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Drug company (FDA labeler)

Pfizer Laboratories Div Pfizer Inc

NDC labeler codes: 0013, 0025, 0069, 55724, 60793, 61570, 72618

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.

At a glance

57Prescription medicines
178Products (NDC)
68FDA applications
49Recalls

Prescription medicines

FDA applications for these products

  • NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
  • ANDA: Abbreviated New Drug Application: how a generic version is approved.
  • BLA: Biologics License Application: how a biologic medicine (made from living cells) is approved.
ApprovedApplicationMedicineSponsor
October 11, 2024BLA761369 Marstacimab-hncq
HYMPAVZI		Pfizer Inc
March 7, 2024NDA217439 Talazoparib
TALZENNA		Pfizer
October 12, 2023NDA216956 Etrasimod
VELSIPITY		Pfizer
September 26, 2023NDA217729 Bosutinib
BOSULIF		Pf Prism Cv
September 7, 2023NDA217581 Crizotinib
XALKORI		Pf Prism Cv
August 14, 2023BLA761345 Elranatamab-bcmm
ELREXFIO		Pfizer Inc
June 27, 2023BLA761184 Somatrogon-ghla
NGENLA		Pfizer Ireland Pharmaceuticals
June 23, 2023NDA215830 Ritlecitinib
LITFULO		Pfizer
March 9, 2023NDA216386 Zavegepant
ZAVZPRET		Pfizer
January 14, 2022NDA213871 Abrocitinib
CIBINQO		Pfizer
September 25, 2020NDA213082 Tofacitinib
XELJANZ		Pfizer
September 16, 2020ANDA205576 Propofol
PROPOFOL		Innopharma
June 10, 2020BLA761111 Pegfilgrastim-cbqv
NYVEPRIA		Hospira Inc
February 27, 2020NDA212728 Rimegepant sulfate
NURTEC ODT		Pfizer
November 1, 2019NDA212436 Palbociclib
IBRANCE		Pfizer
July 23, 2019BLA761103 Rituximab-arrx
RUXIENCE		Pfizer Inc
June 27, 2019BLA761099 Bevacizumab-bvzr
ZIRABEV		Pfizer Inc
May 3, 2019NDA211996 Tafamidis
VYNDAQEL		Foldrx Pharms
May 3, 2019NDA212161 Tafamidis
VYNDAMAX		Foldrx Pharms
March 11, 2019BLA761081 Trastuzumab
TRAZIMERA		Pfizer Inc
November 21, 2018NDA210656 Glasdegib
DAURISMO		Pfizer
November 2, 2018NDA210868 Lorlatinib
LORBRENA		Pfizer
October 16, 2018NDA211651 Talazoparib
TALZENNA		Pfizer
September 27, 2018NDA211288 Dacomitinib
VIZIMPRO		Pfizer
July 20, 2018BLA761080 Filgrastim
NIVESTYM		Hospira Inc
May 15, 2018BLA125545 Epoetin alfa-epbx
RETACRIT		Hospira Inc
December 14, 2016NDA207695 Crisaborole
EUCRISA		Anacor Pharms Inc
April 5, 2016BLA125544 Infliximab
INFLECTRA		Celltrion Inc
February 23, 2016NDA208246 Tofacitinib
XELJANZ XR		Pfizer
February 3, 2015NDA207103 Palbociclib
IBRANCE		Pfizer
November 6, 2012NDA203214 Tofacitinib
XELJANZ		Pf Prism Cv
September 4, 2012NDA203341 Bosutinib
BOSULIF		Pf Prism Cv
May 1, 2012BLA022458 Taliglucerase alfa
ELELYSO		Pfizer
January 27, 2012NDA202324 Axitinib
INLYTA		Pf Prism Cv
August 26, 2011NDA202570 Crizotinib
XALKORI		Pf Prism Cv
July 21, 2011NDA201370 Heparin sodium
HEPARIN SODIUM, HEPARIN SODIUM PRESERVATIVE FREE		Pfizer
October 31, 2008NDA022030 Fesoterodine fumarate
TOVIAZ		Pfizer
May 10, 2006NDA021928 Varenicline tartrate
CHANTIX		Pf Prism Cv
January 26, 2006NDA021938 Sunitinib malate
SUTENT		Cppi Cv
June 3, 2005NDA021845 Sildenafil
REVATIO		Viatris
January 30, 2004NDA021540 Amlodipine and atorvastatin
CADUET		Pharmacia
May 24, 2002NDA050784 Azithromycin
ZITHROMAX		Pfizer
May 25, 2001NDA021301 Levothyroxine
LEVOXYL		King Pharms
October 1, 1999NDA020931 Dofetilide
TIKOSYN		Pfizer
March 27, 1998NDA020895 Sildenafil
VIAGRA		Viatris
December 24, 1997NDA020607 Diclofenac sodium and misoprostol
ARTHROTEC		Pfizer
February 17, 1997NDA050734 Idarubicin hydrochloride
IDAMYCIN PFS, IDARUBICIN HYDROCHLORIDE		Pfizer
January 30, 1997NDA050733 Azithromycin
ZITHROMAX		Pfizer
August 5, 1996NDA020450 Fosphenytoin sodium
CEREBYX		Parke Davis
July 18, 1996NDA050711 Azithromycin
ZITHROMAX		Pfizer
April 26, 1996NDA020472 Estradiol
ESTRING		Pfizer
October 19, 1995NDA050710 Azithromycin
ZITHROMAX		Pfizer
May 3, 1995NDA020334 Metronidazole
FLAGYL		Pfizer
December 22, 1994NDA020287 Dalteparin sodium
FRAGMIN		Pfizer
July 31, 1992NDA019787 Amlodipine
NORVASC		Viatris
February 13, 1990NDA019886 Nafarelin acetate
SYNAREL		Pfizer
September 6, 1989NDA019684 Nifedipine
PROCARDIA XL		Pfizer
December 27, 1988NDA019268 Misoprostol
CYTOTEC		Pfizer
December 23, 1987NDA050629 Doxorubicin hydrochloride
DOXORUBICIN HYDROCHLORIDE		Pfizer
December 30, 1986NDA019281 Tranexamic acid
CYKLOKAPRON		Pfizer
September 1, 1977NDA017447 Disopyramide phosphate
NORPACE		Pfizer
November 26, 1973NDA017381 Silver sulfadiazine
SILVADENE		King Pharms LLC
September 15, 1960NDA012462 Diphenoxylate hydrochloride and atropine sulfate
LOMOTIL		Pfizer
January 21, 1960NDA012151 Spironolactone
ALDACTONE		Pfizer
May 8, 1956NDA010379 Liothyronine sodium
CYTOMEL		King Pharms
May 18, 1953NDA050138 Penicillin g benzathine and penicillin g procaine
BICILLIN C-R, BICILLIN C-R 900/300		King Pharms LLC
June 27, 1952NDA050141 Penicillin g benzathine
BICILLIN L-A		King Pharms LLC
June 20, 1950NDA007073 Sulfasalazine
AZULFIDINE, AZULFIDINE EN-TABS		Pfizer

