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Class II

Levothyroxine Sodium Tablets USP, 137 mcg, packaged in a) 90-count bottles (NDC 0378-1823-77) and b) 1000-count bottles (NDC 0378-1823-10), Rx only, Manufactured for: Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A.

Superpotent Drug and Subpotent Drug: potency failures obtained

Recall number
D-0119-2025
Report date
December 18, 2024
Classification
Class II
Status in dataset
Ongoing
Recalling firm
Viatris Inc
Generic names
LEVOTHYROXINE SODIUM
Brand names
LEVOTHYROXINE SODIUM
Product NDCs
0378-1800, 0378-1803, 0378-1805, 0378-1807, 0378-1809, 0378-1811, 0378-1813, 0378-1823, 0378-1815, 0378-1817, 0378-1819, 0378-1821

Code and lot information

Lot #: a) 8165919, Exp. Date Dec 2024; 8172050, Exp. Date Mar 2025; 8183251, Exp. Date Sept 2025 b) 3185542, Exp. date Dec 2024; 3192838, Exp. Date Mar 2025; 3208172, Exp. Date Sept 2025

Distribution

Nationwide within the United States and Puerto Rico

Do not stop or change a prescribed medication based only on this page.Contact your pharmacist or prescriber and compare the exact product, manufacturer, NDC, and lot information.

Source and limitations

This page reflects a public openFDA Drug Enforcement record. The dataset was last checked on September 23, 2026. openFDA states that enforcement data should not be used alone to issue public alerts or track the full lifecycle of a recall.

Review the official FDA Drug Recalls page and the underlying openFDA query.