CLASS III Drug recall · Reported 5 Oct 2016 · FDA Enforcement Report
Premarin (conjugated estrogen tablets, USP) 25 mg recalled by Pfizer
Pfizer is recalling Premarin (conjugated estrogen tablets, USP) 25 mg, distributed nationwide in the US. The recall was initiated on 15 Sep 2016 and the FDA has classified it as Class III.
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-1528-2016
- FDA event ID
- 75225
- Recalling firm
- Pfizer, New York, NY
- Brand
- Premarin
- Manufacturer
- Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 15 Sep 2016
- FDA classified
- 27 Sep 2016
- Reported
- 5 Oct 2016
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Labeling Errors
Timeline
| 15 Sep 2016 | Recall initiated by company | |
| 27 Sep 2016 | Classified by FDA | +12 days |
| 5 Oct 2016 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Labeling: Incorrect or Missing Lot and/or Exp Date: Bottles were incorrectly labeled with an expiry date of 11/17; the correct date is 09/17.
Product as listed by the FDA
PREMARIN (conjugated estrogen tablets, USP) 1.25 mg, 1000- count bottle, Rx only, Distributed by: Wyeth Pharmaceuticals Inc. A subsidiary of Pfizer Inc. Philadelphia, PA 19101, NDC 0046-1104-91
Where it was distributed
Nationwide
Questions about this recall
Is Premarin (conjugated estrogen tablets, USP) 25 mg recalled?
Yes. Pfizer recalled Premarin (conjugated estrogen tablets, USP) 25 mg on 15 Sep 2016. The recall is Class III and its status is Terminated. Recall number D-1528-2016.
Why was it recalled?
Labeling: Incorrect or Missing Lot and/or Exp Date: Bottles were incorrectly labeled with an expiry date of 11/17; the correct date is 09/17.
Which lots are affected?
Lot # M35953S; Exp. 11/17 (labeled).
Where was it sold?
Nationwide
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 III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
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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