number | Recall Initiation Date | Report Date | Quantity | Product Description | Recall Reason | Status |
|---|---|---|---|---|---|---|
| D-1047-2020 | 03-09-2020 | 03-25-2020 | 1416 bottles | Atorvastatin Calcium Tablets, USP 40 mg, Rx only, 500-count bottle, Manufactured by: Sun Pharmaceutical Industries Limited Mohali, INDIA, Distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512, NDC 63304-829-05 | Presence of foreign substance: Foreign matter has been identified as latex glove in one lot of Atorvastatin Calcium Tablets USP 40 mg. | Terminated |
| D-1086-2014 | 01-16-2014 | 03-05-2014 | 64,626 bottles | Atorvastatin Calcium Tablets, 10 mg, 90-count tablets per bottle, Rx only, Manufactured for: Ranbaxy Pharmaceuticals Inc., Jacksonville, FL 32257 USA; by: Ranbaxy Laboratories Ltd., New Delhi -110 019, India; NDC 63304-827-90 | Presence of Foreign Tablets: A product complaint was received by a pharmacist who discovered an Atorvastatin 20 mg tablet inside a sealed bottle of 90-count Atorvastatin 10 mg. | Terminated |
| D-072-2013 | 11-09-2012 | 12-05-2012 | 157,026 Bottles | Atorvastatin Calcium Tablets, 40 mg, a) 90 tablets per bottle, b) 500 tablets per bottle, Rx only, Manufactured for: Ranbaxy Pharmaceuticals Inc., Jacksonville, FL 32257, USA, by: Ranbaxy Laboratories Ltd., New Delhi - 110019, India, NDC #: a) 63304-829-90, b) 63304-829-05. | Presence of Particulate Matter: Certain batches of Atorvastatin tablets 10 mg, 20 mg and 40 mg may contain small glass particulates. | Terminated |
| D-071-2013 | 11-09-2012 | 12-05-2012 | 203,198 Bottles | Atorvastatin Calcium Tablets, 20 mg, 90 tablets per bottle, Rx only, Manufactured for: Ranbaxy Pharmaceuticals Inc., Jacksonville, FL 32257, USA, by: Ranbaxy Laboratories Ltd., New Delhi - 110019, India, NDC #: 63304-828-90 | Presence of Particulate Matter: Certain batches of Atorvastatin tablets 10 mg, 20 mg and 40 mg may contain small glass particulates. | Terminated |
| D-070-2013 | 11-09-2012 | 12-05-2012 | 120,201 Bottles | Atorvastatin Calcium Tablets, 10 mg, 90 tablets per bottle, Rx only, Manufactured for: Ranbaxy Pharmaceuticals Inc., Jacksonville, FL 32257, USA, by: Ranbaxy Laboratories Ltd., New Delhi - 110019, India, NDC #: 63304-827-90 | Presence of Particulate Matter: Certain batches of Atorvastatin tablets 10 mg, 20 mg and 40 mg may contain small glass particulates. | Terminated |
| D-060-2013 | 08-21-2012 | 11-28-2012 | 32,208 bottles | Atorvastatin Calcium Tablets, 10 mg, 90-count tablets per bottle, Rx only, Manufactured for: Ranbaxy Pharmaceuticals Inc., Jacksonville, FL 32257 USA; by: Ranbaxy Laboratories Ltd., New Delhi -110 019, India; NDC 63304-827-90 | Adulterated Presence of Foreign Tablets: A product complaint was received by a pharmacist who discovered an Atorvastatin 20 mg tablet inside a sealed bottle of 90-count Atorvastatin 10 mg. | Terminated |
What is a Recall Enforcement Report?
A Recall Enforcement Report is an official publication by the FDA that documents all classified drug recalls.
When a company initiates a product removal or correction, the FDA evaluates whether the action meets the criteria for a recall. If it does, the FDA assesses the level of public health risk and assigns a recall classification (Class I, II, or III). Once classified, the recall is published in the Enforcement Report, which includes details such as the product name, affected lot numbers, reason for recall, and scope of distribution.
The Enforcement Report ensures transparency and allows the public and healthcare professionals to stay informed about products that may present a health or safety concern.
Understanding Recall Reports
The recall information provided on this website is sourced directly from official U.S. Food and Drug Administration (FDA) data. It is important to understand that most product recalls are limited in scope and typically involve only specific lots or batches of a product that have been identified as potentially defective or non-compliant with regulatory standards.
Recalls may be initiated voluntarily by the manufacturer or distributor, or they may be mandated by the FDA when a product is found to pose a health risk. A recall does not necessarily mean that all units of a product are unsafe.
If you have concerns about the safety of a medication or healthcare product you are using, it is strongly recommended that you verify the product’s lot number and consult your pharmacist or healthcare provider to determine whether your specific product is affected by the recall.
