Drug FDA Class II Ongoing Sub/super-potent

Levothyroxine Sodium Tablets, USP, 137 mcg (0.137 mg), 100 Tablets per carton (10 unit dose blister cards of 10 tablets each), Rx only, Manufactured for: Mylan Pharmaceuticals Inc., Morgantown, WV 26505 USA. NDC: 42292-041-20

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

Reason for recall

Subpotent and Superpotent Drug

Hazards

Subpotency and Superpotency · primary

Affected products (1)

Levothyroxine Sodium Tablets, USP, 137 mcg (0.137 mg), 100 Tablets per carton (10 unit dose blister cards of 10 tablets each), Rx only, Manufactured for: Mylan Pharmaceuticals Inc., Morgantown, WV 26505 USA. NDC: 42292-041-20

LEVOTHYROXINE SODIUM · 1,133 cartons

NDC: 42292-038, 42292-039, 42292-041, 42292-040, 42292-038-01, 42292-038-20, 42292-039-01, 42292-039-20, 42292-041-01, 42292-041-20, 42292-040-01, 42292-040-20

Code info: Lot #: 3115448, Exp. Date 12/31/2024;3115732, Exp. Date 3/31/2025; 3116024, Exp. Date 9/30/2025

Affected areas

Nationwide

Timeline

Initiated

Nov 19, 2024
Published

Dec 18, 2024

Recall number: D-0134-2025
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.