Menopause Medication Recalled

Pfizer Inc. is recalling a half-million packages of Duavee (conjugated estrogens/bazedoxifene) tablets, 0.45/20 mg, for failing to meet dissolution specifications during routine testing. The voluntary recall was included in the July 1, 2020, US Food and Drug Administration (FDA) Enforcement Report. 

The recall affects Duavee tablets, packaged in two blister cards containing 15 tablets each (NDC 00008-1123-12), from lots AF7814 (Exp. 8/31/21), AH6565 (Exp. 9/30/21), AP5189 (Exp. 9/30/20), CG8921 (Exp. 2/28/22), CL6603 and DH5847 (Exp. 3/31/22), T17703 and T99214 (Exp. 6/30/20), W46878 and X07330 (Exp. 9/30/20), and X99074 (Exp. 6/30/21). The tablets were distributed by Wyeth Pharmaceuticals, a subsidiary of Pfizer, throughout the United States.

Pfizer initiated the recall May 27, 2020. The FDA designated the recall Class III on June 24, 2020, communicating use of the affected tablets is not likely to cause harm.

Available with a prescription, Duavee is a fixed-dose combination medication used to treat menopause symptoms and postmenopausal osteoporosis.

—Jolynn Tumolo