FDA Recall Tretinoin
View Recall Number, Date, Reasons, Quantity
FDA Recall Enforcement Reports
The last Recall Enforcement Report for Tretinoin with NDC 0555-0808 was initiated on 06-14-2022 as a Class II recall due to failed dissolution specifications; low out of specification (oos) results for dissolution. The latest recall number for this product is D-1156-2022 and the recall is currently terminated as of 04-27-2023 .
| Recall Number | Initiation Date | Report Date | Recall Classification | Product Quantity | Product Description | Status |
|---|---|---|---|---|---|---|
| D-1156-2022 | 06-14-2022 | 06-29-2022 | Class II | 4941 bottles | Tretinoin Capsules, 10 mg, Rx Only, 100 capsules per bottle, Teva Pharmaceuticals USA Inc., North Wales, PA, 19454, NDC 0555-0808-02. | Terminated |
| D-0520-2022 | 01-10-2022 | 02-09-2022 | Class II | 1,175 Bottles | Tretinoin Capsules, 10 mg, 100 count bottle, Rx Only, Teva Pharmaceuticals USA, Inc., North Wales, PA 19454, NDC 0555-0808-02 | 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.