FDA Recall Prednisone

View Recall Number, Date, Reasons, Quantity

FDA Recall Enforcement Reports

The last Recall Enforcement Report for Prednisone with NDC 0054-8740 was initiated on 10-03-2016 as a Class II recall due to failed tablet/capsule specifications: discovery of an underweight tablet. The latest recall number for this product is D-0008-2017 and the recall is currently terminated as of 12-18-2017 .

Recall Number Initiation Date Report Date Recall Classification Product Quantity Product Description Status
D-0008-201710-03-201610-12-2016Class II15,109 bottlesPredniSONE Tablets USP, 1 mg, 100-count bottles, Rx only, Distr. by: West-Ward Pharmaceuticals Corp., Eatontown, NJ 07724, NDC 0054-4741-25.Terminated
D-882-201306-14-201308-21-2013Class III14,619 cartonsPrednisone Tablet USP, 20 mg tablets, packaged in blisters of ten (10) tablets per blister card, ten blister cards per carton, Roxanne, Columbus, OH --- NDC 0054-0018-20Terminated

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.