FlaggedRx← Medication recall checkHome
Class II · ModerateRecall completed

Zoloft

Could cause temporary or reversible harm; serious harm is unlikely.

Does this affect you?
Check your lot numberLot #: M25569, Exp 08/18
Where it was soldNationwide and Puerto Rico
Find the lot number printed on your box or bottle. If it matches — and you take this medicine — call your pharmacist. Don't stop a prescribed medicine on your own.

What happened

Failed Tablet/Capsule Specifications: thick tablets exceeding specifications were found.

What to do

  1. Check the lot number and expiry on your medicine against the recall above.
  2. Talk to your pharmacist or doctor before changing anything — don't stop on your own.
  3. Report any problems to FDA MedWatch (1-800-FDA-1088 or fda.gov/medwatch).

Who makes it

Made byROERIG
Brand nameZOLOFT
Generic nameSERTRALINE HYDROCHLORIDE
Active ingredient(s)SERTRALINE HYDROCHLORIDE
Distributed by / forRoerig, Division of Pfizer, Inc., NY NY 10017
NDC0049-4910-30
Show the full FDA record
Full product labelZoloft (sertraline HCl) tablets, 100 mg*, 30 count bottles, Rx only, Distributed by Roerig, Division of Pfizer, Inc., NY NY 10017, NDC 0049-4910-30.
Recalling firmPfizer Inc.
DistributionNationwide and Puerto Rico
Quantity68, 214 bottles
Recall initiated2016-04-28
Report date2016-06-01
Recall completed2017-07-26
Recall numberD-0857-2016
ClassificationClass II
FDA statusTerminated
Origin on fileNew York NY United States

Related

Recent drug recallsCheck another medication

Source: U.S. FDA enforcement database (openFDA). Look this up on the official FDA recalls site ↗

This is public FDA recall information, not medical advice. A recall does not always mean your specific bottle is affected. Never stop a prescribed medicine without asking your pharmacist or doctor.