Pfizer Inc. recalls Zoloft (sertraline HCl) tablets 25 mg* 30-count bottle, Rx only, Distributed by Roerig Division of Pfizer Inc., NY, NY,
Pfizer recalls Zoloft 25mg tablets due to weight variations causing subpotent or superpotent tablets. This may affect prescription medication safety. Check your NDC 0049-4960-30 lot S84026.
Lower-risk recall
SUPERPOTENT: Weight variations resulting in tablets that are sub and super potent
Contact the company & request your remedy
What happened, in plain English
Pfizer is recalling Zoloft 25mg tablets because some tablets may have weight variations that make them too weak or too strong. This could lead to incorrect dosing and potential health risks if taken without proper medical guidance. Read more at govinfonow.com/recall/41122-pfizer-zoloft-25mg-tablets-recall-weight-variations-risk-sub-super.
Source Summary by GovInfoNow · govinfonow.com/recall/41122-pfizer-zoloft-25mg-tablets-recall-weight-variations-risk-sub-super · Updated October 7, 2026 · FDA enforcement record: FDA #D-0151-2018
Cite this page
“Pfizer Zoloft 25mg Tablets Recall: Weight Variations Risk Sub/Super Potency.” GovInfoNow, updated October 7, 2026. https://govinfonow.com/recall/41122-pfizer-zoloft-25mg-tablets-recall-weight-variations-risk-sub-super. Based on FDA recall #D-0151-2018 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0151-2018%22&limit=1).
Why it’s dangerous
Weight variations in the tablets can cause some doses to be too weak (subpotent) or too strong (superpotent). This means patients might receive incorrect medication amounts, potentially leading to ineffective treatment or adverse effects.
Who’s affected
Prescription patients who have received the specific Zoloft 25mg 30-count bottle with NDC 0049-4960-30 lot S84026. Those with a history of severe side effects from SSRIs may be at higher risk.
How to tell if you have this one
Check for the Zoloft 25mg 30-count bottle with NDC code 0049-4960-30 and lot number S84026. This product was distributed by Pfizer's Roerig division and sold through prescription only.
- Brand
Pfizer- Category
Drug
All 2 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Status
Terminated- Distribution
Nationwide in the USA
| Recall number | Product, codes & lots | Quantity | Class | NDC |
|---|---|---|---|---|
| D-0150-2018 | diphenoxylate hydrochloride and atropine sulfate tablets, USP, 2.5 mg/0.025 mg, a) 100-count bottle (NDC 59762-1061-1), b) 1000-count bottle (NDC 59762-1061-2), Rx Only, Distributed by: Greenstone LLC. Peapack, NJ 07977; Lots: a) R83962, R93347, R93348, R93349, R93350, R93351, R93352, Exp. 2021 OCT 31; S57831, S57832, S57834, Exp. 2021 NOV 30 b) R93356, R93357, R93358, R97310, Exp. 2021 OCT 31. | 183437 bottles | Class I | 59762-1061-1, 59762-1061-2 |
| 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 0049-4960-30; Lot: S84026 | 1972 bottles | Class II | — |
What to do — step by step
Check Your Medication
Verify if your Zoloft tablets have the NDC 0049-4960-30 and lot number S84026.
Questions people ask
Is this recall affecting all Zoloft tablets?
No, this recall specifically affects Zoloft 25mg 30-count bottles with NDC 0049-4960-30 and lot S84026.
What should I do if I have the recalled tablets?
The recall record does not specify a remedy, so contact your healthcare provider for guidance on next steps.
Can I still take the recalled Zoloft tablets?
The recall record does not specify a remedy, so contact your healthcare provider for guidance on next steps.
Contact Pfizer
We’ve drafted a message you can send Pfizer to request your refund or repair — edit it as you like.
Subject: Recall D-0151-2018 — Pfizer Pfizer Hello, I own a Pfizer that is covered by recall D-0151-2018 from Pfizer. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #D-0151-2018 (October 20, 2017) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0151-2018 to see it in context.
- Plain-language summary written by qwen3:4b on October 7, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.