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Drug FDA Class II Ongoing Sub/super-potent

Levothyroxine Sodium Tablets, USP, 150 mcg (0.15 mg), Rx Only, 100 Unit Dose Blister Cards of 10 (10 cards of 10 tablets each) per carton, Mylan Pharmaceuticals Inc., Morgantown, WV 26505, Made in India, NDC 51079-445-20.

Mylan Institutional, Inc. Published Mar 26, 2025

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 Mylan Institutional, Inc. or your place of purchase with questions, and see the source record below for full details.
Reason for recall

Super-Potent Drug: Out of specification potency results were obtained.

Hazards

Superpotency · primary

Affected products (1)

Levothyroxine Sodium Tablets, USP, 150 mcg (0.15 mg), Rx Only, 100 Unit Dose Blister Cards of 10 (10 cards of 10 tablets each) per carton, Mylan Pharmaceuticals Inc., Morgantown, WV 26505, Made in India, NDC 51079-445-20.

LEVOTHYROXINE SODIUM · 347 Cartons

NDC: 51079-440, 51079-444, 51079-441, 51079-442, 51079-443, 51079-445, 51079-440-01, 51079-440-20, 51079-444-01, 51079-444-20, 51079-441-01, 51079-441-20, 51079-442-01, 51079-442-20, 51079-443-01, 51079-443-20, 51079-445-01, 51079-445-20
Lot codes: 3116074
Code info: Lot 3116074, Exp. 09/30/2025

Affected areas

Nationwide

Timeline

  1. Initiated
    Mar 7, 2025
  2. Published
    Mar 26, 2025
Recall number
D-0290-2025
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.