FDA Recall Zoloft

View Recall Number, Date, Reasons, Quantity

FDA Recall Enforcement Reports

The last Recall Enforcement Report for Zoloft with NDC 0049-4960 was initiated on 10-20-2017 as a Class II recall due to superpotent: weight variations resulting in tablets that are sub and super potent The latest recall number for this product is D-0151-2018 and the recall is currently terminated as of 06-02-2020 .

Recall Number Initiation Date Report Date Recall Classification Product Quantity Product Description Status
D-0151-201810-20-201701-10-2018Class II1972 bottlesZoloft (sertraline HCl) tablets 25 mg* 30-count bottle, Rx only, Distributed by Roerig Division of Pfizer Inc., NY, NY, 10017 NDC 0049-4960-30Terminated
D-0857-201604-28-201606-01-2016Class II68, 214 bottlesZoloft (sertraline HCl) tablets, 100 mg*, 30 count bottles, Rx only, Distributed by Roerig, Division of Pfizer, Inc., NY NY 10017, NDC 0049-4910-30.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.