The sponsor is the company that holds the FDA application; it can differ from the labeler.

Recall timeline

2025

  1. July 29, 2025 · Class II · Ongoing · D-0575-2025 · Levothyroxine

    Subpotent drug

    Levoxyl (levothyroxine sodium tablets, USP), 50 mcg, 100-count bottle, Rx only, Distributed by: Pfizer Inc., New York, NY 10017, Made in Austria, NDC 60793-851-01.

  2. July 10, 2025 · Class II · Ongoing · D-0545-2025 · Penicillin g benzathine

    CGMP Deviations; particulates identified during visual inspection

    Bicillin L-A (penicillin G benzathine injectable suspension), 2,400,000 units per 4 mL, 4ml-vial, Rx Only, Distributed by Pfizer Inc., New York, NY 10001, Made in Austria, Carton NDC- 60793-702-10 , Syringe NDC-60793-702

  3. July 10, 2025 · Class II · Ongoing · D-0544-2025 · Penicillin g benzathine

    CGMP Deviations; particulates identified during visual inspection

    Bicillin L-A (penicllin G benzathine injectable suspension), 1,200,000 units per 2 mL, 2 mL-vial, Rx Only, Distributed by Pfizer Inc., New York, NY 10001. Made in Austria, Carton NDC - 60793-701-10, Syringe NDC - 60793-7

  4. January 17, 2025 · Class II · Ongoing · D-0213-2025 · Infliximab

    cGMP Deviations: Product intended for quarantine was inadvertently distributed.

