Levothyroxine Sodium Tablets USP, 175 mcg, packaged in a) 90-count bottles (NDC 0378-1817-77) and b) 1000-count bottl... — FDA record D-0121-2025

Reported ongoing

Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.

Source date Nov 18, 2024. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.

Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.

What the record says

Product
Levothyroxine Sodium Tablets USP, 175 mcg, packaged in a) 90-count bottles (NDC 0378-1817-77) and b) 1000-count bottles (NDC 0378-1817-10), Rx only, Manufactured for: Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A.
Reason
Superpotent Drug and Subpotent Drug: potency failures obtained
Classification
Class II
Recalling firm
Viatris Inc
Quantity
19, 549 bottles
Agency-reported status
Ongoing
Source record identifier
D-0121-2025

Open the official record

What the recall classes mean. Classification is an agency assessment, not individual medical advice.

Lot and product identifiers

Label fieldDetails supplied by the agency
Lot, code or applicabilityLot #: a) 3192915, 8172108, Exp. Date Mar 2025; b) 3208680, Exp. Date Sep 2025

Match all identifying details in the current notice. A brand name alone is not enough.

Distribution

Nationwide within the United States and Puerto Rico

States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.

Dates in the source

Report date
Dec 18, 2024
Recall initiation date
Nov 18, 2024
Center classification date
Dec 12, 2024

FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.

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