Duavee Tablets (Pfizer) – Dissolution Failure (2020)
Class III: A situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences
Class III recall indicates unlikely adverse health consequences.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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
Brand
Pfizer Inc.
Lot Codes / Batch Numbers
Lot #: AF7814, 2021 AUG 31, AH6565, 2021 SEP 30, AP5189, 2020 SEP30, CG8921, 2022 FEB 28, CL6603, DH5847, 2022 MAR 31, T17703, T99214 2020 JUN 30, W46878, X07330, 2020 SEP 30, X99074, 2021 JUN 30
Products Sold
Lot #: AF7814, 2021 AUG 31; AH6565, 2021 SEP 30, AP5189, 2020 SEP30; CG8921, 2022 FEB 28; CL6603, DH5847, 2022 MAR 31; T17703, T99214 2020 JUN 30, W46878, X07330, 2020 SEP 30; X99074, 2021 JUN 30
Pfizer Inc. is recalling Duavee (conjugated estrogens/bazedoxifene) tablets 0.45/20 mg, packaged in 2 blister cards containin due to Failed Dissolution Specifications. This is a Class I recall, indicating a high risk of serious health consequences. Based on FDA drug enforcement report.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Failed Dissolution Specifications
Recommended Action
Per FDA guidance
Consumers should stop using the product and contact the recalling firm, their healthcare provider, or return it to the place of purchase.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 7, 2026