    Inflectra (infliximab-dyyb), For injection, 100mg per vial, packaged in 10 mL single-dose vial, Rx only, Mfd by: CELLTRION, INC, Dist. by: Pfizer Labs, Division of Pfizer Inc., New York, NY 10001, NDC 0069-0809-01

2021

  1. August 13, 2021 · Class II · Ongoing · D-0810-2021 · Varenicline tartrate

    CGMP Deviations: Presence of the N-nitroso-varenicline impurity above FDA s acceptable interim acceptable intake limit

    Chantix (varenicline) tablets 1 mg, 56 Tablets, Rx only, Distributed by Pfizer Labs, Division of Pfizer Inc. NY, NY 10017, Made in Ireland, NDC 0069-0469-56.

  2. August 13, 2021 · Class II · Ongoing · D-0811-2021 · Varenicline tartrate

    CGMP Deviations: Presence of the N-nitroso-varenicline impurity above FDA s acceptable interim acceptable intake limit

    Chantix (varenicline) tablets 1 mg, Carton containing 4 blister packs of 14 tablets each,, Rx only, Distributed by Pfizer Labs, Division of Pfizer Inc. NY, NY 10017, Made in Ireland, NDC 0069-0469-03. EXPIRATION DATE: Se

  3. August 13, 2021 · Class II · Ongoing · D-0809-2021 · Varenicline tartrate

    CGMP Deviations: Presence of the N-nitroso-varenicline impurity above FDA s acceptable interim acceptable intake limit

    Chantix (varenicline) tablets 0.5mg, 56 Tablets, Rx only, Distributed by Pfizer Labs, Division of Pfizer Inc. NY, NY 10017, Made in Ireland, NDC 0069-0468-56.

  4. June 9, 2021 · Class II · Ongoing · D-0699-2021 · Varenicline tartrate

    CGMP Deviations: Presence of the N-nitroso-varenicline impurity above FDA s acceptable interim acceptable intake limit

    Chantix (varenicline) tablets, 0.5mg*, 56 Tablets, Rx Only, Distributed by Pfizer Labs, Division of Pfizer Inc., NY, NY 10017, Made in Ireland. NDC 0069-0468-56

  5. June 9, 2021 · Class II · Ongoing · D-0701-2021 · Varenicline tartrate

    CGMP Deviations: Presence of the N-nitroso-varenicline impurity above FDAs acceptable interim acceptable intake limit

    Chantix (varenicline) tablets, 1 mg, 56 Tablets, Rx Only, Distributed by Pfizer Labs, Division of Pfizer Inc., NY, NY 10017, Made in Ireland. NDC 0069-0469-56

  6. June 9, 2021 · Class II · Ongoing · D-0700-2021 · Varenicline tartrate

    CGMP Deviations: Presence of the N-nitroso-varenicline impurity above FDAs acceptable interim acceptable intake limit

    Chantix (varenicline)Tablets, Contains: 1 Starting Week (0.5 mg* x 11 tablets), 3 Continuing Weeks (1 mg x 42 tablets), Rx Only, Distributed by Pfizer Labs, Division of Pfizer Inc, NY, NY 10017, Made in Ireland, NDC 0069

  7. March 15, 2021 · Class II · Terminated · D-0555-2021 · Varenicline tartrate

    CGMP Deviations: Intermittent exposure to temperature excursion during storage.

    Chantix (varenicline) Tablets Continuing Month Box Contains: 4 Continuing Weeks (1 mg x 56 tablets) Rx only ; Rx only Distributed by Pfizer Labs Division of Pfizer, Inc., NY, NY ,10017NDC 0069-0469-56

  8. March 15, 2021 · Class II · Terminated · D-0557-2021 · Levothyroxine

    CGMP Deviations: Intermittent exposure to temperature excursion during storage.

