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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Low RiskFDA Drug
Medications & Supplements/Prescription Drugs

Pfizer Inc.: Duavee (conjugated estrogens/bazedoxifene) Recalled for Failed Dissolution

Agency Publication Date: June 24, 2020
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Summary

Pfizer Inc. has recalled approximately 544,400 packages of Duavee (conjugated estrogens/bazedoxifene) 0.45/20 mg tablets because the medication failed dissolution specifications. This defect means the tablets may not break down or dissolve as intended after being swallowed. The recall affects 30-count packages (two 15-tablet blister cards) that were distributed nationwide. Consumers are advised to consult with their healthcare provider regarding their treatment and return affected products for a refund.

Risk

If the medication fails to dissolve properly, the body may not absorb the correct amount of active ingredients. This can lead to a lower-than-intended dose, which may reduce the effectiveness of the drug in managing symptoms or preventing the conditions for which it was prescribed.

What You Should Do

  1. Check your medication packaging for Duavee (conjugated estrogens/bazedoxifene) 0.45/20 mg tablets with NDC 00008-1123-12.
  2. Identify if your package belongs to any of the following lot numbers: AF7814 (Exp: 8/31/2021), AH6565 (Exp: 9/30/2021), AP5189 (Exp: 9/30/2020), CG8921 (Exp: 2/28/2022), CL6603, DH5847 (Exp: 3/31/2022), T17703 (Exp: 6/30/2020), T99214 (Exp: 6/30/2020), W46878 (Exp: 9/30/2020), X07330 (Exp: 9/30/2020), or X99074 (Exp: 6/30/2021).
  3. Contact your healthcare provider or pharmacist immediately to discuss your treatment and determine if a replacement prescription is necessary.
  4. Return any unused product from the affected lots to your pharmacy to receive a refund.
  5. Contact Pfizer Inc. at 1-800-438-1985 for additional information or further instructions regarding this recall.
  6. For further questions, contact the FDA Consumer Complaint hotline at 1-888-723-3332.

Your Remedy Options

๐Ÿ’ฐFull Refund

Contact your healthcare provider or pharmacist for guidance. Return any unused product to the pharmacy for a refund

How to: Consumers should contact their pharmacy for refund information and their healthcare provider for medical guidance.

Affected Products

Product: Duavee (conjugated estrogens/bazedoxifene) tablets 0.45/20 mg (30 tablets)
Model:
NDC 00008-1123-12
Lot Numbers:
AF7814 (Exp 2021 AUG 31)
AH6565 (Exp 2021 SEP 30)
AP5189 (Exp 2020 SEP 30)
CG8921 (Exp 2022 FEB 28)
CL6603
DH5847 (Exp 2022 MAR 31)
T17703 (Exp 2020 JUN 30)
T99214 (Exp 2020 JUN 30)
W46878 (Exp 2020 SEP 30)
X07330 (Exp 2020 SEP 30)
X99074 (Exp 2021 JUN 30)
Date Ranges: 2020 JUN 30, 2020 SEP 30, 2021 JUN 30, 2021 AUG 31, 2021 SEP 30, 2022 FEB 28, 2022 MAR 31

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 85725
Status: Resolved
Manufacturer: Pfizer Inc.
Sold By: Pharmacies
Manufactured In: United States, Ireland
Units Affected: 544400 packages
Distributed To: Nationwide

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.