Drug & medication recalls Moderate risk

Mylan Institutional, Inc. recalls Levothyroxine Sodium Tablets, USP, 125 mcg (0.125 mg), Rx Only, 100 Unit Dose Blister Cards of 10 (10 cards of 10 table…

Recall date
March 7, 2025
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
D-0291-2025
FDA classification
Class II
Brand / firm
Mylan Institutional, Inc.
Sold / distributed
Nationwide in the USA

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Levothyroxine Sodium Tablets, USP, 125 mcg (0.125 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 51079-443-20.

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