    LEVOXYL Tablets, USD, 150MCG, 100-count bottle, Rx Only, Distributed by Pfizer Inc., New York, NY 10017, MADE IN AUSTRIA, NDC: 60793-858-01

  9. March 15, 2021 · Class II · Terminated · D-0556-2021 · Varenicline tartrate

    CGMP Deviations: Intermittent exposure to temperature excursion during storage.

    Chantix (varenicline) Tablets Starting Pack Contains: 1 Starting Week (0.5 mgx11 tablets) 3 Continuing Weeks (1 mgx42 tablets) Rx only NDC 0069-0471-03 Distributed by Pfizer Labs Division of Pfizer, Inc., NY, NY 10017

  10. March 15, 2021 · Class II · Terminated · D-0554-2021 · Varenicline tartrate

    CGMP Deviations: Intermittent exposure to temperature excursion during storage.

    Chantix (varenicline) Tablets Continuing Month Box Contains: 4 Continuing Weeks (1 mg x 56 tablets) Rx only NDC 0069-0469-03 Distributed by Pfizer Labs Division of Pfizer Inc., NY, NY 10017

  11. March 15, 2021 · Class II · Terminated · D-0451-2021 · Rimegepant sulfate

    CGMP Deviations: Intermittent exposure to temperature excursion during storage.

    NURTEC ODT (RIMEGEPANT) 75MG 8 BPK; NDC/UPC 72618-3000-2; RX; TABLETS FOR RAPID DISSOLUTION (NOT SUBLINGUAL)

2020

  1. February 27, 2020 · Class II · Terminated · D-0995-2020 · Taliglucerase alfa

    Lack of Assurance of Sterility--Reports of loose metal ferrule crimps on vials for injection. The entire cap either lifted or dislodged while attempting to flip off the orange color plastic button.

    Elelyso (taliglucerase alfa) for injection, 200 units/vials,, Rx only, Distributed by Pfizer Labs, Division of Pfizer Inc, NY, NY 10017. NDC 0069-0106-01

  2. February 5, 2020 · Class II · Terminated · D-0841-2020 · Amlodipine and atorvastatin

    Defective Container: products potentially could have been packaged in defective bottles, with a notched rim, that could cause inadequate foil sealing resulting in lack of moisture protection.

    Caduet (amlodipine besylate/atorvastatin calcium) Tablets, 10 mg/20 mg*, 30-count bottle, Rx only, Distributed by: Pfizer Labs, Division of Pfizer Inc. NY, NY 10017, Made in Germany, NDC 0069-2180-30.

  3. February 5, 2020 · Class II · Terminated · D-0842-2020 · Amlodipine and atorvastatin

    Defective Container: products potentially could have been packaged in defective bottles, with a notched rim, that could cause inadequate foil sealing resulting in lack of moisture protection.

    Caduet (amlodipine besylate/atorvastatin calcium) Tablets, 10 mg/10 mg*, 30-count bottle, Rx only, Distributed by: Pfizer Labs, Division of Pfizer Inc. NY, NY 10017, Made in Germany, NDC 0069-2160-30.

2018

  1. December 6, 2018 · Class II · Terminated · D-0339-2019 · Levothyroxine

    Superpotent Drug.

    Levoxyl (levothyroxine sodium tablets, USP) tablets 112 mcg, 100-count bottle, Rx Only,Distributed by Pfizer Inc. New York, NY 10017, NDC 60793-855-01

  2. September 19, 2018 · Class II · Terminated · D-0005-2019 · Taliglucerase alfa

    Lack of assurance of sterility -Reports of loose metal ferrule crimps on vials for injection. The entire cap either lifted or dislodged while attempting to flip off the orange color plastic button.

    Elelyso (taliglucerase alfa) for injection, 200 units/vial, single-use vial, Rx only, Distributed by Pfizer Labs, Division of Pfizer Inc, NY, NY 10017, NDC 0069-0106-01

2016

  1. November 7, 2016 · Class II · Terminated · D-0150-2017 · Levothyroxine

    Superpotent

    LEVOXYL(R) (levothyroxine sodium tablets, USP), 200 mcg, 100 count bottles, Rx only, Manufactured and Distributed by: King Pharmaceuticals, Inc., Bristol, TN 37620, NDC 60793-860-01

