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Class II · ModerateActive recall

Levothyroxine Sodium

Could cause temporary or reversible harm; serious harm is unlikely.

Does this affect you?
Check your lot numberLot #: a) 8171623, Exp. Date Feb 2025; 8164486, Exp. Date Nov 2024 b)3205462, Exp. Date Aug 2025; 3192428, Exp. Date Feb 2025; 3184096, Exp. Date Nov 2024
Where it was soldNationwide within the United States and Puerto Rico
Find the lot number printed on your box or bottle. If it matches — and you take this medicine — call your pharmacist. Don't stop a prescribed medicine on your own.

What happened

Superpotent Drug and Subpotent Drug: potency failures obtained

What to do

  1. Check the lot number and expiry on your medicine against the recall above.
  2. Talk to your pharmacist or doctor before changing anything — don't stop on your own.
  3. Report any problems to FDA MedWatch (1-800-FDA-1088 or fda.gov/medwatch).

Who makes it

Made byMylan Pharmaceuticals Inc.
Brand nameLEVOTHYROXINE SODIUM
Generic nameLEVOTHYROXINE SODIUM
Active ingredient(s)LEVOTHYROXINE SODIUM
Distributed by / forMylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A
NDC0378-1811-77
Show the full FDA record
Full product labelLevothyroxine Sodium Tablets USP, 112 mcg, packaged in a) 90-count bottles (NDC 0378-1811-77) and b) 1000-count bottles (NDC 0378-1811-10), Rx only, Manufactured for: Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A.
Recalling firmViatris Inc
DistributionNationwide within the United States and Puerto Rico
Quantity35,883 bottles
Recall initiated2024-11-18
Report date2024-12-18
Recall completed—
Recall numberD-0128-2025
ClassificationClass II
FDA statusOngoing
Origin on fileCanonsburg PA United States

Related

Levothyroxine recallsRecent drug recallsCheck another medication

Source: U.S. FDA enforcement database (openFDA). Look this up on the official FDA recalls site ↗

This is public FDA recall information, not medical advice. A recall does not always mean your specific bottle is affected. Never stop a prescribed medicine without asking your pharmacist or doctor.