FDAFDA · Food and drugs·Recall number D-0006-2026
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.
Published October 15, 2025 · Recall initiated: September 16, 2025
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's 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
Voluntary: Firm initiated · Letter
Recall details
- Brand
- LEVOTHYROXINE SODIUM
- Manufacturer
- ACCORD HEALTHCARE, INC.
- Distributor
- Nationwide in the US
- UPC
- 0316729447157
- Lot
- Lot # D2300045, Exp 12/31/2025.
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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