FDA Recall Lansoprazole
View Recall Number, Date, Reasons, Quantity
FDA Recall Enforcement Reports
The last Recall Enforcement Report for Lansoprazole with NDC 68382-771 was initiated on 12-03-2020 as a Class II recall due to failed dissolution specifications The latest recall number for this product is D-0146-2021 and the recall is currently terminated as of 12-20-2022 .
| Recall Number | Initiation Date | Report Date | Recall Classification | Product Quantity | Product Description | Status |
|---|---|---|---|---|---|---|
| D-0146-2021 | 12-03-2020 | 12-23-2020 | Class II | 22,848 cartons | Lansoprazole Delayed-Release Orally Disintegrating Tablets, 30 mg, 100 Tablets (10 x 10 unit-dose) blister pack, Rx only, Manufactured by: Cadila Healthcare Ltd. Ahmedabad, India Distributed by: Zydus Pharmaceuticals USA Inc. Pennington, NJ 08534 NDC 68382-772-77 | Terminated |
| D-0145-2021 | 12-03-2020 | 12-23-2020 | Class II | 15,144 cartons | Lansoprazole Delayed-Release Orally Disintegrating Tablets 15 mg, 100 Tablets (10x10 unit dose) blister pack, Rx only, Manufactured by: Cadila Healthcare Ltd. Ahmedabad, India Distributed by: Zydus Pharmaceuticals USA Inc. Pennington, NJ 08534 NDC 68382-771-77 | Terminated |
| D-0075-2021 | 10-27-2020 | 11-11-2020 | Class II | 7,908 units | Lansoprazole Delayed-Release Orally Disintegrating Tablets 30 mg, 100-count carton (10 x10 unit-dose), Rx only, Manufactured by: Cadila Healthcare Ltd. Ahmedabad, India, Distributed by: Zydus Pharmaceuticals USA Inc. Pennington, NJ 08534, NDC 68382-772-77 | Terminated |
| D-0074-2021 | 10-27-2020 | 11-11-2020 | Class II | 6,840 units | Lansoprazole Delayed-Release Orally Disintegrating Tablets 15 mg, 100-count carton (10 x10 unit-dose), Rx only, Manufactured by: Cadila Healthcare Ltd. Ahmedabad, India, Distributed by: Zydus Pharmaceuticals USA Inc. Pennington, NJ 08534, NDC 68382-771-77 | 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.