  2. September 9, 2016 · Class III · Terminated · D-0424-2017 · Misoprostol

    Failed Impurities/Degradations Specifications; Out of specification results for two known degradation products and total impurities at 18 months

    Cytotec (misoprostol) Tablets, 200 mcg, 100 Tablets blister pack (10X10), For in-institution use only, Rx only, Distributed by G.D. Searle, Division of Pfizer, Inc., NY, NY --- NDC 0025-1461-34

2015

  1. December 2, 2015 · Class III · Terminated · D-0520-2016 · Disopyramide phosphate

    Failed Dissolution Specification

    Norpace CR (disopyramide phosphate) extended-release capsules USP,150 mg, packaged in a) 100-count bottles (NDC 0025-2742-31), and b) 500-count bottles (NDC 0025-2742-51), Rx only, Distributed by G.D. Searle LLC, Divisio

2014

  1. December 3, 2014 · Class II · Terminated · D-0292-2015 · Dofetilide

    Failed Tablet/Capsule Specifications: Product being recalled due to the potential presence of cracked or broken capsules.

    Tikosyn (dofetilide) 125 mcg (0.125 mg), a) 14-count bottle (NDC 0069-5800-61), b) 60-count bottle (NDC 0069-5800-60), Rx Only, Manufactured by Pfizer Labs, Division of Pfizer, Inc., NY, NY 10017.

  2. January 2, 2014 · Class III · Terminated · D-745-2014 · Azithromycin

    Failed Impurities/Degradation Specifications: Pfizer is recalling certain lots due to out of specification results for azithromycin N-oxide degradant.

    Zithromax (azithromycin for injection), 500 mg/vial, Sterile, Rx Only, For I.V. infusion only, No latex, No preservative, Made in Ireland, Distributed by Pfizer Labs, Division of Pfizer Inc, NY, NY 10017, NDC 0069-3150-8

2013

  1. September 4, 2013 · Class II · Terminated · D-014-2014 · Spironolactone

    Marketed without an Approved NDA/ANDA: This recall is being initiated because of changes to the dissolution profile in distributed lots resulting from a manufacturing site change. There is currently no approved application supporting the alternate manufacturing site.

    Aldactone (spironolactone) tablets, USP, 100 mg, 100-count bottles, Rx only, Distributed by G.D. Searle, Division of Pfizer Inc, NY, NY 10017, NDC 0025-1031-31

  2. May 31, 2013 · Class III · Terminated · D-607-2013 · Disopyramide phosphate

    Failed Dissolution Specification

    Norpace CR (disopyramide phosphate) extended-release capsules USP,150 mg, packaged in a) 100-count bottles (NDC 0025-2742-31), and b) 500-count bottles (NDC 0025-2742-51), Rx only, Distributed by G.D. Searle LLC, Divisio

  3. April 30, 2013 · Class II · Terminated · D-425-2013 · Levothyroxine

    Subpotent Drug: The products were below specification for potency at the expiry stability point.

    Levoxyl (levothyroxine sodium) tablets, USP, 100 mcg, packaged in a) 100-count bottles (NDC 60793-854-01) and b) 1000-count bottles (NDC 60793-854-10), Rx only, Manufactured and Distributed by: King Pharmaceuticals, Inc.

  4. April 30, 2013 · Class II · Terminated · D-427-2013 · Levothyroxine

    Subpotent Drug: The products were below specification for potency at the expiry stability point.

    Levoxyl (levothyroxine sodium) tablets, USP, 125 mcg, packaged in a) 100-count bottles (NDC 60793-856-01) and b) 1000-count bottles (NDC 60793-856-10), Rx only, Manufactured and Distributed by: King Pharmaceuticals, Inc.

  5. April 30, 2013 · Class II · Terminated · D-430-2013 · Levothyroxine

    Subpotent Drug: The products were below specification for potency at the expiry stability point.

    Levoxyl (levothyroxine sodium) tablets, USP, 175 mcg, packaged in a) 100-count bottles (NDC 60793-859-01) and b) 1000-count bottles (NDC 60793-859-10), Rx only, Manufactured and Distributed by: King Pharmaceuticals, Inc.

  6. April 30, 2013 · Class II · Terminated · D-422-2013 · Levothyroxine

    Subpotent Drug: The products were below specification for potency at the expiry stability point.

