FDA Recall Lansoprazole
View Recall Number, Date, Reasons, Quantity
FDA Recall Enforcement Reports
The last Recall Enforcement Report for Lansoprazole with NDC 55111-398 was initiated on 03-23-2022 as a Class II recall due to failed dissolution specifications; during long term stability testing. The latest recall number for this product is D-0738-2022 and the recall is currently terminated as of 02-02-2024 .
| Recall Number | Initiation Date | Report Date | Recall Classification | Product Quantity | Product Description | Status |
|---|---|---|---|---|---|---|
| D-0738-2022 | 03-23-2022 | 04-06-2022 | Class II | 7,703 bottles | Lansoprazole Delayed-Release Capsules, USP, 30 mg, 90-count bottle, Rx Only, Manufactured By: Dr. Reddy's Laboratories Limited, Bachupally - 500 090, India, NDC 55111-399-90. | Terminated |
| D-0737-2022 | 03-23-2022 | 04-06-2022 | Class II | 8,352 bottles (30-count), 1,368 bottles (90-count) | Lansoprazole Delayed-Release Capsules, USP, 15 mg, a) 30-count bottle, (NDC 55111-398-30), b) 90-count bottle, (55111-398-90), Rx Only, Manufactured. 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.