RecallRadar

FDA Drug recall D-0151-2018

Zoloft (sertraline HCl) tablets 25 mg* 30-count bottle, Rx only, Distributed by Roerig Division of Pfizer Inc., NY, NY, 10017 NDC 0049-4960…

On 2018-01-10 the FDA classified a Class II recall of Zoloft (sertraline HCl) tablets 25 mg* 30-count bottle, Rx only, Distributed by Roerig Division of Pfizer Inc., NY, NY, 10017 NDC 0049-4960… by Pfizer, citing SUPERPOTENT: Weight variations resulting in tablets that are sub and super potent.

Read the official FDA Drug notice

AgencyFDA Drug
Recall numberD-0151-2018
ClassificationClass II
Statusterminated
Initiated2017-10-20
Published2018-01-10
Last updated2026-09-13 11:52 UTC
CompanyPfizer
DistributionUS

Product

Zoloft (sertraline HCl) tablets 25 mg* 30-count bottle, Rx only, Distributed by Roerig Division of Pfizer Inc., NY, NY, 10017 NDC 0049-4960-30

Reason

SUPERPOTENT: Weight variations resulting in tablets that are sub and super potent

Identifiers

code_infoLot: S84026

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0151-2018%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.