    Levoxyl (levothyroxine sodium) tablets, USP, 50 mcg, packaged in a) 100-count bottles (NDC 60793-851-01) and b) 1000-count bottles (NDC 60793-851-10), Rx only, Manufactured and Distributed by: King Pharmaceuticals, Inc.,

  7. April 30, 2013 · Class II · Terminated · D-428-2013 · Levothyroxine

    Subpotent Drug: The products were below specification for potency at the expiry stability point.

    Levoxyl (levothyroxine sodium) tablets, USP, 137 mcg, packaged in a) 100-count bottles (NDC 60793-857-01) and b) 1000-count bottles (NDC 60793-857-10), Rx only, Manufactured and Distributed by: King Pharmaceuticals, Inc.

  8. April 30, 2013 · Class II · Terminated · D-426-2013 · Levothyroxine

    Subpotent Drug: The products were below specification for potency at the expiry stability point.

    Levoxyl (levothyroxine sodium) tablets, USP, 112 mcg, packaged in a) 100-count bottles (NDC 60793-855-01) and b) 1000-count bottles (NDC 60793-855-10), Rx only, Manufactured and Distributed by: King Pharmaceuticals, Inc.

  9. April 30, 2013 · Class II · Terminated · D-423-2013 · Levothyroxine

    Subpotent Drug: The products were below specification for potency at the expiry stability point.

    Levoxyl (levothyroxine sodium) tablets, USP, 75 mcg, packaged in a) 100-count bottles (NDC 60793-852-01) and b) 1000-count bottles (NDC 60793-852-10), Rx only, Manufactured and Distributed by: King Pharmaceuticals, Inc.,

  10. April 30, 2013 · Class II · Terminated · D-421-2013 · Levothyroxine

    Subpotent Drug: The products were below specification for potency at the expiry stability point.

    Levoxyl (levothyroxine sodium) tablets, USP, 25 mcg, packaged in a) 100-count bottles (NDC 60793-850-01) and b) 1000-count bottles (NDC 60793-850-10), Rx only, Manufactured and Distributed by: King Pharmaceuticals, Inc.,

  11. April 30, 2013 · Class II · Terminated · D-431-2013 · Levothyroxine

    Subpotent Drug: The products were below specification for potency at the expiry stability point.

    Levoxyl (levothyroxine sodium) tablets, USP, 200 mcg, packaged in a) 100-count bottles (NDC 60793-860-01) and b) 1000-count bottles (NDC 60793-860-10), Rx only, Manufactured and Distributed by: King Pharmaceuticals, Inc.

  12. April 30, 2013 · Class II · Terminated · D-424-2013 · Levothyroxine

    Subpotent Drug: The products were below specification for potency at the expiry stability point.

    Levoxyl (levothyroxine sodium) tablets, USP, 88 mcg, packaged in a) 100-count bottles (NDC 60793-853-01) and b) 1000-count bottles (NDC 60793-853-10), Rx only, Manufactured and Distributed by: King Pharmaceuticals, Inc.,

  13. April 30, 2013 · Class II · Terminated · D-429-2013 · Levothyroxine

    Subpotent Drug: The products were below specification for potency at the expiry stability point.

    Levoxyl (levothyroxine sodium) tablets, USP, 150 mcg, packaged in a) 100-count bottles (NDC 60793-858-01) and b) 1000-count bottles (NDC 60793-858-10), Rx only, Manufactured and Distributed by: King Pharmaceuticals, Inc.

  14. March 28, 2013 · Class II · Completed · D-257-2013 · Levothyroxine

    Chemical contamination: emission of strong odor after package was opened

    Levoxyl (levothyroxine sodium) tablets, USP 125 mcg, packaged in a) 100-count bottles (NDC 60793-856-01) and b) 1000-count bottles ( NDC 60793-856-10 ) Rx only, Manufactured and Distributed by: King Pharmaceuticals, Inc.

  15. March 28, 2013 · Class II · Completed · D-261-2013 · Levothyroxine

    Chemical contamination: emission of strong odor after package was opened.

