Independent register of U.S. FDA drug recalls · updated Oct 10, 2026
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Class III · Low risk Ongoing Initiated Oct 17, 2023 (3 years ago)

Synthroid (Levothyroxine Sodium)

Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.

Why it was recalled

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.

Cause type: Labeling / mix-up

Wrong label, wrong strength, mixed-up products, or packaging errors. One of the most dangerous causes - you can end up taking the wrong drug or the wrong dose. All labeling / mix-up recalls.

What was recalled

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

Affected NDC 0074-7068-11

Compare with the code on your package — it is the most precise check available.

Drug: Levothyroxine Category: Thyroid Medication

Product details

From the FDA NDC directory, for the product code this recall names. Compare with the label on your package.

ProductStrengthForm & routeLabelerType
Synthroid
Levothyroxine Sodium
NDC 00074-7068
125 ug/1 Tablet
Oral
AbbVie Inc. Rx
Recalling firm
AbbVie Inc.
NDC code
0074-7068-11
Origin
IL, United States
Initiated by
Voluntary: Firm initiated
FDA recall number
D-0088-2024 · FDA notice

Low risk, still worth a check. Class III means the product is unlikely to cause harm but breaks an FDA rule (often labeling). If your lot matches, your pharmacy will normally swap it; there is no need for alarm.

Other Levothyroxine recalls

See all

Other recalls by AbbVie Inc.

All 2023 recalls
Class II · Moderate risk

Refresh P.M.

Lack of Assurance of Sterility: The impacted lots may contain a breach in the tube seal.

Ongoing Sterility / contamination AbbVie Inc. D-0664-2024
Class III · Low risk

Ultane (sevoflurane)

Defective container: presence of a hole in the liners of the caps covering the product bottle, introducing possibility of leakage.

Terminated Packaging defect AbbVie Inc. NDC 0074-4456-51 D-0412-2018