Levoxyl Tablet
FDA Recall NDC 60793-855

FDA Enforcement Report: View Recall Date, Reasons, and Safety Status

Active & Historical Enforcement Reports

The FDA has identified 26 recorded enforcement report(s) associated with Levoxyl (NDC 60793-855). A significant event, classified as Class II, was initiated on Jul 29, 2025 by Pfizer Laboratories Div Pfizer Inc. The reported reason for this action was: "Subpotent drug"

This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.

Reported Recall Events

D-0575-2025ONGOINGD-0557-2021TERMINATEDD-0339-2019TERMINATEDD-0150-2017TERMINATEDD-423-2013TERMINATEDD-421-2013TERMINATEDD-431-2013TERMINATEDD-424-2013TERMINATEDD-429-2013TERMINATEDD-425-2013TERMINATEDD-427-2013TERMINATEDD-430-2013TERMINATEDD-422-2013TERMINATEDD-428-2013TERMINATEDD-426-2013TERMINATEDD-257-2013COMPLETEDD-261-2013COMPLETEDD-253-2013COMPLETEDD-259-2013COMPLETEDD-251-2013COMPLETEDD-255-2013COMPLETEDD-252-2013COMPLETEDD-260-2013COMPLETEDD-254-2013COMPLETEDD-258-2013COMPLETEDD-256-2013COMPLETED

July 2025 Class II Recall: Subpotent drug

Recall Number
D-0575-2025
Class II Ongoing
Reason for Recall
Subpotent drug
Initiated
Jul 29, 2025
Reported
Aug 20, 2025
Quantity
29, 004 bottles

Recall Profile & Regulatory Data

Event ID
97334
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
Pfizer
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Within U.S
Product Description
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.
Batch or Lot Expiration Information
Lot# : 24C11, Exp 2/28/2026.
Affected Packages Involved in this Recall
60793-850-10Product
60793-850-01Product
60793-851-10Product
60793-851-01Product
60793-852-10Product
60793-852-01Product
60793-853-10Product
60793-853-01Product
60793-854-10Product
60793-854-01Product
60793-855-10Product
60793-855-01Product
60793-856-10Product
60793-856-01Product
60793-857-10Product
60793-857-01Product
60793-858-10Product
60793-858-01Product
60793-859-10Product
60793-859-01Product
60793-860-10Product
60793-860-01Product

March 2021 Class II Recall: CGMP Deviations

Recall Number
D-0557-2021
Class II Terminated
Reason for Recall
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Initiated
Mar 15, 2021
Reported
Jun 02, 2021
Quantity
13 bottles

Recall Profile & Regulatory Data

Event ID
87512
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Cardinal Health Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
FL, GA, SC
Termination Date
Jun 17, 2024
Product Description
LEVOXYL Tablets, USD, 150MCG, 100-count bottle, Rx Only, Distributed by Pfizer Inc., New York, NY 10017, MADE IN AUSTRIA, NDC: 60793-858-01
Batch or Lot Expiration Information
Lot# 20D27
Affected Packages Involved in this Recall
60793-850-10Product
60793-850-01Product
60793-851-10Product
60793-851-01Product
60793-852-10Product
60793-852-01Product
60793-853-10Product
60793-853-01Product
60793-854-10Product
60793-854-01Product
60793-855-10Product
60793-855-01Product
60793-856-10Product
60793-856-01Product
60793-857-10Product
60793-857-01Product
60793-858-10Product
60793-858-01Product
60793-859-10Product
60793-859-01Product
60793-860-10Product
60793-860-01Product

December 2018 Class II Recall: Superpotent Drug.

Recall Number
D-0339-2019
Class II Terminated
Reason for Recall
Superpotent Drug.
Initiated
Dec 06, 2018
Reported
Dec 26, 2018
Quantity
1996 bottles

Recall Profile & Regulatory Data

Event ID
81731
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Pfizer Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide within the United States
Termination Date
Oct 08, 2020
Product Description
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
Batch or Lot Expiration Information
Lot# :18A18, Exp. 01/2020
Affected Packages Involved in this Recall
60793-850-10Product
60793-850-01Product
60793-851-10Product
60793-851-01Product
60793-852-10Product
60793-852-01Product
60793-853-10Product
60793-853-01Product
60793-854-10Product
60793-854-01Product
60793-855-10Product
60793-855-01Product
60793-856-10Product
60793-856-01Product
60793-857-10Product
60793-857-01Product
60793-858-10Product
60793-858-01Product
60793-859-10Product
60793-859-01Product
60793-860-10Product
60793-860-01Product

