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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

Drug Recall

Official source record

Recall number
D-0088-2024
Event ID
93202
Classification
Class III
Status
Ongoing
Recalling company
AbbVie Inc.
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.
Report date
November 15, 2023
Recall initiation date
October 17, 2023
Termination date
Not terminated as of this source record
Distribution pattern
Distributed in the US. No government or foreign consignees.

Drug product identifiers

Manufacturer
AbbVie Inc.
Brand name
SYNTHROID
Generic name
LEVOTHYROXINE SODIUM
Substance name
LEVOTHYROXINE SODIUM
Product NDCs
0074-3727; 0074-4341; 0074-4552; 0074-5182; 0074-6594; 0074-6624; 0074-7068; 0074-7069; 0074-7070; 0074-7148; 0074-7149; 0074-9296
Package NDCs
0074-3727-13; 0074-3727-19; 0074-3727-71; 0074-3727-72; 0074-3727-90; 0074-4341-13; 0074-4341-19; 0074-4341-72; 0074-4341-90; 0074-4552-11; 0074-4552-13; 0074-4552-19; 0074-4552-71; 0074-4552-72; 0074-4552-90; 0074-5182-11; 0074-5182-13; 0074-5182-19; 0074-5182-71; 0074-5182-72; 0074-5182-90; 0074-6594-13; 0074-6594-19; 0074-6594-71; 0074-6594-72; 0074-6594-90; 0074-6624-11; 0074-6624-13; 0074-6624-19; 0074-6624-71; 0074-6624-72; 0074-6624-90; 0074-7068-11; 0074-7068-13; 0074-7068-19; 0074-7068-71; 0074-7068-72; 0074-7068-90; 0074-7069-11; 0074-7069-19; 0074-7069-71; 0074-7069-72; 0074-7069-90; 0074-7070-13; 0074-7070-19; 0074-7070-71; 0074-7070-72; 0074-7070-90; 0074-7148-11; 0074-7148-19; 0074-7148-71; 0074-7148-72; 0074-7148-90; 0074-7149-19; 0074-7149-90; 0074-9296-13; 0074-9296-19; 0074-9296-71; 0074-9296-72; 0074-9296-90
Route
ORAL

Where this information comes from

View FDA enforcement record -- the specific openFDA drug enforcement record this summary was built from.

FDA Enforcement Reports -- FDA's general, official recall and enforcement information.

Drug recall information is sourced from the FDA's structured openFDA Enforcement Reports. Newly announced recalls may appear on FDA.gov before they become available in the structured dataset. See Methodology for details.

Retrieved by Public Health Trace:

Frequently asked questions

What does a Class III mean?

A situation in which use of or exposure to a product is not likely to cause adverse health consequences.

Is this recall still active?

According to the FDA, this recall's status is "Ongoing." Always confirm the current status using the source links below, since status can change after Public Health Trace last retrieved this record.

What should I do if I have this medication?

Do not start, stop, or change any medication based on this page. Follow the instructions published by the FDA and the recalling company (see the source links below), and talk to your pharmacist or physician if you have questions about a specific medication.

Where can I find more official information?

The source links below, published by the FDA, are the authoritative record for this recall, including any updates issued after this summary was retrieved.

Public Health Trace republishes official FDA drug recall information -- it is not affiliated with the FDA, does not verify or supplement what the source has published, and does not provide medical advice. Never start, stop, or change a medication based on this page. Always follow the guidance of your pharmacist or physician, and consult the official source links above for the most current information. Read the full medical disclaimer.