FDA Recall Esomeprazole Magnesium
View Recall Number, Date, Reasons, Quantity
FDA Recall Enforcement Reports
The last Recall Enforcement Report for Esomeprazole Magnesium with NDC 43598-509 was initiated on 04-24-2020 as a Class III recall due to discoloration: product contains brown pellets The latest recall number for this product is D-1256-2020 and the recall is currently terminated as of 05-13-2022 .
| Recall Number | Initiation Date | Report Date | Recall Classification | Product Quantity | Product Description | Status |
|---|---|---|---|---|---|---|
| D-1256-2020 | 04-24-2020 | 05-06-2020 | Class III | 1752 bottles | Esomeprazole Magnesium Delayed Release Capsules USP, 40 mg*, 1000-count bottles, Rx only, Mfd. By: Dr. Reddy's Laboratories Limited Bachupally - 500 090 INDIA, NDC 43598-510-10 | Terminated |
| D-0995-2019 | 02-06-2019 | 02-20-2019 | Class III | 40,592, 90 and 1,000 count bottles | Esomeprazole Magnesium Delayed-Release Capsules USP, 40mg*, a) 90-count bottle (NDC 43598-510-90) b) 1000 count bottle (NDC 43598-510-10), Rx only, Mfd By: Dr. Reddy's Laboratories Limited Bachupally - 500 090 INDIA. | Terminated |
What is the Enforcement Report?
All drug recalls are monitored by the Food and Drug Administration (FDA) and are included in the Enforcement Report once they are properly classified. The FDA will determine if a firm's removal or correction actions of a marked product meet the requirements to be considered a "recall". The FDA will also determine the public hazard assessment and a recall classification will be published in the Enforcement Report.