November 2016 Class II Recall: Superpotent

Recall Number
D-0150-2017
Class II Terminated
Reason for Recall
Superpotent
Initiated
Nov 07, 2016
Reported
Nov 30, 2016
Quantity
2,666 bottles

Recall Profile & Regulatory Data

Event ID
75691
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Pfizer Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide
Termination Date
May 01, 2020
Product Description
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
Batch or Lot Expiration Information
Lot# 16H21, Exp. 08/2017
Affected Packages Involved in this Recall
60793-850-10Product
60793-850-01Product
60793-851-10Product
60793-851-01Product
60793-852-10Product
60793-852-01Product
60793-853-10Product
60793-853-01Product
60793-854-10Product
60793-854-01Product
60793-855-10Product
60793-855-01Product
60793-856-10Product
60793-856-01Product
60793-857-10Product
60793-857-01Product
60793-858-10Product
60793-858-01Product
60793-859-10Product
60793-859-01Product
60793-860-10Product
60793-860-01Product

April 2013 Class II Recall: Subpotent Drug

Recall Number
D-423-2013
Class II Terminated
Reason for Recall
Subpotent Drug: The products were below specification for potency at the expiry stability point.
Initiated
Apr 30, 2013
Reported
May 29, 2013
Quantity
194,142 bottles

Recall Profile & Regulatory Data

Event ID
65172
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
King Legacy, a wholly owned subsidiary of Pfizer
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide and Puerto Rico
Termination Date
Jun 30, 2016
Product Description
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., Bristol, TN 37620
Batch or Lot Expiration Information
Lot# a) 64197, Exp. 4/13; 64339, Exp. 4/13; 65061, Exp. 5/13; 65236, Exp. 6/13; 65917, Exp. 8/13; 66122, Exp. 8/13; and 66427, Exp. 9/13; b) 64340, Exp. 4/13; 64933, Exp. 4/13; 65062, Exp. 5/13; 65237, Exp. 6/13; 65238, Exp. 6/13; and 66121, Exp. 8/13
Affected Packages Involved in this Recall
60793-850-10Product
60793-850-01Product
60793-851-10Product
60793-851-01Product
60793-852-10Product
60793-852-01Product
60793-853-10Product
60793-853-01Product
60793-854-10Product
60793-854-01Product
60793-855-10Product
60793-855-01Product
60793-856-10Product
60793-856-01Product
60793-857-10Product
60793-857-01Product
60793-858-10Product
60793-858-01Product
60793-859-10Product
60793-859-01Product
60793-860-10Product
60793-860-01Product

April 2013 Class II Recall: Subpotent Drug

Recall Number
D-421-2013
Class II Terminated
Reason for Recall
Subpotent Drug: The products were below specification for potency at the expiry stability point.
Initiated
Apr 30, 2013
Reported
May 29, 2013
Quantity
51,591 bottles

Recall Profile & Regulatory Data

Event ID
65172
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
King Legacy, a wholly owned subsidiary of Pfizer
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide and Puerto Rico
Termination Date
Jun 30, 2016
Product Description
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., Bristol, TN 37620
Batch or Lot Expiration Information
Lot# a) 65228, Exp. 06/13; 65636, Exp. 08/13; b) 65180, Exp. 05/13; 65769, Exp. 07/13
Affected Packages Involved in this Recall
60793-850-10Product
60793-850-01Product
60793-851-10Product
60793-851-01Product
60793-852-10Product
60793-852-01Product
60793-853-10Product
60793-853-01Product
60793-854-10Product
60793-854-01Product
60793-855-10Product
60793-855-01Product
60793-856-10Product
60793-856-01Product
60793-857-10Product
60793-857-01Product
60793-858-10Product
60793-858-01Product
60793-859-10Product
60793-859-01Product
60793-860-10Product
60793-860-01Product

