Why it was recalled
Subpotent: During long term stability testing of Levothyroxine Sodium Tablets USP for 88 mcg, the assay content was observed below the approved specification range.
Product description
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.
Lot numbers, UPCs & expiration codes
Lot # D2300045, Exp 12/31/2025.
Where it was sold
Nationwide in the US
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0006-2026
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- Sep 16, 2025
- FDA report date
- Oct 15, 2025
- Quantity
- 54,432 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- ACCORD HEALTHCARE, INC.
Original FDA data
Every field from FDA enforcement report D-0006-2026, exactly as published.
Show all FDA fields
- City
- Raleigh
- State
- NC
- Status
- Ongoing
- Country
- United States
- Event ID
- 97613
- Address
- 8041 Arco Corporate Dr Ste 200
- Code information
- Lot # D2300045, Exp 12/31/2025.
- Postal code
- 27617-2010
- Report date
- Oct 15, 2025
- Product type
- Drugs
- Recall number
- D-0006-2026
- Classification
- Class II
- Recalling firm
- ACCORD HEALTHCARE, INC.
- Product quantity
- 54,432 bottles
- Reason for recall
- Subpotent: During long term stability testing of Levothyroxine Sodium Tablets USP for 88 mcg, the assay content was observed below the approved specification range.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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.
- Distribution pattern
- Nationwide in the US
- Recall initiation date
- Sep 16, 2025
- Initial firm notification
- Letter
- Center classification date
- Oct 6, 2025