Zoloft — Class II drug recall D-0857-2016
Terminated recall by Pfizer Inc., reported 2016-06-01, distributed nationwide. Failed Tablet/Capsule Specifications: thick tablets exceeding specifications were found.
| Recall number | D-0857-2016 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Pfizer Inc., New York, NY, United States |
| Recall initiated | 2016-04-28 |
| Classified | 2016-05-20 |
| Reported by FDA | 2016-06-01 |
| Terminated | 2017-07-26 |
| Distributed | Nationwide (US) |
| NDC | 00049-4910-30 |
| Lot numbers | 08/18, M25569 |
Product
Zoloft (sertraline HCl) tablets, 100 mg*, 30 count bottles, Rx only, Distributed by Roerig, Division of Pfizer, Inc., NY NY 10017, NDC 0049-4910-30.
Reason for recall
Failed Tablet/Capsule Specifications: thick tablets exceeding specifications were found.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0857-2016. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.