CLASS II Drug recall · Reported 10 Jan 2018 · FDA Enforcement Report
Zoloft (sertraline HCl) tablets 25 mg* recalled by Pfizer
Pfizer is recalling Zoloft (sertraline HCl) tablets 25 mg*, distributed nationwide in the US. The recall was initiated on 20 Oct 2017 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0151-2018
- FDA event ID
- 78332
- Recalling firm
- Pfizer, New York, NY
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 20 Oct 2017
- FDA classified
- 4 Jan 2018
- Reported
- 10 Jan 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Drug class
- Antidepressants
Timeline
| 20 Oct 2017 | Recall initiated by company | |
| 4 Jan 2018 | Classified by FDA | +76 days |
| 10 Jan 2018 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
SUPERPOTENT: Weight variations resulting in tablets that are sub and super potent
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
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
Where it was distributed
Nationwide in the USA
Questions about this recall
Is Zoloft (sertraline HCl) tablets 25 mg* recalled?
Yes. Pfizer recalled Zoloft (sertraline HCl) tablets 25 mg* on 20 Oct 2017. The recall is Class II and its status is Terminated. Recall number D-0151-2018.
Why was it recalled?
SUPERPOTENT: Weight variations resulting in tablets that are sub and super potent
Which lots are affected?
Lot: S84026
Where was it sold?
Nationwide in the USA
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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