FDA Drug recall D-1528-2016
PREMARIN (conjugated estrogen tablets, USP) 1.25 mg, 1000- count bottle, Rx only, Distributed by: Wyeth Pharmaceuticals Inc
- FDA Drug
- Class III
- terminated
- Published 2016-10-05
On 2016-10-05 the FDA classified a Class III recall of PREMARIN (conjugated estrogen tablets, USP) 1.25 mg, 1000- count bottle, Rx only, Distributed by: Wyeth Pharmaceuticals Inc by Pfizer, citing 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.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-1528-2016 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2016-09-15 |
| Published | 2016-10-05 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Pfizer |
| Distribution | US |
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
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.
Identifiers
| ndc | 0046-1101-81 |
|---|---|
| ndc | 0046-1102-81 |
| ndc | 0046-1102-91 |
| ndc | 0046-1102-52 |
| ndc | 0046-1104-81 |
| ndc | 0046-1104-91 |
| ndc | 0046-1100-81 |
| ndc | 0046-1100-91 |
| ndc | 0046-1100-52 |
| ndc | 0046-1103-81 |
| code_info | Lot # M35953S; Exp. 11/17 (labeled). |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1528-2016%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.