    Levoxyl (levothyroxine sodium) tablets, USP 200 mcg, packaged in a) 100-count bottles (NDC 60793-860-01) and b) 1000-count bottles ( NDC 60793-860-10 ) Rx only, Manufactured and Distributed by: King Pharmaceuticals, Inc.

  16. March 28, 2013 · Class II · Completed · D-253-2013 · Levothyroxine

    Chemical contamination: emission of strong odor after package was opened.

    Levoxyl (levothyroxine sodium) tablets, USP 75 mcg, packaged in a) 100-count bottles (NDC 60793-852-01) and b) 1000-count bottles ( NDC 60793-852-10 ) Rx only, Manufactured and Distributed by: King Pharmaceuticals, Inc.,

  17. March 28, 2013 · Class II · Completed · D-259-2013 · Levothyroxine

    Chemical contamination: emission of strong odor after package was opened.

    Levoxyl (levothyroxine sodium) tablets, USP 150 mcg, packaged in a) 100-count bottles (NDC 60793-858-01) and b) 1000-count bottles ( NDC 60793-858-10 ) Rx only, Manufactured and Distributed by: King Pharmaceuticals, Inc.

  18. March 28, 2013 · Class II · Completed · D-251-2013 · Levothyroxine

    Chemical contamination: emission of strong odor after package was opened..

    Levoxyl (levothyroxine sodium) tablets, USP 25 mcg, packaged in a) 100-count bottles (NDC 60793-850-01) and b) 1000-count bottles ( NDC 60793-850-10 ) Rx only, Manufactured and Distributed by: King Pharmaceuticals, Inc.,

  19. March 28, 2013 · Class II · Completed · D-255-2013 · Levothyroxine

    Chemical contamination: emission of strong odor after package was opened..

    Levoxyl (levothyroxine sodium) tablets, USP 100 mcg, packaged in a) 100-count bottles (NDC 60793-854-01) and b) 1000-count bottles ( NDC 60793-854-10 ) Rx only, Manufactured and Distributed by: King Pharmaceuticals, Inc.

  20. March 28, 2013 · Class II · Completed · D-260-2013 · Levothyroxine

    Chemical contamination: emission of strong odor after package was opened.

    Levoxyl (levothyroxine sodium) tablets, USP 175 mcg, packaged in a) 100-count bottles (NDC 60793-859-01) and b) 1000-count bottles ( NDC 60793-859-10 ) Rx only, Manufactured and Distributed by: King Pharmaceuticals, Inc.

  21. March 28, 2013 · Class II · Completed · D-252-2013 · Levothyroxine

    Chemical contamination: emission of strong odor after package was opened.

    Levoxyl (levothyroxine sodium) tablets, USP 50 mcg, packaged in a) 100-count bottles (NDC 60793-851-01) and b) 1000-count bottles ( NDC 60793-851-10 ) Rx only, Manufactured and Distributed by: King Pharmaceuticals, Inc.,

  22. March 28, 2013 · Class II · Completed · D-254-2013 · Levothyroxine

    Chemical contamination: emission of strong odor after package was opened..

    Levoxyl (levothyroxine sodium) tablets, USP 88 mcg, packaged in a) 100-count bottles (NDC 60793-853-01) and b) 1000-count bottles ( NDC 60793-853-10 ) Rx only, Manufactured and Distributed by: King Pharmaceuticals, Inc.,

  23. March 28, 2013 · Class II · Completed · D-258-2013 · Levothyroxine

    Chemical contamination: emission of strong odor after package was opened.

    Levoxyl (levothyroxine sodium) tablets, USP 137 mcg, packaged in a) 100-count bottles (NDC 60793-857-01) and b) 1000-count bottles ( NDC 60793-857-10 ) Rx only, Manufactured and Distributed by: King Pharmaceuticals, Inc.

  24. March 28, 2013 · Class II · Completed · D-256-2013 · Levothyroxine

    Chemical contamination: emission of strong odor after package was opened.

    Levoxyl (levothyroxine sodium) tablets, USP 112 mcg, packaged in a) 100-count bottles (NDC 60793-855-01) and b) 1000-count bottles ( NDC 60793-855-10 ) Rx only, Manufactured and Distributed by: King Pharmaceuticals, Inc.

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

  1. NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
  2. Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
  3. Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026

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