FDA Recall Tadalafil
View Recall Number, Date, Reasons, Quantity
FDA Recall Enforcement Reports
The last Recall Enforcement Report for Tadalafil with NDC 16714-076 was initiated on 10-25-2021 as a Class II recall due to incorrect product formulation: an incorrect grade of crospovidone was used to manufacture the product. The latest recall number for this product is D-0230-2022 and the recall is currently terminated as of 09-01-2022 .
| Recall Number | Initiation Date | Report Date | Recall Classification | Product Quantity | Product Description | Status |
|---|---|---|---|---|---|---|
| D-0230-2022 | 10-25-2021 | 11-17-2021 | Class II | 73,957 30-count bottles | Tadalafil Tablets, USP 5 mg, 30 count bottle, Rx Only, Manufactured for: Northstar Rx LLC Memphis, TN 38141, Manufactured by: Sun Pharmaceutical Industries Limited, India, NDC # 16714-075-01 | Terminated |
| D-0231-2022 | 10-25-2021 | 11-17-2021 | Class II | 36,786 30-count bottles | Tadalafil Tablets, USP 20 mg, 30 count bottle, Rx Only, Manufactured for: Northstar Rx LLC Memphis, TN 38141, Manufactured by: Sun Pharmaceutical Industries Limited, India, NDC # 16714-077-01 | 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.