Synthroid (levothyroxine sodium)
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.
Yes — there is an active recall. 62 ongoing FDA recalls mention Levothyroxine (186 total). Check the affected lots below.
Recalls are matched by product description. A recall usually affects specific lots, not every package of Levothyroxine. “Active” means an FDA recall is still ongoing; “closed” means it was terminated or completed. Checked against openFDA on Oct 10, 2026.
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.
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.
cGMP Deviations; does not meet in process specification requirements
cGMP Deviations; does not meet in process specification requirements
cGMP Deviations; does not meet in process specification requirements
cGMP Deviations; does not meet in process specification requirements
cGMP Deviations; does not meet in process specification requirements
cGMP Deviations; does not meet in process specification requirements
Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012. FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared.
Subpotent (Single Ingredient Drug): Low assay at the 6-month test interval.
Subpotent (Single Ingredient Drug): Low assay at the 9-month test interval.
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