FDA Recall Tacrolimus
View Recall Number, Date, Reasons, Quantity
FDA Recall Enforcement Reports
The last Recall Enforcement Report for Tacrolimus with NDC 0378-2047 was initiated on 03-23-2020 as a Class III recall due to presence of foreign tablet/capsule - potential presence of commingled one tacrolimus 1 mg capsule in 5 mg bottles. The latest recall number for this product is D-1057-2020 and the recall is currently terminated as of 07-07-2021 .
| Recall Number | Initiation Date | Report Date | Recall Classification | Product Quantity | Product Description | Status |
|---|---|---|---|---|---|---|
| D-1057-2020 | 03-23-2020 | 04-01-2020 | Class III | 3,816 botlles | Tacrolimus Capsules, USP 5mg, 100-count bottle, Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV 26505, NDC 0378-2047-01 | Terminated |
| D-066-2013 | 06-29-2012 | 12-05-2012 | Class II | 15181 bottles. | Mylan, Tacrolimus Capsules 0.5 mg, 100 count bottle, Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV 26505 NDC 0378-2045-01 | 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.