FDAHealthSeptember 16, 2025
ACCORD HEALTHCARE, INC. — 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 Phar
⚠️ Subpotent: During long term stability testing of Levothyroxine Sodium Tablets USP for 88 mcg, the assay content was observed below the approved specification range.
Is this relevant to me?
- Geography
- Nationwide
- Source agency
- FDA
- Category
- Health
- Published
- September 16, 2025
Nationwide in the US
What's affected?
- Product
- 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.
- Brand
- LEVOTHYROXINE SODIUM
- UPC
- 0316729447157
- Lot code
- D2300045
Additional details
Lot # D2300045, Exp 12/31/2025.
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 54,432 bottles.
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