Severity
Moderate
FDA Drug recall · Reported January 9, 2013
Labeling: Error on Declared Strength. Product labeled to contain 150 mcg tablets actually contained 75 mcg tablets.
Abbott Laboratories recalled Synthroid (Levothyroxine Sodium) tablets, 150 mcg (0.15 mg), 90 tablets per bottle, Rx On… - a moderate-severity action.
Synthroid (Levothyroxine Sodium) tablets, 150 mcg (0.15 mg), 90 tablets per bottle, Rx On… was recalled by Abbott Laboratories in January 9, 2013. Reason: Labeling: Error on Declared Strength. Product labeled to contain 150 mcg tablets actually contained 75 mcg ta…. Check the official notice for the remedy. Verify recall #D-107-2013 with the FDA Drug before acting.
The recall
Abbott Laboratories issued this moderate-severity FDA Drug recall-Labeling: Error on Declared Strength. Product labeled to contain 150 mcg tablets actually contained 75 mcg ta….
Sourced from official FDA Drug enforcement records. Verify recall #D-107-2013 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
This FDA Drug action (record #D-107-2013) was formally reported on January 9, 2013, with the manufacturer initiating the action on December 4, 2012. It is classified under Moderate severity (Class II), with a current status of Terminated. Abbott Laboratories is listed as the recalling firm, operating out of Abbott Park, IL. Federal records list the affected scope as 28, 524 bottles.
The documented reason for this recall is: Labeling: Error on Declared Strength. Product labeled to contain 150 mcg tablets actually contained 75 mcg tablets. Distribution data in the federal record shows the product reached: US Nationwide and Puerto Rico. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Where this recall sits in its category - 3,731 children & baby products recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Severity
Moderate
Affected scope
28, 524 bottles
Related Recalls
6
0 from same agency
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.
Labeling: Error on Declared Strength. Product labeled to contain 150 mcg tablets actually contained 75 mcg tablets.
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | D-107-2013 |
| Date reported | January 9, 2013 |
| Date initiated | December 4, 2012 |
| Recalling firm | Abbott Laboratories |
| Firm location | Abbott Park, IL |
| Affected scope | 28, 524 bottles |
| Distribution | US Nationwide and Puerto Rico |
Profile values are sourced directly from the official FDA Drug enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
This page summarizes the official FDA Drug record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Drug, reported January 9, 2013. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.