April 2013 Class II Recall: Subpotent Drug

Recall Number
D-431-2013
Class II Terminated
Reason for Recall
Subpotent Drug: The products were below specification for potency at the expiry stability point.
Initiated
Apr 30, 2013
Reported
May 29, 2013
Quantity
33,227 bottles

Recall Profile & Regulatory Data

Event ID
65172
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
King Legacy, a wholly owned subsidiary of Pfizer
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide and Puerto Rico
Termination Date
Jun 30, 2016
Product Description
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., Bristol, TN 37620
Batch or Lot Expiration Information
Lot# a) 64301, Exp. 4/13 and 65628, Exp. 7/13; b) 64300, Exp. 4/13 and 65765, Exp. 7/13
Affected Packages Involved in this Recall
60793-850-10Product
60793-850-01Product
60793-851-10Product
60793-851-01Product
60793-852-10Product
60793-852-01Product
60793-853-10Product
60793-853-01Product
60793-854-10Product
60793-854-01Product
60793-855-10Product
60793-855-01Product
60793-856-10Product
60793-856-01Product
60793-857-10Product
60793-857-01Product
60793-858-10Product
60793-858-01Product
60793-859-10Product
60793-859-01Product
60793-860-10Product
60793-860-01Product

April 2013 Class II Recall: Subpotent Drug

Recall Number
D-424-2013
Class II Terminated
Reason for Recall
Subpotent Drug: The products were below specification for potency at the expiry stability point.
Initiated
Apr 30, 2013
Reported
May 29, 2013
Quantity
112,914 bottles

Recall Profile & Regulatory Data

Event ID
65172
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
King Legacy, a wholly owned subsidiary of Pfizer
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide and Puerto Rico
Termination Date
Jun 30, 2016
Product Description
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., Bristol, TN 37620
Batch or Lot Expiration Information
Lot# a) 64935, Exp. 5/13; 65239, Exp. 6/13; 65900, Exp. 8/13; 66370, Exp. 10/13; and 66391, Exp. 9/13; b) 64927, Exp. 5/13; and 65240, Exp. 6/13
Affected Packages Involved in this Recall
60793-850-10Product
60793-850-01Product
60793-851-10Product
60793-851-01Product
60793-852-10Product
60793-852-01Product
60793-853-10Product
60793-853-01Product
60793-854-10Product
60793-854-01Product
60793-855-10Product
60793-855-01Product
60793-856-10Product
60793-856-01Product
60793-857-10Product
60793-857-01Product
60793-858-10Product
60793-858-01Product
60793-859-10Product
60793-859-01Product
60793-860-10Product
60793-860-01Product

April 2013 Class II Recall: Subpotent Drug

Recall Number
D-429-2013
Class II Terminated
Reason for Recall
Subpotent Drug: The products were below specification for potency at the expiry stability point.
Initiated
Apr 30, 2013
Reported
May 29, 2013
Quantity
56,405 bottles

Recall Profile & Regulatory Data

Event ID
65172
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
King Legacy, a wholly owned subsidiary of Pfizer
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide and Puerto Rico
Termination Date
Jun 30, 2016
Product Description
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., Bristol, TN 37620
Batch or Lot Expiration Information
Lot# a) 65066, Exp. 5/13 and 65644, Exp. 7/13; b) 64327, Exp. 4/13 and 65772, Exp. 7/13
Affected Packages Involved in this Recall
60793-850-10Product
60793-850-01Product
60793-851-10Product
60793-851-01Product
60793-852-10Product
60793-852-01Product
60793-853-10Product
60793-853-01Product
60793-854-10Product
60793-854-01Product
60793-855-10Product
60793-855-01Product
60793-856-10Product
60793-856-01Product
60793-857-10Product
60793-857-01Product
60793-858-10Product
60793-858-01Product
60793-859-10Product
60793-859-01Product
60793-860-10Product
60793-860-01Product

April 2013 Class II Recall: Subpotent Drug

Recall Number
D-425-2013
Class II Terminated
Reason for Recall
Subpotent Drug: The products were below specification for potency at the expiry stability point.
Initiated
Apr 30, 2013
Reported
May 29, 2013
Quantity
195,201 bottles

Recall Profile & Regulatory Data

Event ID
65172
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
King Legacy, a wholly owned subsidiary of Pfizer
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide and Puerto Rico
Termination Date
Jun 30, 2016
Product Description
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., Bristol, TN 37620
Batch or Lot Expiration Information
Lot# a) 64341, Exp 04/13; 64928, Exp. 5/13; 65064, Exp. 5/13; 65233, Exp. 7/13; 66162, Exp. 8/13; 66365, Exp. 10/13; and 66677, Exp. 11/13; b) 64342, Exp. 4/13; 64929, Exp. 5/13; 65065, Exp. 5/13; 65234, Exp. 7/13; 65539, Exp. 7/13; 65901, Exp. 8/13; and 66163, Exp. 8/13
Affected Packages Involved in this Recall
60793-850-10Product
60793-850-01Product
60793-851-10Product
60793-851-01Product
60793-852-10Product
60793-852-01Product
60793-853-10Product
60793-853-01Product
60793-854-10Product
60793-854-01Product
60793-855-10Product
60793-855-01Product
60793-856-10Product
60793-856-01Product
60793-857-10Product
60793-857-01Product
60793-858-10Product
60793-858-01Product
60793-859-10Product
60793-859-01Product
60793-860-10Product
60793-860-01Product

April 2013 Class II Recall: Subpotent Drug

Recall Number
D-427-2013
Class II Terminated
Reason for Recall
Subpotent Drug: The products were below specification for potency at the expiry stability point.
Initiated
Apr 30, 2013
Reported
May 29, 2013
Quantity
103,796 bottles

Recall Profile & Regulatory Data

Event ID
65172
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
King Legacy, a wholly owned subsidiary of Pfizer
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide and Puerto Rico
Termination Date
Jun 30, 2016
Product Description
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., Bristol, TN 37620
Batch or Lot Expiration Information
Lot# a) 64333, Exp. 5/13; 64937, Exp. 6/13; 65629, Exp. 7/13; and 66296, Exp. 9/13; b) 64931, Exp. 5/13 and 65766, Exp. 7/13
Affected Packages Involved in this Recall
60793-850-10Product
60793-850-01Product
60793-851-10Product
60793-851-01Product
60793-852-10Product
60793-852-01Product
60793-853-10Product
60793-853-01Product
60793-854-10Product
60793-854-01Product
60793-855-10Product
60793-855-01Product
60793-856-10Product
60793-856-01Product
60793-857-10Product
60793-857-01Product
60793-858-10Product
60793-858-01Product
60793-859-10Product
60793-859-01Product
60793-860-10Product
60793-860-01Product

April 2013 Class II Recall: Subpotent Drug

Recall Number
D-430-2013
Class II Terminated
Reason for Recall
Subpotent Drug: The products were below specification for potency at the expiry stability point.
Initiated
Apr 30, 2013
Reported
May 29, 2013
Quantity
51,438 bottles

Recall Profile & Regulatory Data

Event ID
65172
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
King Legacy, a wholly owned subsidiary of Pfizer
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide and Puerto Rico
Termination Date
Jun 30, 2016
Product Description
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., Bristol, TN 37620
Batch or Lot Expiration Information
Lot# a) 64329, Exp. 5/13; 65229, Exp. 6/13; and 65913, Exp. 9/13; b) 64330, Exp. 5/13; 65230, Exp. 6/13; and 65915, Exp. 9/13
Affected Packages Involved in this Recall
60793-850-10Product
60793-850-01Product
60793-851-10Product
60793-851-01Product
60793-852-10Product
60793-852-01Product
60793-853-10Product
60793-853-01Product
60793-854-10Product
60793-854-01Product
60793-855-10Product
60793-855-01Product
60793-856-10Product
60793-856-01Product
60793-857-10Product
60793-857-01Product
60793-858-10Product
60793-858-01Product
60793-859-10Product
60793-859-01Product
60793-860-10Product
60793-860-01Product

April 2013 Class II Recall: Subpotent Drug

Recall Number
D-422-2013
Class II Terminated
Reason for Recall
Subpotent Drug: The products were below specification for potency at the expiry stability point.
Initiated
Apr 30, 2013
Reported
May 29, 2013
Quantity
195,699 bottles

Recall Profile & Regulatory Data

Event ID
65172
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
King Legacy, a wholly owned subsidiary of Pfizer
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide and Puerto Rico
Termination Date
Jun 30, 2016
Product Description
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., Bristol, TN 37620
Batch or Lot Expiration Information
Lot# a) 64934, Exp. 4/13; 65059, Exp. 5/13; 65179, Exp. 4/13; 65630, Exp. 7/13; 65916, Exp. 8/13; 66367, Exp. 10/13; and 66718, Exp. 11/13; b) 64338, Exp. 4/13; 64932, Exp. 4/13; 65060, Exp. 5/13; 65235, Exp. 6/13; 65853, Exp. 6/13; and 65962, Exp. 7/13
Affected Packages Involved in this Recall
60793-850-10Product
60793-850-01Product
60793-851-10Product
60793-851-01Product
60793-852-10Product
60793-852-01Product
60793-853-10Product
60793-853-01Product
60793-854-10Product
60793-854-01Product
60793-855-10Product
60793-855-01Product
60793-856-10Product
60793-856-01Product
60793-857-10Product
60793-857-01Product
60793-858-10Product
60793-858-01Product
60793-859-10Product
60793-859-01Product
60793-860-10Product
60793-860-01Product

April 2013 Class II Recall: Subpotent Drug

Recall Number
D-428-2013
Class II Terminated
Reason for Recall
Subpotent Drug: The products were below specification for potency at the expiry stability point.
Initiated
Apr 30, 2013
Reported
May 29, 2013
Quantity
77,272 bottles

Recall Profile & Regulatory Data

Event ID
65172
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
King Legacy, a wholly owned subsidiary of Pfizer
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide and Puerto Rico
Termination Date
Jun 30, 2016
Product Description
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., Bristol, TN 37620
Batch or Lot Expiration Information
Lot# a) 64190, Exp. 4/13; 64331, Exp. 6/13; 65642, Exp. 7/13; and 66297, Exp. 9/13; b) 64326, Exp. 4/13; 64332, Exp. 6/13; and 65771, Exp. 7/13
Affected Packages Involved in this Recall
60793-850-10Product
60793-850-01Product
60793-851-10Product
60793-851-01Product
60793-852-10Product
60793-852-01Product
60793-853-10Product
60793-853-01Product
60793-854-10Product
60793-854-01Product
60793-855-10Product
60793-855-01Product
60793-856-10Product
60793-856-01Product
60793-857-10Product
60793-857-01Product
60793-858-10Product
60793-858-01Product
60793-859-10Product
60793-859-01Product
60793-860-10Product
60793-860-01Product

April 2013 Class II Recall: Subpotent Drug

Recall Number
D-426-2013
Class II Terminated
Reason for Recall
Subpotent Drug: The products were below specification for potency at the expiry stability point.
Initiated
Apr 30, 2013
Reported
May 29, 2013
Quantity
107,236 bottles

Recall Profile & Regulatory Data

Event ID
65172
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
King Legacy, a wholly owned subsidiary of Pfizer
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide and Puerto Rico
Termination Date
Jun 30, 2016
Product Description
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., Bristol, TN 37620
Batch or Lot Expiration Information
Lot# a) 64936, Exp. 5/13; 65634, Exp. 7/13; 66295, Exp. 9/13; 66669, Exp. 11/13; b) 65063, Exp. 5/13 and 65767, Exp. 7/13
Affected Packages Involved in this Recall
60793-850-10Product
60793-850-01Product
60793-851-10Product
60793-851-01Product
60793-852-10Product
60793-852-01Product
60793-853-10Product
60793-853-01Product
60793-854-10Product
60793-854-01Product
60793-855-10Product
60793-855-01Product
60793-856-10Product
60793-856-01Product
60793-857-10Product
60793-857-01Product
60793-858-10Product
60793-858-01Product
60793-859-10Product
60793-859-01Product
60793-860-10Product
60793-860-01Product

March 2013 Class II Recall: Chemical contamination

Recall Number
D-257-2013
Class II Completed
Reason for Recall
Chemical contamination: emission of strong odor after package was opened
Initiated
Mar 28, 2013
Reported
Apr 24, 2013
Quantity
37891 bottles

Recall Profile & Regulatory Data

Event ID
64835
Classification
Class II
Enforcement Status
Completed
Recalling Firm
Pfizer Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide and PR
Product Description
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., Bristol, TN 37620.
Batch or Lot Expiration Information
Lot# a) 66373B, Exp. 10/13; 66851B, Exp. 12/13; b)66792B, Exp. 12/13; 67349B, Exp. 03/14
Affected Packages Involved in this Recall
60793-850-10Product
60793-850-01Product
60793-851-10Product
60793-851-01Product
60793-852-10Product
60793-852-01Product
60793-853-10Product
60793-853-01Product
60793-854-10Product
60793-854-01Product
60793-855-10Product
60793-855-01Product
60793-856-10Product
60793-856-01Product
60793-857-10Product
60793-857-01Product
60793-858-10Product
60793-858-01Product
60793-859-10Product
60793-859-01Product
60793-860-10Product
60793-860-01Product

March 2013 Class II Recall: Chemical contamination

Recall Number
D-261-2013
Class II Completed
Reason for Recall
Chemical contamination: emission of strong odor after package was opened.
Initiated
Mar 28, 2013
Reported
Apr 24, 2013
Quantity
14464 bottles

Recall Profile & Regulatory Data

Event ID
64835
Classification
Class II
Enforcement Status
Completed
Recalling Firm
Pfizer Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide and PR
Product Description
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., Bristol, TN 37620.
Batch or Lot Expiration Information
Lot# a) 66671B, Exp. 11/13; 67512B, Exp. 02/14 b) 66739B Exp. 11/13; 67513B Exp. 02/14
Affected Packages Involved in this Recall
60793-850-10Product
60793-850-01Product
60793-851-10Product
60793-851-01Product
60793-852-10Product
60793-852-01Product
60793-853-10Product
60793-853-01Product
60793-854-10Product
60793-854-01Product
60793-855-10Product
60793-855-01Product
60793-856-10Product
60793-856-01Product
60793-857-10Product
60793-857-01Product
60793-858-10Product
60793-858-01Product
60793-859-10Product
60793-859-01Product
60793-860-10Product
60793-860-01Product

March 2013 Class II Recall: Chemical contamination

Recall Number
D-253-2013
Class II Completed
Reason for Recall
Chemical contamination: emission of strong odor after package was opened.
Initiated
Mar 28, 2013
Reported
Apr 24, 2013
Quantity
37809 bottles

Recall Profile & Regulatory Data

Event ID
64835
Classification
Class II
Enforcement Status
Completed
Recalling Firm
Pfizer Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide and PR
Product Description
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., Bristol, TN 37620.
Batch or Lot Expiration Information
Lot# a) 66369B, Exp. 10/13; 66679B, Exp. 11/13; 66850B, Exp. 12/13; b) 66676B, 66732B, Exp. 12/13; 67136B, Exp. 03/14
Affected Packages Involved in this Recall
60793-850-10Product
60793-850-01Product
60793-851-10Product
60793-851-01Product
60793-852-10Product
60793-852-01Product
60793-853-10Product
60793-853-01Product
60793-854-10Product
60793-854-01Product
60793-855-10Product
60793-855-01Product
60793-856-10Product
60793-856-01Product
60793-857-10Product
60793-857-01Product
60793-858-10Product
60793-858-01Product
60793-859-10Product
60793-859-01Product
60793-860-10Product
60793-860-01Product

March 2013 Class II Recall: Chemical contamination

Recall Number
D-259-2013
Class II Completed
Reason for Recall
Chemical contamination: emission of strong odor after package was opened.
Initiated
Mar 28, 2013
Reported
Apr 24, 2013
Quantity
36045 bottles

Recall Profile & Regulatory Data

Event ID
64835
Classification
Class II
Enforcement Status
Completed
Recalling Firm
Pfizer Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide and PR
Product Description
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., Bristol, TN 37620.
Batch or Lot Expiration Information
Lot# a) 66375B, Exp. 10/13; 66719B, Exp. 01/14; b) 66904B, Exp. 01/14
Affected Packages Involved in this Recall
60793-850-10Product
60793-850-01Product
60793-851-10Product
60793-851-01Product
60793-852-10Product
60793-852-01Product
60793-853-10Product
60793-853-01Product
60793-854-10Product
60793-854-01Product
60793-855-10Product
60793-855-01Product
60793-856-10Product
60793-856-01Product
60793-857-10Product
60793-857-01Product
60793-858-10Product
60793-858-01Product
60793-859-10Product
60793-859-01Product
60793-860-10Product
60793-860-01Product

March 2013 Class II Recall: Chemical contamination

Recall Number
D-251-2013
Class II Completed
Reason for Recall
Chemical contamination: emission of strong odor after package was opened..
Initiated
Mar 28, 2013
Reported
Apr 24, 2013
Quantity
23210 bottles

Recall Profile & Regulatory Data

Event ID
64835
Classification
Class II
Enforcement Status
Completed
Recalling Firm
Pfizer Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide and PR
Product Description
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., Bristol, TN 37620.
Batch or Lot Expiration Information
Lot# a) 66675B, Exp. 10/13; b) 66852B Exp. 10/13; 67138B, Exp. 02/14
Affected Packages Involved in this Recall
60793-850-10Product
60793-850-01Product
60793-851-10Product
60793-851-01Product
60793-852-10Product
60793-852-01Product
60793-853-10Product
60793-853-01Product
60793-854-10Product
60793-854-01Product
60793-855-10Product
60793-855-01Product
60793-856-10Product
60793-856-01Product
60793-857-10Product
60793-857-01Product
60793-858-10Product
60793-858-01Product
60793-859-10Product
60793-859-01Product
60793-860-10Product
60793-860-01Product

March 2013 Class II Recall: Chemical contamination

Recall Number
D-255-2013
Class II Completed
Reason for Recall
Chemical contamination: emission of strong odor after package was opened..
Initiated
Mar 28, 2013
Reported
Apr 24, 2013
Quantity
18195 bottles

Recall Profile & Regulatory Data

Event ID
64835
Classification
Class II
Enforcement Status
Completed
Recalling Firm
Pfizer Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide and PR
Product Description
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., Bristol, TN 37620.
Batch or Lot Expiration Information
Lot# a) 66897B, Exp. 12/13; b) 67137B, Exp.02/14
Affected Packages Involved in this Recall
60793-850-10Product
60793-850-01Product
60793-851-10Product
60793-851-01Product
60793-852-10Product
60793-852-01Product
60793-853-10Product
60793-853-01Product
60793-854-10Product
60793-854-01Product
60793-855-10Product
60793-855-01Product
60793-856-10Product
60793-856-01Product
60793-857-10Product
60793-857-01Product
60793-858-10Product
60793-858-01Product
60793-859-10Product
60793-859-01Product
60793-860-10Product
60793-860-01Product

March 2013 Class II Recall: Chemical contamination

Recall Number
D-252-2013
Class II Completed
Reason for Recall
Chemical contamination: emission of strong odor after package was opened.
Initiated
Mar 28, 2013
Reported
Apr 24, 2013
Quantity
29613 bottles

Recall Profile & Regulatory Data

Event ID
64835
Classification
Class II
Enforcement Status
Completed
Recalling Firm
Pfizer Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide and PR
Product Description
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., Bristol, TN 37620.
Batch or Lot Expiration Information
Lot# a) 66730B, 66853B, Exp. 01/14; b) 66731B, 67116B, Exp. 11/13, 66856B, Exp. 12/13; 67341B, Exp, 02/14
Affected Packages Involved in this Recall
60793-850-10Product
60793-850-01Product
60793-851-10Product
60793-851-01Product
60793-852-10Product
60793-852-01Product
60793-853-10Product
60793-853-01Product
60793-854-10Product
60793-854-01Product
60793-855-10Product
60793-855-01Product
60793-856-10Product
60793-856-01Product
60793-857-10Product
60793-857-01Product
60793-858-10Product
60793-858-01Product
60793-859-10Product
60793-859-01Product
60793-860-10Product
60793-860-01Product

March 2013 Class II Recall: Chemical contamination

Recall Number
D-260-2013
Class II Completed
Reason for Recall
Chemical contamination: emission of strong odor after package was opened.
Initiated
Mar 28, 2013
Reported
Apr 24, 2013
Quantity
10121 bottles

Recall Profile & Regulatory Data

Event ID
64835
Classification
Class II
Enforcement Status
Completed
Recalling Firm
Pfizer Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide and PR
Product Description
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., Bristol, TN 37620.
Batch or Lot Expiration Information
Lot# a) 67507B, Exp. 02/14; b) 67508B, Exp. 02/14
Affected Packages Involved in this Recall
60793-850-10Product
60793-850-01Product
60793-851-10Product
60793-851-01Product
60793-852-10Product
60793-852-01Product
60793-853-10Product
60793-853-01Product
60793-854-10Product
60793-854-01Product
60793-855-10Product
60793-855-01Product
60793-856-10Product
60793-856-01Product
60793-857-10Product
60793-857-01Product
60793-858-10Product
60793-858-01Product
60793-859-10Product
60793-859-01Product
60793-860-10Product
60793-860-01Product

March 2013 Class II Recall: Chemical contamination

Recall Number
D-254-2013
Class II Completed
Reason for Recall
Chemical contamination: emission of strong odor after package was opened..
Initiated
Mar 28, 2013
Reported
Apr 24, 2013
Quantity
26447 bottles

Recall Profile & Regulatory Data

Event ID
64835
Classification
Class II
Enforcement Status
Completed
Recalling Firm
Pfizer Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide and PR
Product Description
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., Bristol, TN 37620.
Batch or Lot Expiration Information
Lot# a) 66619B, Exp. 11/13; 67010B, Exp. 01/14; b) 66733B, Exp. 11/13; 67441B, Exp. 01/14
Affected Packages Involved in this Recall
60793-850-10Product
60793-850-01Product
60793-851-10Product
60793-851-01Product
60793-852-10Product
60793-852-01Product
60793-853-10Product
60793-853-01Product
60793-854-10Product
60793-854-01Product
60793-855-10Product
60793-855-01Product
60793-856-10Product
60793-856-01Product
60793-857-10Product
60793-857-01Product
60793-858-10Product
60793-858-01Product
60793-859-10Product
60793-859-01Product
60793-860-10Product
60793-860-01Product

March 2013 Class II Recall: Chemical contamination

Recall Number
D-258-2013
Class II Completed
Reason for Recall
Chemical contamination: emission of strong odor after package was opened.
Initiated
Mar 28, 2013
Reported
Apr 24, 2013
Quantity
7901 bottles

Recall Profile & Regulatory Data

Event ID
64835
Classification
Class II
Enforcement Status
Completed
Recalling Firm
Pfizer Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide and PR
Product Description
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., Bristol, TN 37620.
Batch or Lot Expiration Information
Lot# a) 67013B, Exp. 01/14; b) 66900B, Exp. 01/14
Affected Packages Involved in this Recall
60793-850-10Product
60793-850-01Product
60793-851-10Product
60793-851-01Product
60793-852-10Product
60793-852-01Product
60793-853-10Product
60793-853-01Product
60793-854-10Product
60793-854-01Product
60793-855-10Product
60793-855-01Product
60793-856-10Product
60793-856-01Product
60793-857-10Product
60793-857-01Product
60793-858-10Product
60793-858-01Product
60793-859-10Product
60793-859-01Product
60793-860-10Product
60793-860-01Product

March 2013 Class II Recall: Chemical contamination

Recall Number
D-256-2013
Class II Completed
Reason for Recall
Chemical contamination: emission of strong odor after package was opened.
Initiated
Mar 28, 2013
Reported
Apr 24, 2013
Quantity
9213 bottles

Recall Profile & Regulatory Data

Event ID
64835
Classification
Class II
Enforcement Status
Completed
Recalling Firm
Pfizer Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide and PR
Product Description
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., Bristol, TN 37620.
Batch or Lot Expiration Information
Lot# a) 67343B, Exp. 01/14; b) 66902B, Exp. 12/13
Affected Packages Involved in this Recall
60793-850-10Product
60793-850-01Product
60793-851-10Product
60793-851-01Product
60793-852-10Product
60793-852-01Product
60793-853-10Product
60793-853-01Product
60793-854-10Product
60793-854-01Product
60793-855-10Product
60793-855-01Product
60793-856-10Product
60793-856-01Product
60793-857-10Product
60793-857-01Product
60793-858-10Product
60793-858-01Product
60793-859-10Product
60793-859-01Product
60793-860-10Product
60793-860-01Product

About FDA Recall Enforcement Reports

FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.

If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.