Duavee — Class III drug recall D-1342-2020
Terminated recall by Pfizer Inc., reported 2020-07-01, distributed nationwide. Failed Dissolution Specifications
| Recall number | D-1342-2020 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Pfizer Inc., New York, NY, United States |
| Recall initiated | 2020-05-27 |
| Classified | 2020-06-24 |
| Reported by FDA | 2020-07-01 |
| Terminated | 2023-06-30 |
| Distributed | Nationwide (US) |
| Quantity | 544,400 packages |
| Reason classes | specification failure |
| NDC | 00008-1123-12 |
| Lot numbers | 2020, 2020JUN, 2020SEP, 2021AUG, 2021JUN, 2021SEP, 2022FEB, 2022MAR, AF7814, AH6565, AP5189, CG8921, CL6603, DH5847, SEP30, T17703, T99214, W46878, X07330, X99074 |
Product
Duavee (conjugated estrogens/bazedoxifene) tablets 0.45/20 mg, packaged in 2 blister cards containing 15 tablets each (30 tablets), Rx Only, Distributed by Wyeth Pharmaceuticals LLC A subsidiary of Pfizer In Philadelphia, PA 19101 Made in Ireland, NDC 00008-1123-12
Reason for recall
Failed Dissolution Specifications
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-1342-2020. 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.