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Class II · ModerateRecall completed

Zoloft

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

Does this affect you?
Check your lot numberLot: S84026
Where it was soldNationwide in the USA
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

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

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
NDC0049-4960-30
Show the full FDA record
Full product labelZoloft (sertraline HCl) tablets 25 mg* 30-count bottle, Rx only, Distributed by Roerig Division of Pfizer Inc., NY, NY, 10017 NDC 0049-4960-30
Recalling firmPfizer Inc.
DistributionNationwide in the USA
Quantity1972 bottles
Recall initiated2017-10-20
Report date2018-01-10
Recall completed2020-06-02
Recall numberD-0151-2018
ClassificationClass II
FDA statusTerminated
Origin on fileNew York NY United States

Related

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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.