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Drug FDA Class II Ongoing Sub/super-potent

Levothyroxine 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.

Viatris Inc Published Dec 18, 2024

Risk level

Class II

May cause a temporary or reversible health problem; slight chance of serious harm.

Severity score 60/100

What should you do?

  • Check whether you have this product, using the lot codes, UPCs, and dates listed below.
  • Do not eat, serve, or sell the affected product.
  • Return it to the place of purchase for a refund, or throw it away in a sealed bag so people and animals can’t get to it.
  • Contact Viatris Inc or your place of purchase with questions, and see the source record below for full details.
Reason for recall

Superpotent Drug and Subpotent Drug: potency failures obtained

Hazards

Superpotency and Subpotency · primary

Affected products (1)

Levothyroxine 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.

LEVOTHYROXINE SODIUM · 35,883 bottles

NDC: 0378-1800, 0378-1803, 0378-1805, 0378-1807, 0378-1809, 0378-1811, 0378-1813, 0378-1823, 0378-1815, 0378-1817, 0378-1819, 0378-1821, 0378-1800-77, 0378-1800-10, 0378-1803-77, 0378-1803-10, 0378-1805-77, 0378-1805-10, 0378-1807-77, 0378-1807-10, 0378-1809-77, 0378-1809-10, 0378-1811-77, 0378-1811-10, 0378-1813-77, 0378-1813-10, 0378-1823-77, 0378-1823-10, 0378-1815-77, 0378-1815-10, 0378-1817-77, 0378-1817-10, 0378-1819-77, 0378-1819-10, 0378-1821-77
Code info: Lot #: 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

Affected areas

Nationwide

Timeline

  1. Initiated
    Nov 18, 2024
  2. Published
    Dec 18, 2024
Recall number
D-0128-2025
Agency
U.S. Food and Drug Administration
Country
US
Source data (openFDA JSON) About FDA enforcement reports

FDA records come from the openFDA drug enforcement-report dataset — the agency's full weekly enforcement list. Most entries are not issued as consumer press releases, so they won't appear on fda.gov/recalls or in a web search. The source record link above resolves this exact recall by its number.