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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 75225

1 recalled-product record grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
September 15, 2016
Product types
Drug
Classifications
Class III
Statuses
Terminated
Recalling firm wording
Pfizer Inc.

Dossier provenance

Source snapshots represented here

  • openFDA Drug Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

drug · product 1 of 1

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

D-1528-2016
Recall number
D-1528-2016
Initiated
September 15, 2016
Classification
Class III
Status
Terminated
Recalling firm
Pfizer Inc.
Quantity
1,316 bottles (1,316,000 tablets)

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
Labeling: Incorrect or Missing

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

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.

Code information

Lot # M35953S; Exp. 11/17 (labeled).

Distribution pattern

Nationwide

Field note

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