Agency classClass IIIOur severity:Low FDA (Drugs)·D-1342-2020·Announced 2020-07-01

Pfizer Recalls Duavee Tablets Due to Failed Dissolution Specifications

Pfizer is recalling Duavee tablets because they failed to meet dissolution specifications. The recall covers 544,400 packages distributed nationwide.

The agency’s classification

FDA (Drugs): Class III

Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 1/5 (Low).

Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.

Our severity reasoning: The FDA classifies this recall as Class III, which by definition is unlikely to cause adverse health consequences, aligning with the 'Low' severity criteria for documentation or specification issues without reported harm.

Plain-English summary

Pfizer Inc. is recalling Duavee (conjugated estrogens/bazedoxifene) tablets 0.45/20 mg due to failed dissolution specifications. The affected product is packaged in 2 blister cards containing 15 tablets each (30 tablets total) and is distributed by Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer. The medication is made in Ireland and carries the NDC 00008-1123-12.

The recall involves 544,400 packages distributed nationwide within the United States. Specific lot numbers and expiration dates are listed in the recall documentation, including lots AF7814, AH6565, AP5189, CG8921, CL6603, DH5847, T17703, T99214, W46878, X07330, and X99074.

Consumers with this medication should contact their healthcare provider for guidance on alternative treatment options. The FDA classifies this recall as Class III, indicating that the product is not likely to cause adverse health consequences.

The recalled product

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
Manufacturer: Pfizer Inc.
Category: Drug — Prescription Medication
Hazard: dissolution-failure
Affected units: 544,400

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (18)

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

Distribution

Distributed nationwide across the United States.

Same manufacturer · Pfizer Inc.

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