PREMARIN — Class III drug recall D-1528-2016
Terminated recall by Pfizer Inc., reported 2016-10-05, distributed nationwide. Labeling: Incorrect or Missing Lot and/or Exp Date: Bottles were incorrectly labeled with an expiry date of 11
| Recall number | D-1528-2016 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Pfizer Inc., New York, NY, United States |
| Recall initiated | 2016-09-15 |
| Classified | 2016-09-27 |
| Reported by FDA | 2016-10-05 |
| Terminated | 2017-08-09 |
| Distributed | Nationwide (US) |
| Reason classes | labeling |
| NDC | 00046-1100, 00046-1100-52, 00046-1100-81, 00046-1100-91, 00046-1101, 00046-1101-81, 00046-1102, 00046-1102-52, 00046-1102-81, 00046-1102-91, 00046-1103, 00046-1103-81, 00046-1104, 00046-1104-81, 00046-1104-91 |
| Lot numbers | 11/17, M35953S |
Product
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
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-1528-2016. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.