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Lower risk Drug recall · FDA · Published September 15, 2016

Pfizer recalls PREMARIN 1.25 mg tablets: Incorrect expiry date label

Pfizer recalls PREMARIN 1.25 mg tablets due to incorrect expiry date labeling. Affected bottles may have an expiry date of 11/17 instead of 09/17. Consumers should check labels and contact Pfizer for guidance.

🇺🇸 FDA recall #D-1528-2016DrugPfizer ›
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Recalling firmPfizer Inc.235 East 42nd Street · New York, NY 10017-5703
✎ GovInfoNow plain-language explainer

What happened, in plain English

Pfizer has recalled PREMARIN 1.25 mg tablets (1000-count bottles) because some bottles were incorrectly labeled with an expiry date of 11/17 instead of the correct 09/17. This labeling error could lead to confusion about when the medication expires, potentially causing unsafe use if the product is used after the correct expiry date. Read more at govinfonow.com/recall/42440-pfizer-recalls-premarin-1-25-mg-tablets-incorrect-expiry-date.

Source Summary by GovInfoNow · govinfonow.com/recall/42440-pfizer-recalls-premarin-1-25-mg-tablets-incorrect-expiry-date · Updated October 9, 2026 · FDA enforcement record: FDA #D-1528-2016

Cite this page

“Pfizer recalls PREMARIN 1.25 mg tablets: Incorrect expiry date label.” GovInfoNow, updated October 9, 2026. https://govinfonow.com/recall/42440-pfizer-recalls-premarin-1-25-mg-tablets-incorrect-expiry-date. Based on FDA recall #D-1528-2016 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1528-2016%22&limit=1).

Why it’s dangerous

The medication was labeled with an expiry date of November 17 instead of the correct September 17. If a user relies on the incorrect label, they might use the product after it has expired, which could lead to reduced effectiveness or potential safety issues.

Who’s affected

People who have a prescription for PREMARIN 1.25 mg tablets (1000-count bottles) from Pfizer or Wyeth Pharmaceuticals. Those most at risk are individuals who may use the medication after the incorrect expiry date label expires.

How to tell if you have this one

Check for PREMARIN 1.25 mg tablets (1000-count bottles) with a label showing an expiry date of 11/17 instead of 09/17. The product was distributed by Wyeth Pharmaceuticals and has NDC 0046-1104-91.

  • Brand
    Pfizer
  • Category
    Drug
Based on the official FDA remedy

What to do — step by step

  1. Check Label

    Look for the expiry date on the label; if it shows 11/17 instead of 09/17, the product is affected.

Where it went and when

Where it was distributed

Distributed nationwide.

Alaska: yesAKMaine: yesMEVermont: yesVTNew Hampshire: yesNHWashington: yesWAIdaho: yesIDMontana: yesMTNorth Dakota: yesNDMinnesota: yesMNIllinois: yesILWisconsin: yesWIMichigan: yesMINew York: yesNYRhode Island: yesRIMassachusetts: yesMAOregon: yesORNevada: yesNVWyoming: yesWYSouth Dakota: yesSDIowa: yesIAIndiana: yesINOhio: yesOHPennsylvania: yesPANew Jersey: yesNJConnecticut: yesCTCalifornia: yesCAUtah: yesUTColorado: yesCONebraska: yesNEMissouri: yesMOKentucky: yesKYWest Virginia: yesWVVirginia: yesVAMaryland: yesMDDelaware: yesDEArizona: yesAZNew Mexico: yesNMKansas: yesKSArkansas: yesARTennessee: yesTNNorth Carolina: yesNCSouth Carolina: yesSCDistrict of Columbia: yesDCOklahoma: yesOKLouisiana: yesLAMississippi: yesMSAlabama: yesALGeorgia: yesGAHawaii: yesHITexas: yesTXFlorida: yesFL

FDA distribution: “Nationwide” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide.

Recall timeline

FDA terminated this recall 11 months after the firm started it.

1. Firm started the recall: Sep 15, 201612. FDA classified it Class III: Sep 27, 201623. Published in FDA’s Enforcement Report: Oct 5, 201634. FDA terminated the recall: Aug 9, 2017420162017
  1. Firm started the recall
  2. FDA classified it Class III
  3. Published in FDA’s Enforcement Report
  4. FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

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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-1528-2016 (September 15, 2016) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-1528-2016 to see it in context.
  • Plain-language summary written by qwen3:4b 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.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA