Synthroid Tablet
FDA Recall NDC 0074-9296

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

Active & Historical Enforcement Reports

The FDA has identified 5 recorded enforcement report(s) associated with Synthroid (NDC 0074-9296). A significant event, classified as Class III, was initiated on Oct 17, 2023 by Abbvie Inc.. The reported reason for this action was: "Labeling: Wrong Barcode- One (1) of every forty (40) unit dose blister will contain incorrect barcode information that causes a 125mcg unit dose is scanned as 200mcg unit dose."

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-0088-2024ONGOINGD-107-2013TERMINATEDD-1695-2012TERMINATEDD-1696-2012TERMINATEDD-1694-2012TERMINATED

October 2023 Class III Recall: Labeling

Recall Number
D-0088-2024
Class III Ongoing
Reason for Recall
Labeling: Wrong Barcode- One (1) of every forty (40) unit dose blister will contain incorrect barcode information that causes a 125mcg unit dose is scanned as 200mcg unit dose.
Initiated
Oct 17, 2023
Reported
Nov 15, 2023
Quantity
864 cartons

Recall Profile & Regulatory Data

Event ID
93202
Classification
Class III
Enforcement Status
Ongoing
Recalling Firm
AbbVie Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Distributed in the US. No government or foreign consignees.
Product Description
Synthroid, Levothyroxine Sodium Tablets, USP 125mcg (0.125mg), 100-count bottle, Rx Only AbbVie Inc. North Chicago, IL 60064, U.S.A. NDC 0074-7068-11
Batch or Lot Expiration Information
Lot# 1187435 exp date: 02/2024
Affected Packages Involved in this Recall
0074-4341-13Product
0074-4341-90Product
0074-4341-19Product
0074-4341-72Product
0074-4552-13Product
0074-4552-90Product
0074-4552-19Product
0074-4552-11Product
0074-4552-71Product
0074-4552-72Product
0074-5182-13Product
0074-5182-90Product
0074-5182-71Product
0074-5182-19Product
0074-5182-11Product
0074-5182-72Product
0074-6594-13Product
0074-6594-90Product
0074-6594-71Product
0074-6594-19Product
0074-6594-72Product
0074-6624-13Product
0074-6624-90Product
0074-6624-19Product
0074-6624-11Product
0074-6624-71Product
0074-6624-72Product
0074-9296-13Product
0074-9296-90Product
0074-9296-19Product
0074-9296-71Product
0074-9296-72Product
0074-7068-13Product
0074-7068-90Product
0074-7068-71Product
0074-7068-19Product
0074-7068-11Product
0074-7068-72Product
0074-3727-13Product
0074-3727-90Product
0074-3727-71Product
0074-3727-19Product
0074-3727-72Product
0074-7069-90Product
0074-7069-71Product
0074-7069-19Product
0074-7069-11Product
0074-7069-72Product
0074-7070-13Product
0074-7070-90Product
0074-7070-71Product
0074-7070-19Product
0074-7070-72Product
0074-7148-90Product
0074-7148-19Product
0074-7148-71Product
0074-7148-11Product
0074-7148-72Product
0074-7149-90Product
0074-7149-19Product

December 2012 Class II Recall: Labeling

Recall Number
D-107-2013
Class II Terminated
Reason for Recall
Labeling: Error on Declared Strength. Product labeled to contain 150 mcg tablets actually contained 75 mcg tablets.
Initiated
Dec 04, 2012
Reported
Jan 09, 2013
Quantity
28, 524 bottles

Recall Profile & Regulatory Data

Event ID
63791
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Abbott Laboratories
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
US Nationwide and Puerto Rico
Termination Date
Jul 10, 2015
Product Description
Synthroid (Levothyroxine Sodium) tablets, 150 mcg (0.15 mg), 90 tablets per bottle, Rx Only, NDC 0074-7069-90; ABBOTT LABORATORIES NORTH CHICAGO, IL 60064 U.S.A.
Batch or Lot Expiration Information
Lot# 18262A8 Exp. 09/13
Affected Packages Involved in this Recall
0074-4341-13Product
0074-4341-90Product
0074-4341-19Product
0074-4341-72Product
0074-4552-13Product
0074-4552-90Product
0074-4552-19Product
0074-4552-11Product
0074-4552-71Product
0074-4552-72Product
0074-5182-13Product
0074-5182-90Product
0074-5182-71Product
0074-5182-19Product
0074-5182-11Product
0074-5182-72Product
0074-6594-13Product
0074-6594-90Product
0074-6594-71Product
0074-6594-19Product
0074-6594-72Product
0074-6624-13Product
0074-6624-90Product
0074-6624-19Product
0074-6624-11Product
0074-6624-71Product
0074-6624-72Product
0074-9296-13Product
0074-9296-90Product
0074-9296-19Product
0074-9296-71Product
0074-9296-72Product
0074-7068-13Product
0074-7068-90Product
0074-7068-71Product
0074-7068-19Product
0074-7068-11Product
0074-7068-72Product
0074-3727-13Product
0074-3727-90Product
0074-3727-71Product
0074-3727-19Product
0074-3727-72Product
0074-7069-90Product
0074-7069-71Product
0074-7069-19Product
0074-7069-11Product
0074-7069-72Product
0074-7070-13Product
0074-7070-90Product
0074-7070-71Product
0074-7070-19Product
0074-7070-72Product
0074-7148-90Product
0074-7148-19Product
0074-7148-71Product
0074-7148-11Product
0074-7148-72Product
0074-7149-90Product
0074-7149-19Product

July 2012 Class II Recall: Defective Container

Recall Number
D-1695-2012
Class II Terminated
Reason for Recall
Defective Container: A number of Synthroid bottles have a localized thin wall defect on the bottom which may potentially impact the stability of the tablets.
Initiated
Jul 19, 2012
Reported
Oct 03, 2012
Quantity
42,596 Bottles

Recall Profile & Regulatory Data

Event ID
62674
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Abbott Laboratories
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide
Termination Date
Nov 01, 2013
Product Description
Synthroid (levothyroxine sodium) Tablets USP, 75 mcg, Rx Only, 90-Count Bottle, Abbott Laboratories, North Chicago, IL 60064, NDC: 0074-5182-90.
Batch or Lot Expiration Information
Lot# Lot: 18353A8, Exp 08/31/2013
Affected Packages Involved in this Recall
0074-4341-13Product
0074-4341-90Product
0074-4341-19Product
0074-4341-72Product
0074-4552-13Product
0074-4552-90Product
0074-4552-19Product
0074-4552-11Product
0074-4552-71Product
0074-4552-72Product
0074-5182-13Product
0074-5182-90Product
0074-5182-71Product
0074-5182-19Product
0074-5182-11Product
0074-5182-72Product
0074-6594-13Product
0074-6594-90Product
0074-6594-71Product
0074-6594-19Product
0074-6594-72Product
0074-6624-13Product
0074-6624-90Product
0074-6624-19Product
0074-6624-11Product
0074-6624-71Product
0074-6624-72Product
0074-9296-13Product
0074-9296-90Product
0074-9296-19Product
0074-9296-71Product
0074-9296-72Product
0074-7068-13Product
0074-7068-90Product
0074-7068-71Product
0074-7068-19Product
0074-7068-11Product
0074-7068-72Product
0074-3727-13Product
0074-3727-90Product
0074-3727-71Product
0074-3727-19Product
0074-3727-72Product
0074-7069-90Product
0074-7069-71Product
0074-7069-19Product
0074-7069-11Product
0074-7069-72Product
0074-7070-13Product
0074-7070-90Product
0074-7070-71Product
0074-7070-19Product
0074-7070-72Product
0074-7148-90Product
0074-7148-19Product
0074-7148-71Product
0074-7148-11Product
0074-7148-72Product
0074-7149-90Product
0074-7149-19Product

July 2012 Class II Recall: Defective Container

Recall Number
D-1696-2012
Class II Terminated
Reason for Recall
Defective Container: A number of Synthroid bottles have a localized thin wall defect on the bottom which may potentially impact the stability of the tablets.
Initiated
Jul 19, 2012
Reported
Oct 03, 2012
Quantity
40,464 Bottles

Recall Profile & Regulatory Data

Event ID
62674
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Abbott Laboratories
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide
Termination Date
Nov 01, 2013
Product Description
Synthroid (levothyroxine sodium) Tablets USP, 112 mcg, Rx Only, 90-Count Bottle, Abbott Laboratories, North Chicago, IL 60064, NDC: 0074-9296-90
Batch or Lot Expiration Information
Lot# Lot: 18355A8, Exp. 09/26/13
Affected Packages Involved in this Recall
0074-4341-13Product
0074-4341-90Product
0074-4341-19Product
0074-4341-72Product
0074-4552-13Product
0074-4552-90Product
0074-4552-19Product
0074-4552-11Product
0074-4552-71Product
0074-4552-72Product
0074-5182-13Product
0074-5182-90Product
0074-5182-71Product
0074-5182-19Product
0074-5182-11Product
0074-5182-72Product
0074-6594-13Product
0074-6594-90Product
0074-6594-71Product
0074-6594-19Product
0074-6594-72Product
0074-6624-13Product
0074-6624-90Product
0074-6624-19Product
0074-6624-11Product
0074-6624-71Product
0074-6624-72Product
0074-9296-13Product
0074-9296-90Product
0074-9296-19Product
0074-9296-71Product
0074-9296-72Product
0074-7068-13Product
0074-7068-90Product
0074-7068-71Product
0074-7068-19Product
0074-7068-11Product
0074-7068-72Product
0074-3727-13Product
0074-3727-90Product
0074-3727-71Product
0074-3727-19Product
0074-3727-72Product
0074-7069-90Product
0074-7069-71Product
0074-7069-19Product
0074-7069-11Product
0074-7069-72Product
0074-7070-13Product
0074-7070-90Product
0074-7070-71Product
0074-7070-19Product
0074-7070-72Product
0074-7148-90Product
0074-7148-19Product
0074-7148-71Product
0074-7148-11Product
0074-7148-72Product
0074-7149-90Product
0074-7149-19Product

July 2012 Class II Recall: Defective Container

Recall Number
D-1694-2012
Class II Terminated
Reason for Recall
Defective Container: A number of Synthroid bottles have a localized thin wall defect on the bottom which may potentially impact the stability of the tablets.
Initiated
Jul 19, 2012
Reported
Oct 03, 2012
Quantity
53,448 Bottles

Recall Profile & Regulatory Data

Event ID
62674
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Abbott Laboratories
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide
Termination Date
Nov 01, 2013
Product Description
Synthroid (levothyroxine sodium) Tablets USP, 50 mcg, Rx Only, 90-Count Bottle, Abbott Laboratories, North Chicago, IL 60064, NDC: 0074-4552-90.
Batch or Lot Expiration Information
Lot# 18265A8, Exp 09/20/2013
Affected Packages Involved in this Recall
0074-4341-13Product
0074-4341-90Product
0074-4341-19Product
0074-4341-72Product
0074-4552-13Product
0074-4552-90Product
0074-4552-19Product
0074-4552-11Product
0074-4552-71Product
0074-4552-72Product
0074-5182-13Product
0074-5182-90Product
0074-5182-71Product
0074-5182-19Product
0074-5182-11Product
0074-5182-72Product
0074-6594-13Product
0074-6594-90Product
0074-6594-71Product
0074-6594-19Product
0074-6594-72Product
0074-6624-13Product
0074-6624-90Product
0074-6624-19Product
0074-6624-11Product
0074-6624-71Product
0074-6624-72Product
0074-9296-13Product
0074-9296-90Product
0074-9296-19Product
0074-9296-71Product
0074-9296-72Product
0074-7068-13Product
0074-7068-90Product
0074-7068-71Product
0074-7068-19Product
0074-7068-11Product
0074-7068-72Product
0074-3727-13Product
0074-3727-90Product
0074-3727-71Product
0074-3727-19Product
0074-3727-72Product
0074-7069-90Product
0074-7069-71Product
0074-7069-19Product
0074-7069-11Product
0074-7069-72Product
0074-7070-13Product
0074-7070-90Product
0074-7070-71Product
0074-7070-19Product
0074-7070-72Product
0074-7148-90Product
0074-7148-19Product
0074-7148-71Product
0074-7148-11Product
0074-7148-72Product
0074-7149-90Product
0074-7149-19Product

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.