Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.
NDC labeler codes: 0008, 0046, 0206
What is a labeler?
The company whose name is on the package and in the FDA’s National Drug Code (NDC) Directory. It may make the medicine itself or sell medicine made by another company. The first part of every NDC code identifies the labeler.
Official FDA data only
Products, approvals and recalls come from the FDA (NDC Directory, Drugs@FDA, enforcement reports). Recalls are linked to this company by the NDC labeler code on the recalled product.
Questions about your medicine: ask your doctor or pharmacist. In an emergency, call 911.
Prescription medicines
- Estrogens, conjugatedPremarin, Premarin Vaginal · 7 products
- Pantoprazole sodiumProtonix I.V., Protonix Delayed-Release, Pantoprazole Sodium I.V. · 5 products
- Conjugated estrogens and medroxyprogesterone acetatePrempro · 4 products
- DesvenlafaxinePristiq Extended-Release · 3 products
- Piperacillin and tazobactamZosyn in Galaxy Containers, Zosyn · 3 products
- TigecyclineTygacil · 2 products
- Coral snake (micrurus fulvius) immune globulin antivenin (equine)North American Coral Snake Antivenin (Equine) · 1 product
- Gemtuzumab ozogamicinMylotarg · 1 product
- Inotuzumab ozogamicinBesponsa · 1 product
- Conjugated estrogens/bazedoxifeneDuavee · 1 product
FDA applications for these products
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
- BLA: Biologics License Application: how a biologic medicine (made from living cells) is approved.
| Approved | Application | Medicine | Sponsor |
|---|---|---|---|
| September 1, 2017 | BLA761060 | Gemtuzumab ozogamicin MYLOTARG | Wyeth Pharms Inc |
| August 17, 2017 | BLA761040 | Inotuzumab ozogamicin BESPONSA | Wyeth Pharms Inc |
| October 3, 2013 | NDA022247 | Conjugated estrogens/bazedoxifene DUAVEE | Wyeth Pharms |
| February 29, 2008 | NDA021992 | Desvenlafaxine PRISTIQ | Pf Prism Cv |
| November 14, 2007 | NDA022020 | Pantoprazole sodium PROTONIX | Wyeth Pharms |
| June 15, 2005 | NDA021821 | Tigecycline TYGACIL | Pf Prism Cv |
| March 22, 2001 | NDA020988 | Pantoprazole sodium PROTONIX IV | Wyeth Pharms |
| February 2, 2000 | NDA020987 | Pantoprazole sodium PROTONIX | Wyeth Pharms |
| February 24, 1998 | NDA050750 | Piperacillin and tazobactam ZOSYN IN PLASTIC CONTAINER | Baxter Hlthcare Corp |
| November 17, 1995 | NDA020527 | Conjugated estrogens and medroxyprogesterone acetate PREMPHASE 14/14, PREMPRO | Wyeth Pharms |
| October 16, 1978 | NDA020216 | Estrogens, conjugated PREMARIN | Wyeth Pharms |
| December 18, 1956 | NDA010402 | Estrogens, conjugated PREMARIN | Wyeth Pharms |
| May 8, 1942 | NDA004782 | Estrogens, conjugated PREMARIN | Wyeth Pharms |
| — | BLA101099 | Coral snake (micrurus fulvius) immune globulin antivenin (equine) | — |
The sponsor is the company that holds the FDA application; it can differ from the labeler.
Recall timeline
2016
-
November 22, 2016 · Class III · Terminated · D-0516-2017 · Pantoprazole sodium
Subpotent Drug: Out of Specification (OOS) for potency at the 6-month stability time point.
PROTONIX I.V. (pantoprazole sodium) for Injection, Equivalent to 40 mg pantoprazole per vial, For I.V. infusion only, Rx Only, Distributed by Wyeth Pharmaceuticals Inc, A subsidiary of Pfizer Inc, Philadelphia, PA 19101,
-
September 15, 2016 · Class III · Terminated · D-1528-2016 · Estrogens, conjugated
Labeling: Incorrect or Missing Lot and/or Exp Date: Bottles were incorrectly labeled with an expiry date of 11/17; the correct date is 09/17.
PREMARIN (conjugated estrogen tablets, USP) 1.25 mg, 1000- count bottle, Rx only, Distributed by: Wyeth Pharmaceuticals Inc. A subsidiary of Pfizer Inc. Philadelphia, PA 19101, NDC 0046-1104-91
2014
-
April 16, 2014 · Class II · Terminated · D-1409-2014 · Desvenlafaxine
Presence of Foreign Tablets/Capsules: Pfizer is recalling 50 mg Pristiq (desvenlafaxine) extended release tablets because a single Pristiq 100 mg tablet was found in a bottle of 50 mg Pristiq.
Pristiq (desvenlafaxine) Extended-Release Tablets 50 mg, 30 count bottle, Rx only, Distributed by Wyeth Pharmaceuticals, Inc., NDC 0008-1211-30
What do the recall classes mean?
Class I: The most serious type: there is a reasonable chance that using the product will cause serious health problems or death.
Class II: Using the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
Class III: Using the product is not likely to cause health problems (for example a labeling or packaging issue).
Sources
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026