Accord Healthcare, Inc.: Levothyroxine Sodium Tablets, Usp, 300 Mcg (0.3mg), 90 Tablets Bottles

Recall Summary Accord Healthcare is recalling Levothyroxine Sodium Tablets 300 mcg in 90-tablet bottles (NDC 16729-458-15) because the medication is subpotent—meaning it contains less active ingredient than it should. The affected product was distributed nationwide across all U.S. states. This is a Class II recall, indicating the product could cause adverse health effects in patients who rely on this thyroid medication.

Recalling firm
ACCORD HEALTHCARE, INC.
Product
Levothyroxine Sodium Tablets, USP, 300 mcg (0.3mg), 90 Tablets bottles, Rx only, Manufactured for: Accord Healthcare, Inc., Raleigh, NC 27617, Manufactured by: lntas Pharmaceuticals Limited, Camp Road, Selaqui, Dehradun-248 197, INDIA, NDC 16729-458-15.
Reason
Subpotent Drug
Classification
Class II
Category
drug recall
Country
United States
Agency
U.S. Food and Drug Administration
Recall date
2026-06-08
Status
Ongoing
Areas affected
AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...
Distribution
US Nationwide.

Official recall notice from U.S. Food and Drug Administration

Recall details on Nibble Recalls: https://trynibble.app/recalls/e377dd2d-039c-400e-9c51-7b013794cca7