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Drug recall · FDA · Published May 27, 2020

Pfizer Inc. recalls Duavee (conjugated estrogens/bazedoxifene) tablets 0.45/20 mg, packaged in 2 blister cards containing 15 tablets each

Pfizer recalls Duavee (conjugated estrogens/bazedoxifene) tablets 0.45/20 mg with failed dissolution specifications. Rx-only medication distributed by Wyeth in Ireland. No remedy specified in recall notice.

🇺🇸 FDA recall #D-1342-2020DrugPfizer ›
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Contact the company & request your remedy

Recalling firmPfizer Inc.235 E 42nd St, N/A · New York, NY 10017-5703
No email on file for this recall — reach the company by phone or its official page instead.No email on file — write to the address above instead.
✎ GovInfoNow plain-language explainer

What happened, in plain English

Pfizer has recalled a specific type of Duavee hormone tablets due to failed dissolution specifications. This means the tablets may not release medication properly, potentially affecting treatment effectiveness. The recall applies to prescription-only tablets sold in Ireland with certain lot numbers. Read more at govinfonow.com/recall/37097-pfizer-duavee-tablets-0-45-20-mg-recall-failed-dissolution.

Source Summary by GovInfoNow · govinfonow.com/recall/37097-pfizer-duavee-tablets-0-45-20-mg-recall-failed-dissolution · Updated October 5, 2026 · FDA enforcement record: FDA #D-1342-2020

Cite this page

“Pfizer Duavee Tablets 0.45/20 mg Recall: Failed Dissolution Specifications.” GovInfoNow, updated October 5, 2026. https://govinfonow.com/recall/37097-pfizer-duavee-tablets-0-45-20-mg-recall-failed-dissolution. Based on FDA recall #D-1342-2020 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1342-2020%22&limit=1).

Why it’s dangerous

The tablets failed to dissolve correctly as tested, which could lead to improper medication release. This might affect how well the hormone treatment works over time. However, the recall does not specify if this causes serious harm in normal use.

Who’s affected

Prescription holders of Duavee tablets 0.45/20 mg in 2 blister cards containing 15 tablets each. Women with hormone-related conditions who require this medication are most at risk.

How to tell if you have this one

Check for Duavee tablets 0.45/20 mg in 2 blister cards with 15 tablets each. Look for lot numbers AF7814 (2021 AUG 31), AH6565 (2021 SEP 30), AP5189 (2020 SEP 30), CG8921 (2022 FEB 28), CL6603 (2022 MAR 31), T17703 (2020 JUN 30), W46878 (2020 SEP 30), X99074 (2021 JUN 30).

  • Brand
    Pfizer
  • Category
    Drug
Based on the official FDA remedy

What to do — step by step

  1. Check Product Details

    Identify if your Duavee tablets match the recalled packaging and lot numbers listed in the notice.

✎ GovInfoNow

Questions people ask

Is this product safe to use?

The recall states the tablets failed dissolution specifications, but does not specify if this causes serious harm in normal use. The official notice does not provide details on safety risks.

What should I do if I have these tablets?

The recall notice does not specify a remedy, so no action is required beyond checking if your product matches the recalled details.

Are there any specific lot numbers I should avoid?

Yes, avoid lot numbers AF7814 (2021 AUG 31), AH6565 (2021 SEP 30), AP5189 (2020 SEP 30), CG8921 (2022 FEB 28), CL6603 (2022 MAR 31), T17703 (2020 JUN 30), W46878 (2020 SEP 30), X99074 (2021 JUN 30).

Take action

Contact Pfizer

We’ve drafted a message you can send Pfizer to request your refund or repair — edit it as you like.

Subject: Recall D-1342-2020 — Pfizer Pfizer

Hello,

I own a Pfizer that is covered by recall D-1342-2020 from Pfizer.

I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this?

Thank you.

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Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

  • Official source: FDA Recall #D-1342-2020 (May 27, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-1342-2020 to see it in context.
  • Plain-language summary written by qwen3:4b on October 5, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
  • GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA