United StatesLevothyroxine Sodium Tablets, USP 88 mcg (0.088 mg), 90 tablets per bottle, NDC 16729-450-15, Lot D2300045, exp 12/31/2025, manufactured for Accord Healthcare by Intas Pharmaceuticals, are being recalled. The recall was initiated because long-term stability testing showed the assay content was below the approved specification range (subpotent); the product was distributed nationwide in the US.
What's being recalled
Levothyroxine Sodium Tablets, USP, 88 mcg (0.088 mg), 90 Tablets per bottle, Rx Only, Manufactured for Accord Healthcare, Inc., Raleigh, NC 27617, Manufactured by: Intas Pharmaceuticals Limited, Camp Road, Selaqui, Dehradun-248 197, India, NDC 16729-450-15.
Recalling firm: Accord Healthcare, Inc., Raleigh, NC, United States.
How to identify it
Lot # D2300045, Exp 12/31/2025.
The hazard
Subpotent: During long term stability testing of Levothyroxine Sodium Tablets USP for 88 mcg, the assay content was observed below the approved specification range.
What to do
Don't stop taking a prescribed medicine without talking to your doctor or pharmacist first. For other products, stop using them and ask the pharmacist, seller or maker what to do.
The notice doesn't give instructions for consumers, so this is general advice for health & beauty recalls. Check the official notice for the details.
Where it was sold
Nationwide in the US
The official notice
This page is a summary of the notice published by U.S. Food and Drug Administration (enforcement reports), collected from U.S. Food and Drug Administration (enforcement reports). Check the original before you act on it.
Read the official notice (opens in a new tab)