Levothyroxine Sodium Tablets USP, 200 mcg recall — FDA D-0122-2025
Superpotent Drug and Subpotent Drug: potency failures obtained
Browse U.S. drug recall enforcement reports from the FDA in a structured, searchable format. Review the recalled product, reason, firm, status, dates, distribution information and FDA classification when available.
754 detailed records are currently available in this category.
Superpotent Drug and Subpotent Drug: potency failures obtained
Subpotent and Superpotent Drug
Superpotent Drug and Subpotent Drug: potency failures obtained
Superpotent Drug and Subpotent Drug: potency failures obtained
Superpotent Drug and Subpotent Drug: potency failures obtained
Superpotent Drug and Subpotent Drug: potency failures obtained
Defective Delivery System: incorrect silicone oil-free NormJect 10 mL Luer Lock Solo syringes packaged in the pack, instead of the required silicone oil-free NormJect 10 mL Luer Solo…
cGMP Deviations: Temperature excursion
Defective Container: Unable to get the solution out of the bottle as the spike of the cap was lodged in the nozzle of the product bottle.
Superpotent Drug and Subpotent Drug: potency failures obtained
Superpotent Drug and Subpotent Drug: potency failures obtained
cGMP Deviations: Presence of N-nitroso Cinacalcet impurity above FDA recommended interim limit
cGMP Deviations: Presence of N-nitroso-Desmethyl-Diltiazem impurity above FDA recommended interim limit.
cGMP Deviations: Presence of N-nitroso Cinacalcet impurity above FDA recommended interim limit
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above the recommended interim limit
Presence of Particulate Matter: Potential for glass delamination from the vials.
cGMP Deviations: Presence of N-nitroso-Desmethyl-Diltiazem impurity above FDA recommended interim limit.
Presence of Particulate Matter: Potential for glass delamination from the vials.
Labeling: Not Elsewhere Classified - Wrong NDC number
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above recommended interim limit
cGMP Deviations: Out of specification results for micro in hand soap products.
cGMP Deviations: Presence of N-nitroso-Desmethyl-Diltiazem impurity above FDA recommended interim limit.
cGMP Deviations: Presence of N-nitroso-Desmethyl-Diltiazem impurity above FDA recommended interim limit.
Presence of Particulate Matter: Potential for glass delamination from the vials.
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