Pfizer Recalls Zoloft 100 mg Tablets Due to Thick Tablet Issues
Pfizer is recalling specific lots of Zoloft (sertraline HCl) 100 mg tablets because they failed specifications for tablet thickness. Check your bottle's lot number.
Lower-risk recall
Failed Tablet/Capsule Specifications: thick tablets exceeding specifications were found.
Contact the company
What happened, in plain English
Pfizer Inc. has recalled Zoloft (sertraline HCl) tablets, 100 mg, in 30-count bottles distributed by Roerig. The recall was initiated because the thick tablets exceeded established specifications. This issue affects specific lots distributed nationwide and in Puerto Rico. Read more at govinfonow.com/recall/42857-pfizer-recalls-zoloft-100-mg-tablets-due-to-thick-tablet.
Source Summary by GovInfoNow · govinfonow.com/recall/42857-pfizer-recalls-zoloft-100-mg-tablets-due-to-thick-tablet · Updated October 9, 2026 · FDA enforcement record: FDA #D-0857-2016
Cite this page
“Pfizer Recalls Zoloft 100 mg Tablets Due to Thick Tablet Issues.” GovInfoNow, updated October 9, 2026. https://govinfonow.com/recall/42857-pfizer-recalls-zoloft-100-mg-tablets-due-to-thick-tablet. Based on FDA recall #D-0857-2016 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0857-2016%22&limit=1).
Why it’s dangerous
The recalled tablets failed specifications because they were found to be thicker than allowed. While this deviation from quality standards is noted, the record does not describe any specific health hazard or injury mechanism associated with the thickness.
Who’s affected
Individuals who have been prescribed Zoloft (sertraline HCl) 100 mg tablets from the affected distribution period are likely to have this product. The recall is limited to specific lot numbers, so not all users of the medication are affected.
How to tell if you have this one
Look for Zoloft (sertraline HCl) tablets, 100 mg, in 30-count bottles marked Rx only. Check the bottle for NDC 0049-4910-30 and Lot # M25569 with an expiration date of 08/18. The product was distributed by Roerig, Division of Pfizer, Inc., in NY.
- Brand
Pfizer- Category
Drug
What to do — step by step
Check Your Bottle
Verify if your Zoloft bottle matches NDC 0049-4910-30 and Lot # M25569 with Exp 08/18.
Contact Your Pharmacist
If you have the recalled lot, contact your pharmacist or Pfizer for further instructions on return or replacement.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “Nationwide and Puerto Rico” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 15 months after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
Questions people ask
What is the NDC number for the recalled product?
The National Drug Code (NDC) for the recalled bottles is 0049-4910-30.
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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-0857-2016 (April 28, 2016) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0857-2016 to see it in context.
- Plain-language summary written by qwen3.6:35b-a3b on October 9, 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.